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1. A European Observational Study to Evaluate the Safety and the Effectiveness of Safinamide in Routine Clinical Practice: The SYNAPSES Trial

Author

Abbruzzese, G., Kulisevsky, J., Bergmans, B., Gomez-Esteban, J. C., Kagi, G., Raw, J., Stefani, A., Warnecke, T., Jost, W. H., Bourgeois, P., Cras, P., de Klippel, N., Dethy, S., Franco, G., Garraux, G., Geens, K., Jacquerye, P., Jeanjean, A., Santens, P., Supiot, F., van der Linden, C., Blersch, W. K., Delf, M., Hellwig, B., Herbst, H. P., Kupsch, A., Lang, M., Muhlack, S., Nastos, I., Oehlwein, C., Schlegel, E., Schwarz, J., Woitalla, D., Aguggia, M., Avarello, T., Barone, P., Baruffaldi, R., Belgrado, E., Bentivoglio, A. R., Bosco, D., Calabresi, P., Callegarini, C., Cannas, A., Centonze, D., Ceravolo, R., Colosimo, C., Comi, C., Contardi, S., Cortelli, P., Cossu, G., D'Amelio, M., de Pandis, M. F., Denaro, A., Di Lazzaro, V., Fabbrini, G., Gasparoli, E., Guidi, M., Iliceto, G., Lopiano, L., Manganotti, P., Marconi, R., Marini, C., Marsala, S. Z., Mauri, M., Moleri, M., Monge, A., Morgante, F., Negrotti, A., Nordera, G., Onofrj, M., Pacchetti, C., Padovani, A., Pontieri, F. E., Priori, A., Quatrale, R., Sensi, M., Tamma, F., Tessitore, A., Tinazzi, M., Vitale, C., Volonte, M. A., Zappia, M., Zecchinelli, A. L., Arbelo Gonzalez, J. M., Bayes, A., Blazquez, M., Calopa Garriga, M., Callen, A., Campos Arillo, V., Cubo, E., de Fabregues, O., Escalante Arroyo, S., Espinosa Rosso, R., Esquivel Lopez, A., Freire, E., Garcia Cobos, E., Garcia Moreno, J. M., Gonzalez-Ardura, J., Grandas Perez, F., Kurtis, M., Juni, J., Legarda, I., Leiva, C., Lopez Aristegui, N., Lopez Manzanares, L., Lozano, J. J., Luquin, M. R., Martinez Castrillo, J. C., Marti Domenech, M. J., Martinez, I., Mata, M., Mir Rivera, P., Pascual Sedano, B., Rodriguez Oroz, M. C., Rodriguez Uranga, J. J., Sanchez, S., Santos Garcia, D., Solano, B., Vaamonde Gamo, J., Accolla, E., Bohlhalter, S., Kalin, A., Michelis, J., Carrol, C., Henderson, E., Raha, S., Silva, N., Silverdale, M., Universidad de Sevilla. Departamento de Medicina, Abbruzzese G., Kulisevsky J., Bergmans B., Gomez-Esteban J.C., Kagi G., Raw J., Stefani A., Warnecke T., Jost W.H., Bourgeois P., Cras P., de Klippel N., Dethy S., Franco G., Garraux G., Geens K., Jacquerye P., Jeanjean A., Santens P., Supiot F., van der Linden C., Blersch W.K., Delf M., Hellwig B., Herbst H.P., Kupsch A., Lang M., Muhlack S., Nastos I., Oehlwein C., Schlegel E., Schwarz J., Woitalla D., Aguggia M., Avarello T., Barone P., Baruffaldi R., Belgrado E., Bentivoglio A.R., Bosco D., Calabresi P., Callegarini C., Cannas A., Centonze D., Ceravolo R., Colosimo C., Comi C., Contardi S., Cortelli P., Cossu G., D'Amelio M., de Pandis M.F., Denaro A., Di Lazzaro V., Fabbrini G., Gasparoli E., Guidi M., Iliceto G., Lopiano L., Manganotti P., Marconi R., Marini C., Marsala S.Z., Mauri M., Moleri M., Monge A., Morgante F., Negrotti A., Nordera G., Onofrj M., Pacchetti C., Padovani A., Pontieri F.E., Priori A., Quatrale R., Sensi M., Tamma F., Tessitore A., Tinazzi M., Vitale C., Volonte M.A., Zappia M., Zecchinelli A.L., Arbelo Gonzalez J.M., Bayes A., Blazquez M., Calopa Garriga M., Callen A., Campos Arillo V., Cubo E., de Fabregues O., Escalante Arroyo S., Espinosa Rosso R., Esquivel Lopez A., Freire E., Garcia Cobos E., Garcia Moreno J.M., Gonzalez-Ardura J., Grandas Perez F., Kurtis M., Juni J., Legarda I., Leiva C., Lopez Aristegui N., Lopez Manzanares L., Lozano J.J., Luquin M.R., Martinez Castrillo J.C., Marti Domenech M.J., Martinez I., Mata M., Mir Rivera P., Pascual Sedano B., Rodriguez Oroz M.C., Rodriguez Uranga J.J., Sanchez S., Santos Garcia D., Solano B., Vaamonde Gamo J., Accolla E., Bohlhalter S., Kalin A., Michelis J., Carrol C., Henderson E., Raha S., Silva N., and Silverdale M.

Subjects
Research Report, Male, 0301 basic medicine, Benzylamines, Parkinson's disease, Outcome Assessment, Comorbidity, Disease, Real-life evaluation, chemistry.chemical_compound, 0302 clinical medicine, Outcome Assessment, Health Care, 80 and over, MAO-B inhibitor, Aged, 80 and over, Safinamide, education.field_of_study, Alanine, Mental Disorders, Parkinson Disease, Middle Aged, Aged, Drug-Related Side Effects and Adverse Reactions, Europe, Female, Follow-Up Studies, Humans, Monoamine Oxidase Inhibitors, Retrospective Studies, Settore MED/26 - NEUROLOGIA, Erratum, Cohort study, medicine.medical_specialty, Population, MEDLINE, 03 medical and health sciences, Cellular and Molecular Neuroscience, Internal medicine, medicine, Adverse effect, education, business.industry, medicine.disease, Health Care, 030104 developmental biology, chemistry, Parkinson’s disease, Observational study, Neurology (clinical), business, 030217 neurology & neurosurgery
Abstract

Background: Safinamide modulates both dopaminergic and glutamatergic systems with positive effects on motor and non-motor symptoms of Parkinson's disease (PD). The drug utilization study SYNAPSES was designed to investigate the use of safinamide in routine clinical practice, as recommended by the European Medicines Agency. Objective: To describe the occurrence of adverse events in PD patients treated with safinamide in real-life conditions. Methods: The SYNAPSES trial is an observational, European, multicenter, retrospective-prospective cohort study. Patients were followed up to 12 months with analyses performed in the overall population and in patients aged >75 years, with relevant comorbidities and with psychiatric conditions. Results: Of the 1610 patients included, 82.4% were evaluable after 12 months with 25.1% of patients >75 years, 70.8% with relevant comorbidities and 42.4% with psychiatric conditions. During observation 45.8% patients experienced adverse events, 27.7% patients had adverse drug reactions and 9.2% patients had serious adverse events. The adverse events were those already described in the patients' information leaflet. The majority were mild or moderate and completely resolved and no differences were detected between the subgroup of patients. Clinically significant improvements were seen in the UPDRS motor score and in the UPDRS total score in >= 40% of patients, according to the criteria developed by Shulman et al. Conclusion: The SYNAPSES study confirms the good safety profile of safinamide even in special groups of patients. Motor complications and motor scores improved with clinically significant results in the UPDRS scale maintained in the long-term.

Published
2022

2. The MITOS system predicts long-term survival in amyotrophic lateral sclerosis

Author

Tramacere, Irene, Dalla Bella, Eleonora, Chiò, Adriano, Mora, Gabriele, Filippini, Graziella, Lauria, Giuseppe, EPOS Trial Study Group, Antonini, G, Borghero, G, Capasso, M, Caponnetto, C, Lunetta, C, Corbo, M, Eleopra, R, Riva, N, Filosto, M, Giannini, Fabio, Granieri, E, La Bella, V, Logroscino, G, Mandrioli, J, Mazzini, L, Monsurrò, Mr, Pietrini, V, Quatrale, R, Rizzi, R, Salvi, F, Siciliano, G, Sorarù, G, Volanti, P., Tramacere I, D., Chiò, A., Mora, G., Filippini, G., Lauria, G, O., Borghero, G., Capasso, M., Caponnetto, C., Lunetta, C., Corbo, M., Eleopra, R., Riva, N., Filosto, M., Giannini, F., Granieri, E., La Bella, V., Logroscino, G., Mandrioli, J., Mazzini, L., Monsurrò, M., Pietrini, V., Quatrale, R., Rizzi, R., Salvi, F., Siciliano, G., Sorarù, G., Tramacere, Irene, Dalla Bella, Eleonora, Chiò, Adriano, Mora, Gabriele, Filippini, Graziella, Lauria, Giuseppe, EPOS Trial study group: Antonini, G, Borghero, Giuseppe, Capasso, M, Caponnetto, C, Lunetta, Christian, Corbo, M, Eleopra, R, Riva, N, Filosto, M, Giannini, F, Granieri, E, La Bella, V, Logroscino, G, Mandrioli, J, Mazzini, L, Monsurro', Maria Rosaria, Pietrini, V, Quatrale, R, Rizzi, R, Salvi, F, Siciliano, G, Sorarù, G, and Volanti, P.

