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1. The Italian dementia with Lewy bodies study group (DLB-SINdem): toward a standardization of clinical procedures and multicenter cohort studies design

Author

Bonanni, L, Cagnin, A., Agosta, F., Babiloni, C., Borroni, B., Bozzali, M., Bruni, A. C., Filippi, M., Galimberti, D., Monastero, R., Muscio, C., Parnetti, L., Perani, D., Serra, L., Silani, V., Tiraboschi, P., Padovani, A., On behalf of DLB SINdem study group, Null, Alberici, A., Alberoni, M., Amici, S., Appollonio, I., Arena, M. G., Arighi, A., Avanzi, S., Bagella, C. F., Baglio, F., Barocco, F., Belardinelli, N., Bonuccelli, U., Bottini, G., Bruno Bossio, R., Bruno, G., Buccomino, D., Cacchiò, G., Calabrese, E., Campanelli, A., Canevelli, M., Canu, E. D. G., Cappa, A., Capra, C., Carapelle, E., Caratozzolo, S., Carbone, G. F. S., Cattaruzza, T., Cerami, C., Cester, A., Cheldi, A., Cherchi, R., Chiari, A., Cirafisi, C., Colao, R., Confaloni, A., Conti, M. Z., Costa, A., Costa, B., Cotelli, M. S., Cova, I., Cravello, L., Cumbo, E., Cupidi, C., De Togni, L., Del Din, G., Del Re, M. L., Dentizzi, C., Di Lorenzo, F., Di Stefano, F., Dikova, N., Farina, E., Floris, G., Foti, A., Franceschi, M., Fumagalli, G. G., Gabelli, C., Ghidoni, E., Giannandrea, D., Giordana, M. T., Giorelli, M., Giubilei, F., Grimaldi, L., Grimaldi, R., Guglielmi, V., Lanari, A., Le Pira, F., Letteri, F., Levi Minzi, G. V., Lorusso, S., Ludovico, L., Luzzi, S., Maggiore, L., Magnani, G., Mancini, G., Manconi, F. M., Manfredi, L., Maniscalco, M., Marano, P., Marcon, M., Marcone, A., Marra, C., Martorana, A., Mascia, M. G., Mascia, V., Mauri, M., Mazzei, B., Meloni, M., Merlo, P., Messa, G., Milia, A., Monacelli, F., Montecalvo, G., Moschella, V., Mura, G., Nemni, R., Nobili, F., Notarelli, A., Di Giacomo, R., Onofrj, M., Paci, C., Padiglioni, C., Perini, M., Perotta, D., Perri, Formenti A., Perri, R., Piccininni, C., Piccoli, T., Pilia, G., Pilotto, A., Poli, S., Pomati, S., Pompanin, S., Pucci, E., Puccio, G., Quaranta, D., Rainero, I., Rea, G., Realmuto, S., Riva, M., Rizzetti, M. C., Rolma, G., Rozzini, L., Sacco, L., Saibene, F. L., Scarpini, E., Sensi, S., Seripa, D., Sinforiani, E., Sorbi, S., Sorrentino, Giuseppe, Spallazzi, M., Stracciari, A., Talarico, G., Tassinari, T., Thomas, A., Tiezzi, A., Tomassini, P. F., Trebbastoni, A., Tremolizzo, L., Tripi, G., Ursini, F., Vaianella, L., Valluzzi, F., Vezzadini, G., Vista, M., Volontè, M. A., Bonanni, L, Cagnin, A, Agosta, F, Babiloni, C, Borroni, B, Bozzali, M, Bruni, A, Filippi, M, Galimberti, D, Monastero, R, Muscio, C, Parnetti, L, Perani, D, Serra, L, Silani, V, Tiraboschi, P, Padovani, A, Alberici, A, Alberoni, M, Amici, S, Appollonio, I, Arena, M, Arighi, A, Avanzi, S, Bagella, C, Baglio, F, Barocco, F, Belardinelli, N, Bonuccelli, U, Bottini, G, Bruno Bossio, R, Bruno, G, Buccomino, D, Cacchiò, G, Calabrese, E, Campanelli, A, Canevelli, M, Canu, E, Cappa, A, Capra, C, Carapelle, E, Caratozzolo, S, Carbone, G, Cattaruzza, T, Cerami, C, Cester, A, Cheldi, A, Cherchi, R, Chiari, A, Cirafisi, C, Colao, R, Confaloni, A, Conti, M, Costa, A, Costa, B, Cotelli, M, Cova, I, Cravello, L, Cumbo, E, Cupidi, C, de Togni, L, Del Din, G, Del Re, M, Dentizzi, C, Di Lorenzo, F, Di Stefano, F, Dikova, N, Farina, E, Floris, G, Foti, A, Franceschi, M, Fumagalli, G, Gabelli, C, Ghidoni, E, Giannandrea, D, Giordana, M, Giorelli, M, Giubilei, F, Grimaldi, L, Grimaldi, R, Guglielmi, V, Lanari, A, Le Pira, F, Letteri, F, Levi Minzi, G, Lorusso, S, Ludovico, L, Luzzi, S, Maggiore, L, Magnani, G, Mancini, G, Manconi, F, Manfredi, L, Maniscalco, M, Marano, P, Marcon, M, Marcone, A, Marra, C, Martorana, A, Mascia, M, Mascia, V, Mauri, M, Mazzei, B, Meloni, M, Merlo, P, Messa, G, Milia, A, Monacelli, F, Montecalvo, G, Moschella, V, Mura, G, Nemni, R, Nobili, F, Notarelli, A, Di Giacomo, R, Onofrj, M, Paci, C, Padiglioni, C, Perini, M, Perotta, D, Perri, F, Perri, R, Piccininni, C, Piccoli, T, Pilia, G, Pilotto, A, Poli, S, Pomati, S, Pompanin, S, Pucci, E, Puccio, G, Quaranta, D, Rainero, I, Rea, G, Realmuto, S, Riva, M, Rizzetti, M, Rolma, G, Rozzini, L, Sacco, L, Saibene, F, Scarpini, E, Sensi, S, Seripa, D, Sinforiani, E, Sorbi, S, Sorrentino, G, Spallazzi, M, Stracciari, A, Talarico, G, Tassinari, T, Thomas, A, Tiezzi, A, Tomassini, P, Trebbastoni, A, Tremolizzo, L, Tripi, G, Ursini, F, Vaianella, L, Valluzzi, F, Vezzadini, G, Vista, M, Volontè, M, Bruni, Ac, DLB-SINdem study, Group, Bruni, AC, and Padovani, A - On behalf of DLB-SINdem study group

