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1. Gearing up for the future: Exploring facilitators and barriers to inform clinical trial design in frontotemporal lobar degeneration

Author

Banga, YB, Banga, YB, Lai, Y, Kim, P, Boeve, BF, Boxer, AL, Rosen, HJ, Forsberg, LK, Heuer, HW, Brushaber, D, Appleby, B, Biernacka, JM, Bordelon, YM, Botha, H, Bozoki, AC, Brannelly, P, Dickerson, BC, Dickinson, S, Dickson, DW, Domoto-Reilly, K, Faber, K, Fagan, AM, Fields, JA, Fishman, A, Foroud, TM, Galasko, DR, Gavrilova, RH, Gendron, TF, Geschwind, DH, Ghoshal, N, Goldman, J, Graff-Radford, J, Graff-Radford, NR, Grant, I, Grossman, M, Hsiung, GYR, Huang, EJ, Huey, ED, Irwin, DJ, Jones, DT, Kantarci, K, Karydas, AM, Kaufer, D, Knopman, DS, Kramer, JH, Kremers, WK, Kornak, J, Kukull, WA, Lagone, E, Leger, GC, Litvan, I, Ljubenkov, PA, Lucente, DE, Mackenzie, IR, Manoochehri, M, Masdeu, JC, McGinnis, S, Mendez, MF, Miller, BL, Miyagawa, T, Nelson, KM, Onyike, CU, Pantelyat, A, Pascual, B, Pearlman, R, Petrucelli, L, Pottier, CP, Rademakers, R, Ramos, EM, Rankin, KP, Rascovsky, K, Rexach, JE, Ritter, A, Roberson, ED, Rojas, JC, Sabbagh, MN, Salmon, DP, Savica, R, Seeley, WW, Staffaroni, AM, Syrjanen, JA, Tartaglia, MC, Tatton, N, Taylor, JC, Toga, AW, Weintraub, S, Wheaton, D, Wong, B, Wszolek, Z, Banga, YB, Banga, YB, Lai, Y, Kim, P, Boeve, BF, Boxer, AL, Rosen, HJ, Forsberg, LK, Heuer, HW, Brushaber, D, Appleby, B, Biernacka, JM, Bordelon, YM, Botha, H, Bozoki, AC, Brannelly, P, Dickerson, BC, Dickinson, S, Dickson, DW, Domoto-Reilly, K, Faber, K, Fagan, AM, Fields, JA, Fishman, A, Foroud, TM, Galasko, DR, Gavrilova, RH, Gendron, TF, Geschwind, DH, Ghoshal, N, Goldman, J, Graff-Radford, J, Graff-Radford, NR, Grant, I, Grossman, M, Hsiung, GYR, Huang, EJ, Huey, ED, Irwin, DJ, Jones, DT, Kantarci, K, Karydas, AM, Kaufer, D, Knopman, DS, Kramer, JH, Kremers, WK, Kornak, J, Kukull, WA, Lagone, E, Leger, GC, Litvan, I, Ljubenkov, PA, Lucente, DE, Mackenzie, IR, Manoochehri, M, Masdeu, JC, McGinnis, S, Mendez, MF, Miller, BL, Miyagawa, T, Nelson, KM, Onyike, CU, Pantelyat, A, Pascual, B, Pearlman, R, Petrucelli, L, Pottier, CP, Rademakers, R, Ramos, EM, Rankin, KP, Rascovsky, K, Rexach, JE, Ritter, A, Roberson, ED, Rojas, JC, Sabbagh, MN, Salmon, DP, Savica, R, Seeley, WW, Staffaroni, AM, Syrjanen, JA, Tartaglia, MC, Tatton, N, Taylor, JC, Toga, AW, Weintraub, S, Wheaton, D, Wong, B, and Wszolek, Z

Abstract

BACKGROUND: Frontotemporal lobar degeneration (FTLD) refers to a group of neurodegenerative conditions, affecting the frontal and/or temporal lobes. Ongoing research has provided insight into developing clinical trials for FTLD and key clinical measures such as structural MRI. To inform clinical trial design and optimize participation, it is imperative to explore facilitators and barriers for potential candidates. OBJECTIVE: The objective of this study is to explore facilitators and barriers to participating in future clinical trials for FTLD. METHODS: Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL) and Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects (LEFFTDS) are observational studies focused on characterizing FTLD syndromes in preparation for clinical trials. The 584 participants enrolled across 18 research sites in the United States and Canada completed a survey assessing interest in clinical trial participation. RESULTS: 29% of respondents self-reported as patients (63±10 years), 26% self-reported as caregivers answering on behalf of patients (65±10 years), and 45% self-reported as healthy but at risk for FTLD (48±14 years). Travel reimbursement was the most common factor reported to positively influence participation (≧66%), with the healthy but at risk group showing the strongest endorsement (83%). Cost and time involved in travel were possible barriers for about half of the patients (48%) and healthy but at risk respondents (53%). The respondents value receiving feedback on the study findings (≧80%) and being informed of their individual disease progression (≧75%). Particularly, keeping participation confidential was very important for the healthy but at risk group (62%). In regard to research assessments, most participants demonstrated a high interest in physical and neurological exams at a research center (≧87%) whereas only half were interested in doing more invasive procedures such as the lumbar puncture