Subjects
Male, Predictive Value of Test, Walking, Logistic regression, ALS, MOTOR NEURON DISEASE, NEUROMUSCULAR, RANDOMISED TRIALS, Adult, Aged, Amyotrophic Lateral Sclerosis, Communication, Deglutition, Disability Evaluation, Disease Progression, Double-Blind Method, Female, Humans, Middle Aged, Noninvasive Ventilation, Predictive Value of Tests, ROC Curve, Respiration, Self Care, Survival Analysis, Neurology (clinical), Psychiatry and Mental Health, Surgery, Arts and Humanities (miscellaneous), Medicine (all), law.invention, ALS, long-term survival, ALSFRS-R, Randomized controlled trial, law, Amyotrophic lateral sclerosis, Area under the curve, als, motor neuron disease, neuromuscular, randomised trials, Predictive value of tests, Settore MED/26 - Neurologia, Survival Analysi, Human, medicine.medical_specialty, NO, Swallowing, Internal medicine, medicine, Survival analysis, Receiver operating characteristic, business.industry, als, motor neuron disease, neuromuscular, randomised trials, adult, aged, amyotrophic lateral sclerosis, communication, deglutition, disability evaluation, disease progression, double-blind method, female, humans, male, middle aged, noninvasive ventilation, predictive value of tests, roc curve, respiration, self care, survival analysis, walking, neurology clinical, psychiatry and mental health, surgery, arts and humanities, medicine.disease, business, Amyotrophic Lateral Sclerosi
Abstract

ObjectiveThe choice of adequate proxy for long-term survival, the ultimate outcome in randomised clinical trials (RCT) assessing disease-modifying treatments for amyotrophic lateral sclerosis (ALS), is a key issue. The intrinsic limitations of the ALS Functional Rating Scale-Revised (ALSFRS-R), including non-linearity, multidimensionality and floor-effect, have emerged and its usefulness argued. The ALS Milano-Torino staging (ALS-MITOS) system was proposed as a novel tool to measure the progression of ALS and overcome these limitations. This study was performed to validate the ALS-MITOS as a 6-month proxy of survival in 200 ALS patients followed up to 18 months.MethodsAnalyses were performed on data from the recombinant human erythropoietin RCT that failed to demonstrate differences between groups for both primary and secondary outcomes. The ALS-MITOS system is composed of four key domains included in the ALSFRS-R scale (walking/self-care, swallowing, communicating and breathing), each with a threshold reflecting the loss of function in the specific ALSFRS-R subscores. Sensitivity, specificity and the area under the curve of the receiver operating characteristic curves of the ALS-MITOS system stages and ALSFRS-R decline at 6 months were calculated and compared with the primary outcome (survival, tracheotomy or >23-hour non-invasive ventilation) at 12 and 18 months Predicted probabilities of the ALS-MITO system at 6 months for any event at 12 and 18 months were computed through logistic regression models.ResultsDisease progression from baseline to 6 months as defined by the ALS-MITOS system predicted death, tracheotomy or >23-hour non-invasive ventilation at 12 months with 82% sensitivity (95% CI 71% to 93%, n=37/45) and 63% specificity (95% CI 55% to 71%, n=92/146), and at 18 months with 71% sensitivity (95% CI 61% to 82%, n=50/70) and 68% specificity (95% CI 60% to 77%, n=76/111). The analysis of ALS-MITOS and ALSFRS-R progression at 6-month follow-up showed that the best cut-off to predict survival at 12 and 18 months was 1 for the ALS-MITOS (ie, loss of at least one function) and a decline ranging from 6 to 9 points for the ALSFRS-R.ConclusionsThe ALS-MITOS system can reliably predict the course of ALS up to 18 months and can be considered a novel and valid outcome measure in RCTs.

Published
2015

3. Randomized trial of safinamide add‐on to levodopa in Parkinson's disease with motor fluctuations

Author

Borgohain, R, Szasz, J, Stanzione, P, Meshram, C, Bhatt, M, Chirilineau, D, Stocchi, F, Lucini, V, Giuliani, R, Forrest, E, Rice, P, Anand, R, Sahadulla, M, Kardan, U, Keshava, B, Kishore, A, Kothari, S, Krishna Murthy, J, Kumar, S, Pal, P, Mehta, N, Prabhakar, S, Pradhan, S, Roy, A, Sankhla, C, Sethi, P, Shah, A, Shankar, N, Shukla, R, Sowani, A, Srinivasa, R, Varma, M, Vasudevan, D, Sreenivas, P, Velmurugendran, C, Vijayan, K, Bajenaru, O, Bulboaca, A, Campeanu, A, Chirileanu, D, Muresanu, D, Panea, C, Popescu, C, Simu, M, Ticmeanu, M, Avarello, T, Bonuccelli, U, Eleopra, R, Onofrj, M, and Quatrale, R

Subjects
Male, Benzylamines, Levodopa, Parkinson's disease, Motor Activity, Placebo, Severity of Illness Index, law.invention, Dose-Response Relationship, Antiparkinson Agents, chemistry.chemical_compound, Double-Blind Method, Randomized controlled trial, law, Activities of Daily Living, Clinical endpoint, Humans, Medicine, MAO-B inhibitor, Research Articles, Aged, Dyskinesia, Safinamide, Alanine, Dose-Response Relationship, Drug, Female, Follow-Up Studies, Middle Aged, Parkinson Disease, Neurology (clinical), Neurology, safinamide, dyskinesia, business.industry, Parkinsonism, medicine.disease, chemistry, Anesthesia, Settore MED/26 - Neurologia, Drug, medicine.symptom, business, medicine.drug
Abstract

Levodopa is effective for the motor symptoms of Parkinson's disease (PD), but is associated with motor fluctuations and dyskinesia. Many patients require add-on therapy to improve motor fluctuations without exacerbating dyskinesia. The objective of this Phase III, multicenter, double-blind, placebo-controlled, parallel-group study was to evaluate the efficacy and safety of safinamide, an α-aminoamide with dopaminergic and nondopaminergic mechanisms, as add-on to l-dopa in the treatment of patients with PD and motor fluctuations. Patients were randomized to oral safinamide 100 mg/day (n = 224), 50 mg/day (n = 223), or placebo (n = 222) for 24 weeks. The primary endpoint was total on time with no or nontroublesome dyskinesia (assessed using the Hauser patient diaries). Secondary endpoints included off time, Unified Parkinson's Disease Rating Scale (UPDRS) Part III (motor) scores, and Clinical Global Impression-Change (CGI-C). At week 24, mean ± SD increases in total on time with no or nontroublesome dyskinesia were 1.36 ± 2.625 hours for safinamide 100 mg/day, 1.37 ± 2.745 hours for safinamide 50 mg/day, and 0.97 ± 2.375 hours for placebo. Least squares means differences in both safinamide groups were significantly higher versus placebo. Improvements in off time, UPDRS Part III, and CGI-C were significantly greater in both safinamide groups versus placebo. There were no significant between-group differences for incidences of treatment-emergent adverse events (TEAEs) or TEAEs leading to discontinuation. The addition of safinamide 50 mg/day or 100 mg/day to l-dopa in patients with PD and motor fluctuations significantly increased total on time with no or nontroublesome dyskinesia, decreased off time, and improved parkinsonism, indicating that safinamide improves motor symptoms and parkinsonism without worsening dyskinesia.

Published
2013

4. A Multicentric Prospective Incidence Study of Guillain-Barré Syndrome in Italy. The ITANG Study

Author

Benedetti, M, Pugliatti, M, Dalessandro, R, BEGHI, ETTORE, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Raschetti, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, AM, Borsato, C, Bortolotto, S, Bottacchi, EF, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, SI, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, AM, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, NA, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, FERRARESE, CARLO, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Giometto, B, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, DM, Passarella, B, Pavesi, G, Penza, MT, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, GM, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, MR, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, Zoccolella, S., Benedetti, Md, Pugliatti, M, D'Alessandro, R, Beghi, E, Chiò, A, Logroscino, G, Filippini, G, Galeotti, F, Massari, M, Santuccio, C, Comi, Giancarlo, Raschetti, R, ITANG Study, Group, Giometto, B, Benedetti, M, Dalessandro, R, Abruzzi, L, Agazzi, E, Agostoni, E, Ambrogio, L, Amidei, S, Arbasino, C, Argentiero, V, Arnaboldi, M, Baldini, D, Barki, R, Bassi, P, Basso, F, Belcastro, V, Bellotti, M, Bersano, E, Besana, R, Bettoni, L, Bezzi, G, Bianconi, C, Bondavalli, M, Bonometti, A, Borghi, A, Borsato, C, Bortolotto, S, Bottacchi, E, Bresolin, N, Bruno, S, Burlina, A, Cafasso, G, Callegarini, C, Calvo, A, Candeloro, E, Casano, A, Cattaneo, S, Cavallo, R, Cheldi, A, Ciardo, G, Cirignotta, F, Clerici, A, Clerici, R, Comi, G, Conti, R, Coppo, F, Covelli, V, Crespi, V, Currò Dossi, M, Curtò, N, D'Adda, E, Dallocchio, C, D'Anna, S, De Massis, P, De Toni Franceschini, L, Di Vito, N, Didonè, G, Dileone, M, Donati, E, Dotta, M, Fazio, R, Federico, F, Ferrarese, C, Ferrazzini, F, Ferrero, B, Filosto, M, Frasson, E, Fusina, S, Galbussera, A, Gastaldo, E, Geda, C, Ghiglione, P, Gionco, M, Giorgetti, A, Giussani, G, Gobbin, F, Grampa, G, Granieri, E, Greco, G, Guidetti, D, Guidi, C, Guidotti, M, Gusmaroli, G, Imperiale, D, Internò, S, Jann, S, La Spina, I, Leo, A, Leone, M, Leoni, S, Leotta, D, Lerario, R, Liotta, G, Livrea, P, Luda di Cortemiglio, E, Maggio, B, Magni, E, Magnoni, A, Maistrelli, J, Manca, D, Mandrioli, J, Manera, U, Marcello, N, Marchi, P, Marchini, C, Marconi, S, Mattioli, M, Mauro, A, Mazzaglia, G, Medici, D, Meineri, P, Meola, G, Micaglio, G, Michelucci, R, Michieli, G, Micieli, G, Minardi, C, Moglia, C, Monaco, S, Montanari, E, Moretto, G, Munerati, V, Mura, G, Mussutto, V, Nascimbene, C, Neri, W, Nichelli, P, Nobile Orazio, E, Oddenino, E, Onorato, S, Padovani, A, Palermo, M, Papurello, D, Passarella, B, Pavesi, G, Penza, M, Perini, M, Perini, F, Perla, F, Perlotto, N, Perrone, P, Pignatta, P, Pisano, F, Poglio, F, Polo, A, Poloni, M, Porazzi, D, Pradotto, L, Previdi, P, Quatrale, R, Rasi, F, Ravasio, A, Ravetti, C, Repaci, M, Riccardi, T, Riguzzi, P, Rinaldi, R, Riva, M, Romeo, V, Romorini, A, Rosso, T, Rotondo, G, Sacquegna, T, Sanson, F, Santamato, V, Santoro, D, Sartori, V, Sasanelli, F, Savio, K, Serena, M, Silani, V, Silvestri, L, Simioni, V, Squintani, G, Suardelli, M, Tartagla, L, Terenghi, F, Terlizzi, E, Terzano, M, Tesser, F, Testa, L, Ticca, A, Ticozzi, N, Tiriticco, M, Tola, M, Tonietti, S, Trianni, G, Trojano, M, Trotta, F, Turatti, M, Ursino, E, Vanotti, A, Vercellino, M, Villani, A, Vitelli, E, Zambito Marsala, S, Zanette, G, Zarcone, D, Zimatore, G, and Zoccolella, S