Subjects
Lewy Body Disease, medicine.medical_specialty, Pediatrics, Dementia with Lewy bodie, Dementia with Lewy bodies, Dermatology, Cohort Studies, Diagnosis, Differential, 03 medical and health sciences, 0302 clinical medicine, Quality of life, Alzheimer Disease, Surveys and Questionnaires, mental disorders, Standardization of diagnostic procedures, Diagnosis, Survey, Disease Management, Humans, Italy, Research Design, 2708, Neurology (clinical), Psychiatry and Mental Health, medicine, Dementia, 030212 general & internal medicine, MED/01 - STATISTICA MEDICA, MED/26 - NEUROLOGIA, business.industry, Standardization of diagnostic procedure, General Medicine, medicine.disease, Settore MED/26 - NEUROLOGIA, Cohort, Differential, Physical therapy, Delirium, Alzheimer's disease, medicine.symptom, business, 030217 neurology & neurosurgery, Frontotemporal dementia, Cohort study
Abstract

Dementia with Lewy bodies (DLB) causes elevated outlays for the National Health Systems due to high institutionalization rate and patients' reduced quality of life and high mortality. Furthermore, DLB is often misdiagnosed as Alzheimer's disease. These data motivate harmonized multicenter longitudinal cohort studies to improve clinical management and therapy monitoring. The Italian DLB study group of the Italian Neurological Society for dementia (SINdem) developed and emailed a semi-structured questionnaire to 572 national dementia centers (from primary to tertiary) to prepare an Italian large longitudinal cohort. The questionnaire surveyed: (1) prevalence and incidence of DLB; (2) clinical assessment; (3) relevance and availability of diagnostic tools; (4) pharmacological management of cognitive, motor, and behavioural disturbances; (5) causes of hospitalization, with specific focus on delirium and its treatment. Overall, 135 centers (23.6 %) contributed to the survey. Overall, 5624 patients with DLB are currently followed by the 135 centers in a year (2042 of them are new patients). The percentage of DLB patients was lower (27 ± 8 %) than that of Alzheimer's disease and frontotemporal dementia (56 ± 27 %) patients. The majority of the centers (91 %) considered the clinical and neuropsychological assessments as the most relevant procedure for a DLB diagnosis. Nonetheless, most of the centers has availability of magnetic resonance imaging (MRI; 95 %), electroencephalography (EEG; 93 %), and FP-CIT single photon emission-computerized tomography (SPECT; 75 %) scan for clinical applications. It will be, therefore, possible to recruit a large harmonized Italian cohort of DLB patients for future cross-sectional and longitudinal multicenter studies.

Published
2017

2. Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study

Author

Clerici F, Vanacore N, Elia A, Spila Alegiani S, Pomati S, Da Cas R, Raschetti R, Mariani C, Memantine Lombardy Study Group, Altavilla, R, APPOLLONIO, ILDEBRANDO, ISELLA, VALERIA, Avanzi, S, Bargnani, C, Bascelli, C, BELLELLI, GIUSEPPE, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, PL, Magnani, G, Schiatti, E, Marcone, A, Giusti, MC, Margarito, FP, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, CN, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, GP, Manzoni, L, Saviotti, FM, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati S, D, Raschetti, R, Mariani, C, Memantine Lombardy Study, G, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petro, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, and Alberici, A

Subjects
Male, medicine.medical_specialty, Postmarketing surveillance, Severity of Illness Index, law.invention, Demenza, malattia di Alzheimer, Randomized controlled trial, law, Alzheimer Disease, Memantine, Internal medicine, medicine, Product Surveillance, Postmarketing, Dementia, Humans, Pharmacology (medical), Adverse effect, Aged, MED/26 - NEUROLOGIA, Aged, 80 and over, Psychiatric Status Rating Scales, business.industry, Odds ratio, medicine.disease, Surgery, Treatment Outcome, Tolerability, Italy, Clinical Global Impression, Female, Geriatrics and Gerontology, business, Excitatory Amino Acid Antagonists, memantina, medicine.drug
Abstract

Background: Postmarketing surveillance studies (PMS) are an important tool for evaluating a drug’s effectiveness and safety in clinical practice. To our knowledge, no PMS on memantine monotherapy for moderately-severe-to-severe Alzheimer’s disease (AD) according to National Institute of Neurological and Communicative Disorders and Stroke — Alzheimer’s Disease and Related Disorders Association criteria has been conducted to date. Objective: The Lombardy Health Office, Italy, promoted this PMS to evaluate the effectiveness and safety of memantine in the treatment of moderately-severe-to-severe AD in clinical practice. Methods: A total of 451 patients with moderately-severe-to-severe AD (mean age 77 ± 7 years; 72% female), free of cholinergic medication, received memantine (standard titration to 10 mg twice daily). After 6 months of therapy, treatment effectiveness was evaluated according to two definitions of response (‘no deterioration’ and ‘improvement’), as measured by changes in baseline scores on the Clinical Global Impression of Change, Mini-Mental State Examination, Neuropsychiatric Inventory and Activities of Daily Living scales. The safety measure was the frequency of adverse events (AEs). Results: At 6-month assessment, 26.8% of subjects showed no deterioration and 3.8% showed improvement. In those showing no deterioration, response to treatment at the 3-month assessment was associated with a greater probability of a response at 6 months (adjusted odds ratio = 8.54; 95% CI 4.54, 16.05). Seventy patients (15.5%) experienced at least one AE and 39 (8.6%) discontinued treatment prematurely because of an AE. Of those who experienced an AE, 27 (38.6%) manifested behavioural and psychological symptoms of dementia. Conclusion: The proportion of responders to memantine treatment in this PMS was similar to that reported in a previous randomized clinical trial (26.8% vs 29%, respectively). The proportion of patients who discontinued treatment prematurely because of an AE (8.6%) was similar to that reported in two previous randomized clinical trials (10% and 12.4%). This PMS provides additional evidence that both the effectiveness and the tolerability of memantine may be transferred into real world medicine, where AD patients receiving treatment are not selected according to strict criteria.