Subjects
Adult, Male, Pediatrics, medicine.medical_specialty, Epidemiology, Population, Guillain-Barre Syndrome, Rate ratio, NO, Young Adult, Axonal and demyelinating GBS, Guillain-Barré syndrome, Incidence, Prospective study, Trend, Neurology (clinical), Aged, Aged, 80 and over, Female, Humans, Italy, Middle Aged, 80 and over, medicine, Young adult, education, Prospective cohort study, education.field_of_study, Guillain-Barre syndrome, business.industry, Medicine (all), Incidence (epidemiology), medicine.disease, Vaccination, Settore MED/26 - NEUROLOGIA, business, Human
Abstract

Background: To assess Guillain-Barré syndrome (GBS) incidence we relied on the Italian Network for the study of GBS (ITANG) established in 2010 in 7 Italian regions to analyse the association between influenza vaccination and GBS. Methods: All individuals aged ≥18 years, presenting with clinical manifestations that suggested GBS according to the universally accepted Asbury's diagnostic criteria (1990) were prospectively notified to a centralised database by ITANG neurologists over the period October 1, 2010-September 30, 2011. Through a telephone survey, 9 trained interviewers followed up the cases to diagnosis and then for 1 year since hospital discharge. Validation of case reporting was performed with the support of administrative data in 5 regions. Results: We found 365 cases fulfilling the definition for GBS or one of its variants over 19,846,068 population ≥18 years of age, yielding an annual incidence rate of 1.84 per 100,000 (95% CI 1.65-2.03), 2.30 (95% CI 1.99-2.60) in men and 1.41 (95% CI 1.18-1.64) in women. A highly significant peak of incidence was observed in February 2011 as compared to reference month (September 2011, rate ratio 3.3:1, p < 0.01). Conclusions: In Italy, GBS incidence was among the highest reported in Europe and higher than previously observed in Italian studies.

Published
2015

5. Non-motor symptoms in atypical and secondary parkinsonism: the PRIAMO study

Author

Colosimo, C, Morgante, L, Antonini, A, Barone, P, Avarello, Tp, Bottacchi, E, Cannas, A, Ceravolo, Mg, Ceravolo, R, Cicarelli, G, Gaglio, Rm, Giglia, L, Iemolo, F, Manfredi, M, Meco, G, Nicoletti, A, Pederzoli, M, Petrone, A, Pisani, A, Pontieri, Fe, Quatrale, R, Ramat, S, Scala, R, Volpe, G, Zappulla, S, Bentivoglio, Ar, Stocchi, F, Trianni, G, Del Dotto, P, Simoni, L, Marconi, R, Priamo, Sg, Benincasa, D, Biguzzi, S, Braga, M, Capecci, M, Caravona, N, D'Asta, G, De Falco, Fa, De Gaspari, D, Pezzoli, G, Di Giovanni, M, Floris, G, Gallerini, S, Grasso, L, Gurgone, G, Kiferle, L, Meoni, S, Morgante, F, Savica, R, Moschella, V, Pepe, F, Petretta, V, Randisi, Mg, Romeno, M, Santangelo, G, Ianniciell, M, Sorbello, V, Fabbrini, G, Berardelli, A, Guidubaldi, A, Muoio, R, Toni, V, Logi, C, Ciacci, G, Ulivelli, M, Perini, M, Lanfranchi, S, Griffini, S, Troianiello, B, Baratti, M, Amidei, S, Consoli, D, Iellamo, M, Cuomo, T, Scaglioni, A, Medici, D, Abbruzzese, Giovanni, Di Brigida, G, Cocco, Ga, Agnetti, V, Cossu, G, Deriu, M, Abrignani, M, Modica, C, Albani, G, Milan, E, Martinelli, P, Scaglione, C, Mucchiut, M, Zanini, S, Pennisi, F, Soliveri, P, Albanese, A, Bartolomei, L, L'Erario, R, Capus, L, Ferigo, L, Marano, R, Nastasi, V, Luciano, R, Maiello, L, Simone, P, Fogli, D, Lopiano, L, Pesare, M, Nordera, G, Pilleri, E, Scaravilli, T, Giaccaglini, E, Alesi, C, Corbetta, T, Dumitriu, A, Sgarbi, S, Rapisarda, A, Rizzoli, S, Zanoli, L, Manfredi, A., Colosimo C., Morgante L., Antonini A., Barone P., Avarello T.P., Bpttacchi E., Cannas A., Ceravolo M.G., Ceravolo R., Cicarelli G., Gaglio R.M., Giglia L., Iemolo F., Manfredi M., Meco G., Nicoletti A., Pederzoli M., Petrone A., Pisani A., Pontieri FE., Quatrale r., Ramat S., Scala R., Volpe G., Zappulla S., Bentivoglio A.R., Stocchi F., Trianni G., Del Dotto P., Simoni L., Marconi R., PRIAMO STUDY GROUP [.., Martinelli P., ], Colosimo, C, Morgante, L, Antonini, A, Barone, Paolo, Avarello, Tp, Bottacchi, E, Cannas, A, Ceravolo, Mg, Ceravolo, R, Cicarelli, G, Gaglio, Rm, Giglia, L, Iemolo, F, Manfredi, M, Meco, G, Nicoletti, A, Pederzoli, M, Petrone, A, Pisani, A, Pontieri, Fe, Quatrale, R, Ramat, S, Scala, R, Volpe, G, Zappulla, S, Bentivoglio, Ar, Stocchi, F, Trianni, G, Del Dotto, P, Simoni, L, Marconi, R, and PRIAMO STUDY, G. R. O. U. P.

Subjects
Male, Secondary, Neurology, secondary parkinsonism, parkinson and cognitive impairment, Neurological disorder, PRIAMO STUDY, Orthostatic vital signs, Prevalence, Corticobasal degeneration, Supranuclear Palsy, Longitudinal Studies, Parkinsonism, Cognitive disorder, Parkinson Disease, Neurodegenerative Diseases, Middle Aged, non-motor symptoms, atypical parkinsonism, Italy, Atypical parkinsonism, Non-motor symptoms, Parkinson and cognitive impairment, Secondary parkinsonism, epidemiology, Settore MED/26 - Neurologia, Female, Supranuclear Palsy, Progressive, Lewy Body Disease, medicine.medical_specialty, Humans, Aged, Parkinson Disease, Secondary, Cross-Sectional Studies, Multiple System Atrophy, Parkinsonian Disorders, Atypical parkinsonism, Non-motor symptoms, Parkinson and cognitive impairment, Secondary parkinsonism, Neurology (clinical), Aged, Cross-Sectional Studies, Female, Humans, Italy, epidemiology, Lewy Body Disease, epidemiology, Longitudinal Studies, Male, Middle Aged, Multiple System Atrophy, epidemiology, Neurodegenerative Diseases, epidemiology, Parkinson Disease, epidemiology, Parkinsonian Disorders, epidemiology, Prevalence, Supranuclear Palsy, Progressive, Progressive supranuclear palsy, Internal medicine, mental disorders, medicine, Dementia with Lewy bodies, business.industry, medicine.disease, nervous system diseases, Physical therapy, business, PARKINSONISM
Abstract

The PRIAMO study is a cross-sectional longitudinal observational study aimed at describing epidemiology and evolution of non-motor symptoms (NMS) in patients with different forms of parkinsonism recruited in 55 Italian centres and evaluated over 24 months. In this paper, we are reporting prevalence and clinical characteristics of NMS in patients with atypical and secondary parkinsonism. Out of 1307 consecutive patients with a diagnosis of parkinsonism, 83 patients had vascular parkinsonism (VP), 34 had multiple system atrophy (MSA), 30 had progressive supranuclear palsy (PSP), 14 had dementia with Lewy bodies (DLB) and 11 had corticobasal degeneration (CBD). MSA and DLB had the highest number of NMS domains and symptoms, respectively. Gastrointestinal symptoms, pain, urinary problems and postural instability due to orthostatic hypotension were most frequent in MSA. Sleep disturbances were also common with a prevalence of approximately 70% in all diagnostic groups but CBD (36%). Psychiatric symptoms and attention and memory impairment were frequently observed in all diagnoses but were most prevalent among DLB patients, whereas the prevalence of skin and respiratory disorders was rather low in all forms, ranging between 10 and 30%. Atypical parkinsonism patients also reported a low QoL, with no significant differences among the different forms, whereas PD and VP patients had a better QoL.