Published
2009

3. Memantine effects on behaviour in moderately severe to severe Alzheimer's disease: a post-marketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila-Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, Pl, Magnani, G, Schiatti, E, Marcone, A, Giusti, Mc, Margarito, Fp, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Negri Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petrò, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, Gp, Manzoni, L, Saviotti, Fm, Scarpini, E, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, Alberici, A., Clerici, F, Vanacore, N, Elia, A, Spila Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Marcon, Gabriella, and Appollonio, I

Subjects
Male, medicine.medical_specialty, Psychosis, Hallucinations, Behavioural and psychological symptoms of dementia, Apathy, Dopamine Agents, Postmarketing surveillance, Dermatology, Anxiety, Neuropsychological Tests, Logistic regression, Disease cluster, Severity of Illness Index, Alzheimer's disease, Memantine, Post-marketing surveillance study, Alzheimer Disease, Internal medicine, Severity of illness, Product Surveillance, Postmarketing, medicine, Humans, Dementia, Psychiatry, BIO/14 - FARMACOLOGIA, Aged, Aged, 80 and over, MED/26 - NEUROLOGIA, treatment, Depression, Feeding Behavior, General Medicine, medicine.disease, Psychiatry and Mental health, Treatment Outcome, Hypomania, Female, Neurology (clinical), medicine.symptom, Psychology, Follow-Up Studies, dementia, medicine.drug
Abstract

The aim of this study is to evaluate memantine effectiveness on behavioural and psychological symptoms of dementia (BPSD) in clinical practice and to identify variables that may predict the therapy effects. The effects of memantine on behaviour were analysed in the database of a post-marketing surveillance study promoted by the Lombardy Region Health Office and involving 43 Alzheimer's disease (AD) Units. From July to December 2005, 399 moderately severe-to-severe AD patients free of cholinergic medications were enrolled, treated with memantine and followed-up for 6 months. BPSD were assessed in a subgroup of 297 patients [mean age 77 ± 8 years; 73% females; mean neuropsychiatric inventory (NPI) score 28 ± 24] for whom the 12-item NPI subscores at baseline, and at 3 and 6 months were available. The 12 BPSD were clustered as follows: affect, physical behaviour, psychosis and hypomania. The main outcome measure was the proportion of individual cluster responders at 6 months of therapy. The proportion of individual cluster responders was 30% affect, 24% physical behaviour, 29% psychosis, 27% hypomania. Patients taking 20 mg memantine daily during the study period had a statistically significant higher probability to experience behavioural improvement than those who discontinued treatment or did not complete memantine titration (affect OR 9.0; 95% CI 3.8-21.6; physical behaviour OR 17.8; 95% CI 5.9-53.6; psychosis OR 23.6; 95% CI 5.1-110.8). The logistic regression analysis was not applicable to the hypomania subsyndrome because of the low cluster prevalence. The standard 20 mg daily memantine treatment regimen was found to be associated with a modest 6-month behavioural improvement in the affect, physical behaviour and psychosis domains in 24-30% of patients.

Published
2012

4. Memantine in moderately-severe-to-severe Alzheimer's disease: a postmarketing surveillance study

Author

Clerici, F, Vanacore, N, Elia, A, Spila-Alegiani, S, Pomati, S, Da Cas, R, Raschetti, R, Mariani, C, Altavilla, R, Appollonio, I, Isella, V, Avanzi, S, Bargnani, C, Bascelli, C, Bellelli, G, Guerini, F, Belotti, G, Bottini, G, Gerini, M, Cheldi, A, Bellotti, M, Chia, F, Cislaghi, G, Cusi, C, Mesina, M, Cuzzoni, G, Farina, E, Alberoni, M, Franceschi, M, Zucchi, M, Guerini, M, Iori, T, Lanza, E, Finotti, M, Lucchelli, F, Maggiore, L, Ratti, P, Magnani, G, Schiatti, E, Marcone, A, Giusti, M, Margarito, F, Martina, A, Mauri, M, Merlo, P, Mazza, S, Moleri, M, Riva, R, Montecalvo, G, Negri Chinaglia, C, Engaddi, I, Perini, M, Carnicelli, A, Petrò, E, Pettenati, C, Perotta, D, Ranzenigo, A, Bertozzi, B, Redaelli, L, Reverberi, F, Salvi, G, Manzoni, L, Saviotti, F, Scarpini, E, Guidi, I, Sinforiani, E, Zucchella, C, Tagliavini, F, Marcon, G, Turla, M, Viti, N, Zanetti, O, and Alberici, A

Published
2009

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