Published
2009

6. The PRIAMO study: A multicenter assessment of nonmotor symptoms and their impact on quality of life in Parkinson's disease

Author

Barone P., Antonini A., Colosimo C., Marconi R., Morgante L., Avarello T. P., Bottacchi E., Cannas A., Ceravolo G., Ceravolo R., Cicarelli G., Gaglio R. M., Giglia R. M., Iemolo F., Manfredi M., Meco G., Nicoletti A., Pederzoli M., Petrone A., Pisani A., Pontieri F. E., Quatrale R., Ramat S., Scala R., Volpe G., Zappulla S., Bentivoglio A. R., Stocchi F., Trianni G., Dotto P. D., PRIAMO study group, Martinelli P., Barone, Paolo, Antonini, A, Colosimo, C, Marconi, R, Morgante, L, Avarello, Tp, Bottacchi, E, Cannas, A, Ceravolo, G, Ceravolo, R, Cicarelli, G, Gaglio, Rm, Giglia, Rm, Iemolo, F, Manfredi, M, Meco, G, Nicoletti, A, Pederzoli, M, Petrone, A, Pisani, A, Pontieri, Fe, Quatrale, R, Ramat, S, Scala, R, Volpe, G, Zappulla, S, Bentivoglio, Ar, Stocchi, F, Trianni, G, Dotto, Pd, PRIAMO study, g. r. o. u. p., Barone P., Antonini A., Colosimo C., Marconi R., Morgante L., Avarello T.P., Bottacchi E., Cannas A., Ceravolo G., Ceravolo R., Cicarelli G., Gaglio R.M., Giglia R.M., Iemolo F., Manfredi M., Meco G., Nicoletti A., Pederzoli M., Petrone A., Pisani A., Pontieri F.E., Quatrale R., Ramat S., Scala R., Volpe G., Zappulla S., Bentivoglio A.R., Stocchi F., Trianni G., Dotto P.D., PRIAMO study group [.., Martinelli P., and ]

Subjects
Male, Pediatrics, Parkinson's disease, Nonmotor symptoms, Gastrointestinal Diseases, Anxiety, Antiparkinson Agents, Olfaction Disorders, Cognition, Quality of life, Apathy, complications/drug therapy/psychology, Depression (differential diagnoses), Fatigue, Depression, Parkinson Disease, Middle Aged, Psychiatric symptoms, Aged, Cognition Disorders, Female, Humans, Italy, Pain, Sleep Disorders, Intrinsic, Urination Disorders, Quality of Life, Neurology (clinical), Neurology, Settore MED/26 - NEUROLOGIA, epidemiology, medicine.symptom, Psychology, epidemiology/etiology/psychology, medicine.medical_specialty, Drooling, Aged, Antiparkinson Agents, therapeutic use, Anxiety, epidemiology/etiology/psychology, Cognition Disorders, epidemiology/etiology/psychology, Depression, epidemiology/etiology/psychology, Fatigue, epidemiology/etiology/psychology, Female, Gastrointestinal Diseases, epidemiology/etiology/psychology, Humans, Italy, epidemiology, Male, Middle Aged, Olfaction Disorders, epidemiology/etiology/psychology, Pain, epidemiology/etiology/psychology, Parkinson Disease, complications/drug therapy/psychology, Quality of Life, Sleep Disorders, Intrinsic, epidemiology/etiology/psychology, Urination Disorders, medicine, Nocturia, Urination disorder, medicine.disease, therapeutic use, Physical therapy, MULTICENTER STUDY, PARKINSON, Sleep Disorders
Abstract

We performed a multicenter survey using a semistructured interview in 1,072 consecutive patients with Parkinson's disease (PD) enrolled during 12 months in 55 Italian centers to assess the prevalence of nonmotor symptoms (NMSs), their association with cognitive impairment, and the impact on patients' quality of life (QoL). We found that 98.6% of patients with PD reported the presence of NMSs. The most common were as follows: fatigue (58%), anxiety (56%), leg pain (38%), insomnia (37%), urgency and nocturia (35%), drooling of saliva and difficulties in maintaining concentration (31%). The mean number of NMS per patient was 7.8 (range, 0-32). NMS in the psychiatric domain were the most frequent (67%). Frequency of NMS increased along with the disease duration and severity. Patients with cognitive impairment reported more frequently apathy, attention/memory deficit, and psychiatric symptoms. Apathy was the symptom associated with worse PDQ-39 score but also presence of fatigue, attention/memory, and psychiatric symptoms had a negative impact on QoL. These findings further support a key role for NMS in the clinical frame of PD and the need to address them specifically in clinical trials using dedicated scales.

Published
2009

7. Frontal assessment battery scores and non-motor symptoms in parkinsonian disorders

Author

Marconi, R., Grasso, L., Antonini, A., De Gaspari, D., Barone, P., Santangelo, G., Colosimo, C., Meco, G., Avarello, T. P., Bottacchi, E., Cannas, A., Ceravolo, M. G., Ceravolo, R., Cicarelli, G., Gaglio, R. M., Giglia, L., Iemolo, F., Manfredi, M., Nicoletti, A., Pederzoli, M., Petrone, A., Pisani, A., Pontieri, F. E., Quatrale, R., Ramat, S., Scala, R., Volpe, G., Zappulla, S., Bentivoglio, R., Stocchi, F., Trianni, G., Del Dotto, P., Morgante, F., Morgante, L., Fabbrini, G., Benincasa, D., Sensi, M., Braga, M., Capecci, M., Caravona, N., D'Asta, G., De Falco, F. A., Pezzoli, G., Di Giovanni, M., Floris, G., Gallerini, S., Gurgone, G., Frosini, D., Meoni, S., Savica, R., Moschella, V., Pepe, F., Petretta, V., Randisi, M. G., Romeno, M., Picillo, M., Sorbello, V., Tiple, D., Guidubaldi, A., Muoio, R., Toni, V., Logi, C., Bartalini, S., Ulivelli, M., Perini, M., Lanfranchi, S., Griffini, S., Troianiello, B., Baratti, M., Amidei, S., Consoli, D., Iellamo, M., Cuomo, T., Scaglioni, A., Medici, D., Abbruzzese, G., Di Brigida, G., Cocco, G. A., Agnetti, V., Cossu, G., Deriu, M., Abrignani, M., Modica, C., Albani, G., Pradotto, L., Martinelli, P., Scaglione, C., Mucchiut, M., Zanini, S., Pennisi, F., Soliveri, P., Albanese, A., Bartolomei, L., L'Erario, R., Capus, L., Ferigo, L., Marano, R., Nastasi, V., Luciano, R., Maiello, L., Simone, P., Fogli, D., Lopiano, L., Pesare, M., Nordera, G., Pilleri, E., Scaravilli, T., Giaccaglini, E., Alesi, C., Corbetta, T., Sgarbi, S., Rapisarda, A., Rizzoli, S., Zanoli, L., Manfredi, A., Marconi, R, Antonini, A, Barone, P, Colosimo, C, Avarello, Tp, Bottacchi, E, Cannas, A, Ceravolo, Mg, Ceravolo, R, Cicarelli, G, Gaglio, Rm, Giglia, L, Iemolo, F, Manfredi, M, Meco, G, Nicoletti, A, Pederzoli, M, Petrone, A, Pisani, A, Pontieri, Fe, Quatrale, R, Ramat, S, Scala, R, Volpe, G, Zappulla, S, Bentivoglio, Ar, Stocchi, F, Trianni, G, Del Dotto, P, De Gaspari, D, Grasso, L, Morgante, F, Santangelo, Gabriella, Fabbrini, G, Morgante, L, and PRIAMO study, Group

Subjects
Questionnaires, Lung Diseases, Male, Aged, Aged, 80 and over, Attention Deficit Disorder with Hyperactivity, Cardiovascular Diseases, Cognition Disorders, Fatigue, Female, Frontal Lobe, Gastrointestinal Diseases, Humans, Kidney Diseases, Logistic Models, Longitudinal Studies, Middle Aged, Parkinsonian Disorders, Predictive Value of Tests, Skin Diseases, Sleep Wake Disorders, Surveys and Questionnaires, Neuropsychological Tests, 2708, Neurology (clinical), Psychiatry and Mental Health, Neurology, Disease, Logistic regression, Parkinson and cognitive impairment, 80 and over, Verbal fluency test, Neuroradiology, Sleep Disorders, General Medicine, non-motor symptoms, Psychiatry and Mental health, Settore MED/26 - NEUROLOGIA, Frontal lobe, Predictive value of tests, Psychology, medicine.medical_specialty, Dermatology, behavioral disciplines and activities, Internal medicine, medicine, Psychiatry, Surrogate endpoint, Frontal functions, Non-motor symptoms, frontal functions, parkinson and cognitive impairment
Abstract

Using data from the PRIAMO study, we investigated non-motor symptoms (NMS) versus frontal lobe dysfunction in patients with idiopathic Parkinson disease (PD); 808 patients with PD and 118 with atypical parkinsonisms (AP) were consecutively enrolled at 55 Centers in Italy. Twelve categories of NMS were investigated. Cognitive impairment was defined as a Mini-Mental Status Evaluation score ≤ 23.8 and frontal lobe dysfunction as a Frontal Assessment Battery (FAB) score ≤ 3.48. Multivariable logistic regression was used to identify predictor of frontal lobe dysfunction in 524 PD patients, and a generalized linear model was used for each of the six FAB items. Not only the total FAB scores but also the single FAB items were lower in AP versus PD (p ≤ 0.005). Age (OR = 1.05), cognitive impairment (OR = 9.54), lack of cardiovascular symptoms (OR = 3.25), attention or memory problems (OR = 0.59) and treatment with L: -DOPA (OR = 5.58) were predictors of frontal lobe dysfunction. MMSE was negatively associated with all FAB items (β ≤ -0.16) and age with all FAB items but prehension behavior (β ≤ -0.01). Previous use of L: -DOPA was negatively associated with verbal fluency (β = -0.32) possibly acting as surrogate marker of disease duration. Cognitive impairment is a predictor of frontal lobe dysfunction. Among NMS, lack of attention or memory problems were negatively associated with frontal impairment. Further studies are nonetheless needed to better identify the predictors of frontal impairment in PD patients.

Published
2012

8. Two-year, randomized, controlled study of safinamide as add-on to levodopa in mid to late Parkinson's disease

Author

Borgohain, Rupam, Szasz, Jozsef, Stanzione, Paolo, Meshram, Chandrashekhar, Bhatt, Mohit H., Chirilineau, Dana, Stocchi, Fabrizio, Lucini, Valentina, Giuliani, Rodolfo, Forrest, Emma, Rice, Patricia, Anand, Ravi, Illiyas Sahadulla, M., Kardan, U., Keshava, B. S., Kishore, A., Kothari, S. S., Krishna Murthy, J. M., Kumar, S., Kumar Pal, P., Mehta, N., Prabhakar, S., Prabhakar, S. K. r., Pradhan, S., Roy, A. K., Sankhla, C., Sethi, P. K., Shah, A. B., Shankar, N., Shukla, R., Sowani, A., Srinivasa, R., Varma, M., Vasudevan, D., Vavilikolanu Sreenivas, P., Velmurugendran, C. U., Vijayan, K., Bajenaru, O., Bulboaca, A., Campeanu, A., Chirileanu, D., Muresanu, D., Panea, C., Popescu, C., Simu, M., Szasz, J., Ticmeanu, M., Avarello, T., Bonuccelli, Ubaldo, Eleopra, R., Onofrj, M., Quatrale, R., Stanzione, P., and Stocchi, F.

Subjects
Male, Benzylamines, Dyskinesia, Drug-Induced, Parkinson's disease, International Cooperation, law.invention, Antiparkinson Agents, Levodopa, chemistry.chemical_compound, Randomized controlled trial, law, Clinical endpoint, Medicine, add-on, Longitudinal Studies, Safinamide, Alanine, Medicine (all), safinamide, motor function, Parkinson Disease, Middle Aged, Treatment Outcome, Neurology, Settore MED/26 - Neurologia, Female, medicine.symptom, Drug, dopamine, medicine.drug, medicine.medical_specialty, Addon, Placebo, Dose-Response Relationship, Double-Blind Method, Internal medicine, Humans, safinamide, Parkinson's disease, levodopa, Aged, Dyskinesia, Dose-Response Relationship, Drug, business.industry, medicine.disease, Discontinuation, chemistry, Drug-Induced, Physical therapy, Dopamine, Motor function, Neurology (clinical), business
Abstract

In a 6-month double-blind, placebo-controlled study of Parkinson's disease patients with motor fluctuations, safinamide 50 and 100 mg/d significantly increased ON-time without increasing dyskinesia. Further long-term safinamide use in these patients was evaluated over an additional 18 months. Patients continued on their randomized placebo, 50, or 100 mg/d safinamide. The primary endpoint was change in Dyskinesia Rating Scale total score during ON-time over 24 months. Other efficacy endpoints included change in ON-time without troublesome dyskinesia, changes in individual diary categories, depressive symptoms, and quality of life measures. Change in Dyskinesia Rating Scale was not significantly different in safinamide versus placebo groups, despite decreased mean total Dyskinesia Rating Scale with safinamide compared with an almost unchanged score in placebo. Ad hoc subgroup analysis of moderate to severe dyskinetic patients at baseline (36% of patients) showed a decrease with safinamide 100 mg/d compared with placebo (P = 0.0317). Improvements in motor function, activities of daily living, depressive symptoms, clinical status, and quality of life at 6 months remained significant at 24 months. Adverse events and discontinuation rates were similar with safinamide and placebo. This 2-year, controlled study of add-on safinamide in mid-to-late Parkinson's disease with motor fluctuations, although not demonstrating an overall difference in dyskinesias between patients and controls, showed improvement in dyskinesia in patients at least moderately dyskinetic at baseline. The study additionally demonstrated significant clinical benefits in ON-time (without troublesome dyskinesia), OFF-time, activities of daily living, motor symptoms, quality of life, and symptoms of depression.

Published
2014

9. Validation of the Italian version of Parkinson's disease-cognitive rating scale (PD-CRS)

Author

Santangelo, G., Barone, P., Abbruzzese, G., Ferini Strambi, L., Antonini, A, Bandettini, M., Fabbrini, G., Di Stasio, F., Tinazzi, M., Bovi, T., Ramat, S., Meoni, S., Pezzoli, G., Siri, C., Canesi, M., Martinelli, P., Scaglione, C. L., Rossi, A., Tambasco, N., Picillo, M., Morgante, Letterio, Morgante, Francesca, Quatrale, R., Sensi, M. C., Pilleri, M., Biundo, R., Nordera, G., Caria, A., Pacchetti, C., Zangaglia, R., Lopiano, L., Zibetti, M., Morgante, L., Morgante, F., Zappia, M., Nicoletti, A., Quattrone, A., Salsone, M., Cossu, G., Murgia, D., Albanese, A., Del Sorbo, F., Santangelo, Gabriella, Barone, Paolo, Abbruzzese, Giovanni, Ferini-strambi, Luigi, and Antonini, Angelo

Subjects
Male, medicine.medical_specialty, Parkinson's disease, Neurology, Dermatology, Audiology, Neuropsychological Tests, Cognition Disorder, Cognitive dysfunction, Rating scale, medicine, Dementia, Humans, Cognitive dysfunctions, Mild cognitive impairment, Parkinson's Disease Cognitive Rating Scale (PD-CRS), Aged, Cognition Disorders, Female, Italy, Middle Aged, Parkinson Disease, Neurology (clinical), Psychiatry and Mental Health, 2708, Psychiatry, Working memory, Cognition, General Medicine, medicine.disease, Confidence interval, Psychiatry and Mental health, Ceiling effect, Neuropsychological Test, Psychology, Human
Abstract

Cognitive impairment (CI) is a frequent feature associated with both early and advanced stages of Parkinson's disease (PD). An evaluation of cognitive functions is relevant to identify those parkinsonians at risk of developing dementia. In the present study, the Italian version of Parkinson's Disease-Cognitive Rating Scale (PD-CRS) assessing fronto-subcortical and cortical cognitive functions in PD was validated in 387 parkinsonians and was used to test the empirical validity of the item 1.1 (cognitive impairment) of the Italian version of MDS-UPDRS as screening tool for CI in PD. PD-CRS was free from floor and ceiling effect. The mean PD-CRS score was 76.1 (mean cortical score, 24.5 ± 4.6; mean subcortical score, 51.5 ± 17.5). The internal consistency was satisfactory (α = 0.89); corrected item-total correlation was 0.570 (naming) to 0.696 (working memory). The correlation between PD-CRS and part I-IV of MDS-UPDRS was weak. The low agreement between classification of PD sample into patients with mild cognitive impairment (PD-MCI), dementia (PD-D) and normal cognition (PD-NC) according to scores of item 1.1 and classification according to cutoff scores of PD-CRS for PD-MCI, PD-D and PD-NC indicated a poor empirical validity of item 1.1 of MDS-UPDRS as cognitive screening tool for CI in PD (Κ = 0.114; weighted Κ = 0.17; SE of Κ = 0.038; 95 % confidence interval from 0.040 to 0.1895). The Italian version of PD-CRS is an easy, consistent and valid tool for assessment of the cognitive cortical and subcortical impairments in PD. © 2013 Springer-Verlag.

Published
2013

10. Early DEtection of wEaring off in Parkinson disease: The DEEP study

Author

Stocchi, Fabrizio, Antonini, Angelo, Barone, Paolo, Tinazzi, Michele, Zappia, Maria, Onofrj, Marco, Ruggieri, Stefano, Morgante, Letterio, Bonuccelli, Ubaldo, Lopiano, Leonardo, Pramstaller, Peter, Albanese, Alberto, Attar, Mahmood, Posocco, V, Colombo, D, Abbruzzese, Giovanni, Stocchi, F, Vacca, L, Pramstaller, Pp, Facheris, M, Guidotti, M, Mario, E, Riboldazzi, G, Leva, S, Priori, A, Pezzoli, G, Margherita, C, Soliveri, P, Picco, D, Pisano, F, Scarzella, L, Tavella, A, Zibetti, M, Ottaviani, S, Valzania, F, Contarsi, S, Quatrale, R, Sensi, M, Ceravolo, R, Rossi, C, Cincotta, M, Vanni, P, Del Dotto, P, Ceravolo, Mg, Capecci, M, Marchese, R, Tamburini, T, Thomas, A, Borelli, I, Marconi, R, Grasso, L, Stanzione, P, Pisani, V, Bentivoglio, Anna Rita, Loria, Giovanna, De Pandis, Mf, Federici, G, Manzo, V, Mauro, A, Picillo, M, Modugno, N, Lamberti, P, Dell'Aquila, C, Cicarelli, G, Quattrone, A, Nicoletti, G, Cannas, A, Solla, P, Nicoletti, A, Morgante, F, D'Amelio, M, Terruso, V, Elopra, R, Mucchiut, M, Pilleri, M, Biundi, R, Nassetti, S, Michelucci, R., Stocchi, F, Antonini, A, Barone, P, Tinazzi, M, Zappia, M, Onofrj, M, Ruggieri, S, Morgante, L, Bonuccelli, U, Lopiano, L, Pramstaller, P, Albanese, A, Attar, M, Posocco, V, Colombo, D, D'Amelio, M, Abbruzzese, G, and DEEP Study Group

Subjects
Questionnaires, Adult, Male, Quality of life, Levodopa, medicine.medical_specialty, Pediatrics, Parkinson's disease, Treatment duration, Early detection, Disease, Antiparkinson Agents, Surveys and Questionnaires, medicine, 80 and over, Humans, Wearing-off, Aged, Aged, 80 and over, Wearing-off questionnaire, business.industry, Parkinson Disease, quality of life, wearing-off, wearing-off questionnaire, Middle Aged, medicine.disease, Quality of Life, Cross-Sectional Studies, Female, Neurology, Ambulatory, Physical therapy, Observational study, Settore MED/26 - Neurologia, Neurology (clinical), Geriatrics and Gerontology, business, medicine.drug
Abstract

Assessing the frequency of Wearing-Off (WO) in Parkinson's disease (PD) patients, and its impact on Quality of Life (QoL). METHODS: Consecutive ambulatory patients, who were on dopaminergic treatment for ≥ 1 year, were included in this multicentre, observational cross-sectional study. In a single visit, WO was diagnosed based on neurologist assessment as well as using the validated Italian version of a patient self-rated 19-question Wearing-Off Questionnaire (WOQ-19); WO was defined for scores ≥ 2. QoL was evaluated by the 8-item Parkinson's Disease Questionnaire (PDQ-8). RESULTS: 617 subjects were included, with a mean anti-Parkinson treatment duration of 6.6 ± 4.6 years, 87.2% were on levodopa treatment. Neurologists identified presence of WO in 351 subjects (56.9%), whereas 415 subjects (67.3%) were identified by the self-administered WOQ-19. In patients with a

Published
2013

11. The relationship between cerebral vascular disease and parkinsonism: The VADO study

Author

Antonini, A., Vitale, C., Barone, P., Cilia, R., Righini, A., Bonuccelli, U., Abbruzzese, G., Ramat, S., Petrone, A., Quatrale, R., Marconi, R., Ceravolo, R., Stefani, A., Lopiano, L., Zappia, M., Capus, L., Morgante, L., Tamma, F., Tinazzi, M., Colosimo, C., Guerra, U. P., Valzania, F., Fagioli, G., Distefano, A., Bagnato, A., Feggi, L., Anna, S., Maria Teresa Rosaria De Cristofaro, Nobili, F., Mazzuca, N., Baldari, S., Eleopra, R., Bestetti, A., Benti, R., Varrone, A., Volterrani, D., Massa, R., Stocchi, F., Schillaci, O., Dore, F., Zibetti, M., Castellano, G., Battista, S. G., and Giorgetti, G.

Subjects
Male, Pathology, Parkinson's disease, Parkinson’s disease, Vascular parkinsonism, Dopamine transporter SPECT imaging, Gastroenterology, Severity of Illness Index, Antiparkinson Agents, Cohort Studies, Levodopa, Basal ganglia, 80 and over, Medicine, Tomography, Aged, 80 and over, Parkinsonism, Parkinson Disease, Magnetic Resonance Imaging, Tomography, Emission-Computed, Single-Photon, Humans, Corpus Striatum, Aged, Cerebrovascular Disorders, Cross-Sectional Studies, Dopamine Plasma Membrane Transport Proteins, Middle Aged, Parkinsonian Disorders, Female, MR Imaging, Neurology, Frontal lobe, Settore MED/26 - Neurologia, medicine.symptom, medicine.drug, MR imaging, medicine.medical_specialty, Internal medicine, Severity of illness, business.industry, Vascular disease, medicine.disease, Dyskinesia, nervous system, Neurology (clinical), Emission-Computed, Geriatrics and Gerontology, business, Single-Photon
Abstract

Background The observation of gait abnormalities, parkinsonism and vascular lesions in elderly patients is often reported as vascular parkinsonism (VP). However the status of striatal dopamine transporter (DAT) and the effects of brain vascular lesions on motor features and levodopa responsiveness are poorly defined. Methods We recorded clinical features, chronic response to levodopa and vascular risk factors in a cross-sectional cohort of consecutive elderly patients with possible Parkinson's disease (PD) or VP recruited in 20 centers in Italy. Results We included a total of 158 patients. Onset of motor symptoms was asymmetric in 93 (59%) and symmetric in 65 patients (41%). Symmetric motor onset was associated with greater disease severity. Chronic levodopa response was positive in 75 (47.8%) and negative in 82 patients (52.2%). A negative response to levodopa was associated with greater frequency of symmetric onset of motor symptoms, worst disease severity, absence of dyskinesia and greater number of vascular risk factors. Frontal lobe showed largest vascular load. Striatal DAT was normal in 48 (30.4%) and abnormal in 110 (69.6%) patients. Patients with normal DAT binding showed higher vascular load at MRI. Significant predictive factors of worst disease severity and negative response to levodopa were hypertension, vascular lesions in basal ganglia/periventricular regions, and normal DAT uptake. Conclusions Multiple cerebral vascular lesions modify clinical presentation and severity in patients with parkinsonism and this is underlined by specific risk factors primarily hypertension. Striatal DAT assessment is helpful in identifying patients where therapy benefit is less likely.

Published
2012

12. The PRIAMO study: background, methods and recruitment

Author

Antonini, A, Colosimo, C, Marconi, R, Morgante, L, Barone, P, Priamo, Sg, Abbruzzese, Giovanni, Abrignani, M, Agnetti, V, Antonini Pezzoli, A, Avarello, T, Baratti, M, Bartolomei, L, Bentivoglio, A, Bottacchi, E, Bracco, F, Cannas, A, Capus, L, Ceravolo, M, Ceravolo, R, Ciacci, G, Cicarelli, G, Consoli, D, Cossu, G, Cuomo, T, De Pandis, M, Del Dotto, P, Gaglio, R, Giaccaglini, E, Giglia, L, Guidi, M, Iemolo, F, Lopiano, L, Luciano, R, Manfredi, M, Marini, P, Martinelli, P, Mauro, A, Meco, G, Mucchiut, M, Nastasi, G, Nordera, G, Pacchetti, C, Pederzoli, M, Pennisi, F, Perini, M, Petrone, A, Pontieri, F, Pramstaller, P, Quatrale, R, Scaglioni, A, Scala, R, Simone, P, Soliveri, P, Stanzione, P, Stocchi, F, Trianni, G, Troianiello, B, Volpe, G, Zàppia, M, Zappulla, S., Antonini, A, Colosimo, C, Marconi, R, Morgante, L, Barone, Paolo, PRIAMO study, g. r. o. u. p., Antonino A., Colosimo C., Marconi R., Morgante L., Barone P., on behalf of the PRIAMO study group [.., Martinelli P., and ]

Subjects
Male, Sleep Wake Disorders, medicine.medical_specialty, Pediatrics, Cross-sectional study, prevalence, Neurocognitive Disorders, Comorbidity, Dermatology, epidemiology, incidence, parkinsonism, Cohort Studies, Parkinsonian Disorders, Quality of life, Epidemiology, medicine, Humans, Dementia, Longitudinal Studies, Aged, business.industry, MULTICENTRIC STUDY, Patient Selection, Incidence (epidemiology), Parkinsonism, General Medicine, medicine.disease, Epidemiologic Studies, Psychiatry and Mental health, Cross-Sectional Studies, Autonomic Nervous System Diseases, Italy, Epidemiologic Research Design, MOTOR SYMPTOMS, Quality of Life, Physical therapy, Female, Neurology (clinical), PARKINSON, business, Cohort study
Abstract

PRIAMO (PaRkinson And non Motor symptOms) is an epidemiology study aimed to assess the prevalence and incidence of non-motor symptoms (NMS) in patients with parkinsonism. PRIAMO consists of two phases: (1) a transversal assessment of the prevalence of NMS and (2) a longitudinal observation with two follow-up visits at 12 and 24 months to establish the incidence of NMS. A secondary aim of PRIAMO is to study the relationship between NMS and quality of life. Patients with parkinsonism have been evaluated in 59 Neurology Centres widely distributed throughout Italy. PRIAMO has analysed a total of 1307 patients (out of 1325 initially enrolled). We expect that PRIAMO will substantially help to quantify the burden of NMS in patients with parkinsonism.

Published
2008

13. Erythropoietin in amyotrophic lateral sclerosis: a multicentre, randomized, double blind, placebo controlled, phase III study

Author

Lauria, G, Dalla Bella, E, Antonini, G, Borghero, G, Capasso, M, Caponnetto, C, Chiò, A, Corbo, M, Eleopra, R, Fazio, R, Filosto, M, Giannini, F, Granieri, E, La Bella, V, Logroscino, G, Mandrioli, J, Mazzini, L, Monsurrò, Mr, Mora, G, Pietrini, V, Quatrale, R, Rizzi, R, Salvi, F, Siciliano, G, Sorarù, G, Volanti, P, Tramacere, I, Filippini, G, Cazzato, D, Cesnik, E, Groppo, E, Sette, E, Pani, C, Costantino, E, Orlandini, F, Boi, D, Querin, G, D'Ascenzo, C, Sagnelli, A, Piccirillo, G, Aiello, M, Chetta, A, Grassi, A, Lunetta, C, Maestri, E, Padovani, A, Cotelli, M, Todeschini, A, Morino, S, Di Pasquale, A, Latino, P, Casali, S, Battistini, S, Pirrelli, M, Cantello, R, Nasuelli, N, Servo, S, De Gennaro, R, Gastaldo, E, Georgoulopoulou, E, Fini, N, Taiello, Ac, Colletti, T, Calvo, A, Moglia, C, Fuda, G, Marinou, K, Riva, N, Cerri, F, Lopez, Id, De Cicco, D, Battaglia, G, Marcello, N, Rinaldi, M, Scialò, C, Mantero, V, Mascolo, M, Carlesi, C, Caldarazzo Ienco, E, Di Muzio, A, Verriello, L, D'Amico, D, Simone, Il, Tortelli, R, Cortese, R, Bartolomei, I, G., Lauria, E., Dalla Bella, G., Antonini, G., Borghero, M., Capasso, C., Caponnetto, A., Chiò, M., Corbo, R., Eleopra, R., Fazio, M., Filosto, F., Giannini, E., Granieri, V., La Bella, G., Logroscino, J., Mandrioli, L., Mazzini, Monsurro', Maria Rosaria, G., Mora, V., Pietrini, R, Quatrale, R., Rizzi, F., Salvi, G., Siciliano, G., Sorarù, P., Volanti, I., Tramacere, G., Filippini, on behalf of the EPOS Trial Study, Group, Lauria, G., Bella, E. D., Antonini, G., Borghero, G., Capasso, M., Caponnetto, C., Chio, A., Corbo, M., Eleopra, R., Fazio, R., Filosto, M., Giannini, F., Granieri, E., Bella, V. L., Logroscino, G., Mandrioli, J., Mazzini, L., Mora, G., Pietrini, V., Quatrale, R., Rizzi, R., Salvi, F., Siciliano, G., Soraru, G., Volanti, P., Tramacere, I., Filippini, G., Lauria, G, Dalla Bella, Eleonora, Antonini, G, Borghero, G, Capasso, M, Caponnetto, C, Chiò, A, Corbo, M, Eleopra, R, Fazio, R, Filosto, M, Giannini, F, Granieri, E, LA BELLA, V, Logroscino, G, Mandrioli, J, Mazzini, L, Monsurrò, Maria Rosaria, Mora, G, Pietrini, V, Quatrale, R, Rizzi, R, Salvi, F, Siciliano, G, Sorarù, G, Volanti, P, and Tramacere Irene, Filippini, G.

Subjects
Male, Gastroenterology, law.invention, Randomized controlled trial, law, Amyotrophic lateral sclerosis, MOTOR NEURON DISEASE, education.field_of_study, Recombinant Protein, Middle Aged, Recombinant Proteins, Treatment Outcome, Psychiatry and Mental Health, Neuromuscular, Settore MED/26 - Neurologia, Female, erythropoietyn, clinical trial, medicine.drug, Human, ALS, Adult, Aged, Amyotrophic Lateral Sclerosis, Double-Blind Method, Erythropoietin, Humans, medicine.medical_specialty, Population, Socio-culturale, Placebo, Double blind, Arts and Humanities (miscellaneous), Epoetin Alfa, Neurology (clinical), Surgery, Internal medicine, medicine, education, business.industry, Epoetin alfa, medicine.disease, Clinical trial, business, Amyotrophic Lateral Sclerosi
Abstract

Objective To assess the efficacy of recombinant human erythropoietin (rhEPO) in amyotrophic lateral sclerosis (ALS). Methods Patients with probable laboratory-supported, probable or definite ALS were enrolled by 25 Italian centres and randomly assigned (1:1) to receive intravenous rhEPO 40 000 IU or placebo fortnightly as add-on treatment to riluzole 100 mg daily for 12 months. The primary composite outcome was survival, tracheotomy or >23 h non-invasive ventilation (NIV). Secondary outcomes were ALSFRS-R, slow vital capacity (sVC) and quality of life (ALSAQ-40) decline. Tolerability was evaluated analysing adverse events (AEs) causing withdrawal. The randomisation sequence was computer-generated by blocks, stratified by centre, disease severity (ALSFRS-R cut-off score of 33) and onset (spinal or bulbar). The main outcome analysis was performed in all randomised patients and by intentionto-treat for the entire population and patients stratified by severity and onset. The study is registered, EudraCT 2009-016066-91. Results We randomly assigned 208 patients, of whom 5 (1 rhEPO and 4 placebo) withdrew consent and 3 ( placebo) became ineligible (retinal thrombosis, respiratory insufficiency, SOD1 mutation) before receiving treatment; 103 receiving rhEPO and 97 placebo were eligible for analysis. At 12 months, the annualised rate of death (rhEPO 0.11, 95% CI 0.06 to 0.20; placebo: 0.08, CI 0.04 to 0.17), tracheotomy or >23 h NIV (rhEPO 0.16, CI 0.10 to 0.27; placebo 0.18, CI 0.11 to 0.30) did not differ between groups, also after stratification by onset and ALSFRS-R at baseline. Withdrawal due to AE was 16.5% in rhEPO and 8.3% in placebo. No differences were found for secondary outcomes. Conclusions RhEPO 40 000 IU fortnightly did not change the course of ALS.

14. The PRIAMO study: age- and sex-related relationship between prodromal constipation and disease phenotype in early Parkinson’s disease

Author

L Grasso, Silvia Ramat, Simone Gallerini, Paolo Barone, G. Di Brigida, D. Fogli, Tommaso Scaravilli, M. Braga, Alessandra Nicoletti, M. Romeno, Paolo Martinelli, G. Gurgone, Cesare Colosimo, E. Pilleri, V. Sorbello, S. Amidei, F. Pennisi, Francesco Iemolo, Giorgio Trianni, Vincenzo Toni, E. Milan, Raffaele Palladino, D. Benincasa, Giovanni Pezzoli, M. G. Randisi, Alfredo Petrone, Arianna Guidubaldi, R. Alfano, Tania P. Avarello, A. Scaglioni, Anna Rita Bentivoglio, C. Modica, L. Ferigo, M. Manfredi, Domenico Consoli, Giuseppe Meco, Giampiero Volpe, S. Griffini, Francesca Morgante, R. Scala, G. Nordera, Angelo Antonini, G. Floris, Roberto Erro, R. Muoio, Salvatore Zappulla, Luigi Bartolomei, Edo Bottacchi, Antonio Pisani, V. Petretta, Giovanni Fabbrini, G. Ciacci, L. Maiello, G. Ceravolo, M. Di Giovanni, V. Nastasi, Rocco Quatrale, D. Tiple, Marcello Deriu, S. Lanfranchi, Marianna Capecci, Alberto Albanese, T. Cuomo, Francesco E. Pontieri, Vincenzo Moschella, G. Sciortino, F. A. De Falco, S. Biguzzi, Leonardo Lopiano, Marina Picillo, C. Alesi, D. De Gaspari, Michele Abrignani, Gabriella Santangelo, Fabrizio Stocchi, R. Luciano, M. Baratti, R. M. Giglia, Cesa Scaglione, B. Troianiello, Giovanni Abbruzzese, M. Mucchiut, F. Pepe, S. Zanini, L. Capus, N. Caravona, Giovanni Cossu, V. Agnetti, G. Albani, L. Kiferle, E. Giaccaglini, Roberto Marconi, M. Iellamo, R. Marano, D. Medici, Monica Ulivelli, G. A. Cocco, M. Perini, P. Del Dotto, Rosa M. Gaglio, Rodolfo Savica, C. Logi, G. Ciccarelli, P. Massimo, M. Pesare, Antonino Cannas, Roberto Ceravolo, P. Simone, Letterio Morgante, P. Soliveri, S. Meoni, Picillo, M., Palladino, R., Erro, R., Alfano, R., Colosimo, C., Marconi, R., Antonini, A., Barone, P., Morgante, L., Benincasa, D., Quatrale, R., Biguzzi, S., Braga, M., Ceravolo, G., Capecci, M., Meco, G., Caravona, N., Scala, R., De Falco, F. A., Pezzoli, G., De Gaspari, D., Bottacchi, E., Di Giovanni, M., Cannas, A., Floris, G., Gallerini, S., Grasso, L., Gaglio, R. M., Gurgone, G., Volpe, G., Zappulla, S., Ceravolo, R., Kiferle, L., Ramat, S., Meoni, S., Pisani, A., Moschella, V., Morgante, F., Savica, R., Pepe, F., Ciccarelli, G., Petretta, V., Giglia, R. M., Randisi, M. G., Iemolo, F., Avarello, T. P., Romeno, M., Santangelo, G., Stocchi, F., Sciortino, G., Sorbello, V., Nicoletti, A., Tiple, D., Fabbrini, G., Bentivoglio, A., Pontieri, F. E., Guidubaldi, A., Muoio, R., Toni, V., Del Dotto, P., Logi, C., Ciacci, G., Ulivelli, M., Perini, M., Lanfranchi, S., Griffini, S., Troianiello, B., Baratti, M., Amidei, S., Consoli, D., Iellamo, M., Cuomo, T., Scaglioni, A., Medici, D., Manfredi, M., Abbruzzese, G., Di Brigida, G., Cocco, G. A., Agnetti, V., Cossu, G., Deriu, M., Abrignani, M., Modica, C., Albani, G., Milan, E., Martinelli, P., Scaglione, C., Mucchiut, M., Zanini, S., Pennisi, F., Soliveri, P., Albanese, A., Massimo, P., Bartolomei, L., Capus, L., Ferigo, L., Marano, R., Nastasi, V., Luciano, R., Maiello, L., Simone, P., Fogli, D., Lopiano, L., Pesare, M., Nordera, G., Pilleri, E., Scaravilli, T., Giaccaglini, E., Alesi, C., Petrone, A., and Trianni, G.

Subjects
Male, Neurology, Parkinson's disease, Constipation, Heterogeneity, Parkinson, Phenotype, Prodromal, Sex, PROGRESSION, Disease, 0302 clinical medicine, Apathy, Neuroradiology, Original Communication, Cognition, Parkinson Disease, 030211 gastroenterology & hepatology, Female, medicine.symptom, NONMOTOR SYMPTOMS, Life Sciences & Biomedicine, PRIAMO study group, Human, medicine.medical_specialty, Clinical Neurology, Prodromal Symptoms, Prodromal Symptom, 03 medical and health sciences, Internal medicine, medicine, Humans, Clinical phenotype, Aged, Science & Technology, Neurology & Neurosurgery, business.industry, 1103 Clinical Sciences, Biomarker, medicine.disease, DYSFUNCTION, Biomarkers, Neurology (clinical), Neurosciences & Neurology, business, 1109 Neurosciences, 030217 neurology & neurosurgery
Abstract

Objectives To explore the impact of sex and age on relationship between prodromal constipation and disease phenotype in Parkinson’s disease at early stages. Methods A total of 385 Parkinson’s disease patients from the PRIAMO study were classified according to the presence of prodromal constipation and followed for 24 months. Multivariable mixed-effect models were applied. All analyses were performed separately for sex (64.1% men) and median age (different by sex: 67 years-old in men and 68 years-old in women). Results As for sex, prodromal constipation was associated with greater odds of attention/memory complaints and apathy symptoms in women only. As for age, prodromal constipation was associated with lower cognitive and higher apathy scores in older patients only. Conclusions Prodromal constipation anticipates lower cognitive performances and more severe apathy since the earliest stages in women and older patients. Sex- and age-related heterogeneity of prodromal markers of Parkinson’s disease may impact disease phenotype.

Published
2021

15. Caregiver burden and its related factors in advanced Parkinson's disease: data from the PREDICT study

Author

Leonardo Lopiano, Paolo Solla, Mariachiara Sensi, Giovanni Defazio, Rocco Quatrale, Nicola Tambasco, Anna Maria Costanzo, Pietro Marano, Angelo Antonini, Umberto di Luzio Paparatti, Francesco E. Pontieri, Nicola Modugno, Alessandro Tessitore, Gabriella Melzi, Margherita Canesi, Giuliana Gualberti, Anna Latorre, Tessitore, A., Marano, P., Modugno, N., Pontieri, F. E., Tambasco, N., Canesi, M., Latorre, A., Lopiano, L., Sensi, M., Quatrale, R., Solla, P., Defazio, G., Melzi, G., Costanzo, A. M., Gualberti, G., di Luzio Paparatti, U., and Antonini, A.

Subjects
Male, Neurology, Parkinson's disease, Apomorphine, Cross-sectional study, Socioeconomic Factor, Antiparkinson Agents, Levodopa, 0302 clinical medicine, Quality of life, Cost of Illness, Drug Combination, advanced parkinson’s disease, Surveys and Questionnaires, 80 and over, Surveys and Questionnaire, 030212 general & internal medicine, Aged, 80 and over, Advanced Parkinson’s disease, Caregiver burden, Intestinal infusion, Levodopa/carbidopa, Neurology (clinical), Carbidopa, Parkinson Disease, Middle Aged, 3. Good health, Distress, Drug Combinations, Treatment Outcome, Caregivers, Italy, Patient Satisfaction, Antiparkinson Agent, Female, medicine.drug, Human, medicine.medical_specialty, Aged, Cross-Sectional Studies, Family, Humans, Quality of Life, Socioeconomic Factors, levodopa/carbidopa, 03 medical and health sciences, Patient satisfaction, medicine, Cross-Sectional Studie, caregiver burden, business.industry, intestinal infusion, quality of life, Correction, medicine.disease, Caregiver, Physical therapy, business, 030217 neurology & neurosurgery
Abstract

Introduction: Caring for a person with Parkinson’s disease (PD) is associated with an increased risk of psychiatric morbidity and persistent distress. The objective of this study was to describe the burden and the related factors of caregivers of advanced PD (APD) patients either treated with continuous dopaminergic delivery systems or standard therapy. Methods: This cross-sectional, epidemiologic study conducted in 13 Italian sites enrolled PD patients treated with continuous dopaminergic delivering systems [either levodopa/carbidopa intestinal gel (LCIG) infusion or continuous subcutaneous apomorphine infusion (CSAI)] or continuation of standard of care (SOC) with a caregiver. Patient quality of life (QoL) and caregiver burden were assessed using the Parkinson’s Disease Questionnaire (PDQ-8) and Zarit Burden Inventory (ZBI), respectively. Results: 126 patients (mean age 69.3 ± 8years) and their caregivers (mean age 57.9 ± 12.9) were enrolled. Most caregivers were spouses. Fifty-three patients were treated with LCIG, 19 with CSAI, and 54 with SOC. Mean ZBI scores were 29.6 ± 14.4 for LCIG, 35.8 ± 20.2 for CSAI, and 31.4 ± 16.0 for SOC. Caregivers of LCIG, CSAI, and SOC patients showed no burden or mild/moderate burden in 74, 53, and 63% of the cases, respectively. Mean PDQ-8 scores were 11.25 ± 5.67, 11.26 ± 5.55, and 14.22 ± 6.51 in LCIG, CSAI, and SOC patients. Neurologists considered patients “very much or much improved” in 89, 58, and 13% of the LCIG, CSAI, and SOC groups using the Clinical Global Impression–Global Improvement Scale. Predictors significantly associated with caregiver burden were patients and caregivers’ judgment of QoL and caregivers’ need to change work. Conclusions: Caregiver burden showed a tendency to be lower when patients are treated with LCIG than with CSAI or SOC.

Published
2017

16. Brain interstitial nociceptin/orphanin FQ levels are elevated in Parkinson's disease

Author

Patrizia Romualdi, Michele Simonato, Sara Biguzzi, Silvio Sarubbo, Roberto Eleopra, Matteo Marti, Carlo Conti, Sanzio Candeletti, Christian Lettieri, Michele Alessandro Cavallo, Rocco Quatrale, Francesco Latini, Mariachiara Sensi, Michele Morari, Silvia Zucchini, Marti M, Sarubbo S, Latini F, Cavallo M, Eleopra R, Biguzzi S, Lettieri C, Conti C, Simonato M, Zucchini S, Quatrale R, Sensi M, Candeletti S, Romualdi P, and Morari M.

Subjects
Adult, Male, medicine.medical_specialty, Parkinson's disease, Microdialysis, Substantia nigra, Rats, Sprague-Dawley, Young Adult, CEREBROSPINAL FLUID, Adrenergic Agents, Dopamine, Internal medicine, medicine, Haloperidol, Animals, Humans, Oxidopamine, Aged, Aged, 80 and over, Analysis of Variance, Behavior, Animal, business.industry, Parkinsonism, Brain, HUMAN, Parkinson Disease, MICRODYALISIS, Middle Aged, medicine.disease, NOCICEPTIN, Rats, nervous system diseases, Nociceptin receptor, Subthalamic nucleus, Disease Models, Animal, Endocrinology, Globus pallidus, Neurology, Gene Expression Regulation, Opioid Peptides, nervous system, Female, Neurology (clinical), business, PARKINSON'S DISEASE, medicine.drug, Antipsychotic Agents
Abstract

Expression and release of nociceptin/orphanin FQ (N/OFQ) are elevated in the substantia nigra reticulata of 6- hydroxydopamine-hemilesioned rats, suggesting a pathogenic role for N/OFQ in Parkinson's disease. In this study, we investigated whether elevation of N/OFQ expression in 6-hy- droxydopamine-hemilesioned rats selectively occurs in sub- stantia nigra and whether hypomotility following acute halo- peridol administration is accompanied by a rise in nigral N/ OFQ levels. Moreover, to prove a link between N/OFQ and idiopathic Parkinson's disease in humans, we measured N/ OFQ levels in the cerebrospinal fluid of parkinsonian patients undergoing surgery for deep brain stimulation. In situ hybrid- ization demonstrated that dopamine depletion was associated with increase of N/OFQ expression in substantia nigra (com- pacta 1160%, reticulata 1105%) and subthalamic nucleus (145%), as well as reduction in caudate putamen (220%). No change was observed in globus pallidus, nucleus accum- bens, thalamus, and motor cortex. Microdialysis coupled to the bar test allowed to demonstrate that acute administration of haloperidol (0.8 and 3 mg/kg) increased nigral N/OFQ lev- els (maximally of 147% and 153%, respectively) in parallel with akinesia. A correlation with preclinical studies was found by analyzing N/OFQ levels in humans. Indeed, N/OFQ levels were found to be 3.5-fold elevated in the cerebrospi- nal fluid of parkinsonian patients (148 fmol/ml) compared with nonparkinsonian neurologic controls (41 fmol/ml). These data represent the first clinical evidence linking N/ OFQ to idiopathic Parkinson's disease in humans. They strengthen the pathogenic role of N/OFQ in the modulation of parkinsonism across species and provide a rationale for developing N/OFQ receptor antagonists as antiparkinsonian drugs. 2010 Movement Disorder Society

Published
2010

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