Published
2021

2. Demographic and psychosocial factors associated with the decision to learn mutation status in familial frontotemporal dementia and the impact of disclosure on mood

Author

Bajorek, LP, Bajorek, LP, Kiekhofer, R, Hall, M, Taylor, J, Lucente, DE, Brushaber, D, Appleby, B, Coppolla, G, Bordelon, YM, Botha, H, Dickerson, BC, Dickson, DW, Domoto-Reilly, K, Fagan, AM, Fields, JA, Fong, JC, Foroud, TM, Forsberg, LK, Galasko, DR, Gavrilova, RH, Geschwind, DH, Ghoshal, N, Goldman, J, Graff-Radford, NR, Graff-Radford, J, Grant, I, Grossman, M, Heuer, HW, Hsiung, GYR, Huang, EJ, Huey, ED, Irwin, DJ, Jones, DT, Kantarci, K, Kornak, J, Kremers, WK, Lapid, MI, Leger, GC, Litvan, I, Ljubenkov, PA, Mackenzie, IR, Masdeu, JC, McMillan, C, Mendez, M, Miller, BL, Miyagawa, T, Onyike, CU, Pascual, B, Pedraza, O, Petrucelli, L, Rademakers, R, Ramos, EM, Rankin, KP, Rascovsky, K, Rexach, JE, Ritter, A, Roberson, ED, Savica, R, Rojas, JC, Seeley, WW, Tartaglia, MC, Toga, AW, Weintraub, S, Wong, B, Wszolek, Z, Vandevrede, L, Boeve, BF, Boxer, AL, Rosen, HJ, Staffaroni, AM, Bajorek, LP, Bajorek, LP, Kiekhofer, R, Hall, M, Taylor, J, Lucente, DE, Brushaber, D, Appleby, B, Coppolla, G, Bordelon, YM, Botha, H, Dickerson, BC, Dickson, DW, Domoto-Reilly, K, Fagan, AM, Fields, JA, Fong, JC, Foroud, TM, Forsberg, LK, Galasko, DR, Gavrilova, RH, Geschwind, DH, Ghoshal, N, Goldman, J, Graff-Radford, NR, Graff-Radford, J, Grant, I, Grossman, M, Heuer, HW, Hsiung, GYR, Huang, EJ, Huey, ED, Irwin, DJ, Jones, DT, Kantarci, K, Kornak, J, Kremers, WK, Lapid, MI, Leger, GC, Litvan, I, Ljubenkov, PA, Mackenzie, IR, Masdeu, JC, McMillan, C, Mendez, M, Miller, BL, Miyagawa, T, Onyike, CU, Pascual, B, Pedraza, O, Petrucelli, L, Rademakers, R, Ramos, EM, Rankin, KP, Rascovsky, K, Rexach, JE, Ritter, A, Roberson, ED, Savica, R, Rojas, JC, Seeley, WW, Tartaglia, MC, Toga, AW, Weintraub, S, Wong, B, Wszolek, Z, Vandevrede, L, Boeve, BF, Boxer, AL, Rosen, HJ, and Staffaroni, AM

Abstract

BACKGROUND: Up to 30% of frontotemporal dementia (FTD) cases are due to known pathogenic mutations (f-FTD). Little is known about the factors that predict who will choose to learn their results. Upcoming clinical trials in f-FTD may require disclosure prior to enrollment, even before symptom onset, and thus characterizing this sample is important. Furthermore, understanding the mood impacts of genetic disclosure may guide genetic counseling practice. METHOD: F-FTD participants (n=568) from families with a known pathogenic mutation (MAPT, C9orf72, GRN) were enrolled through the ARTFL/LEFFTDS Longitudinal FTD Study (ALLFTD) and provided the opportunity for disclosure. Independent-sample t-tests compared demographic and psychosocial factors between participants who did and did not receive their results. In participants who were asymptomatic at baseline and follow up (n=199,177 with follow-up), linear mixed effects modeling was used to investigate pre- to post-disclosure changes in the 15-item Geriatric Depression Scale (GDS). RESULT: Of participants from families with a known pathogenic genetic mutation, 47% received genetic disclosure. Of the asymptomatic subset (n=386), 36% know their mutation status. Of these asymptomatic learners, 46% received disclosure through the study, and the remainder learned their genetic status prior to study enrollment. None of the analyzed demographic or psychosocial factors (i.e., sex, age, education, having children) differed between learners and non-learners (p's > 0.05). In the longitudinal analysis of asymptomatic participants, learners showed a pre- to post-increase of 0.31 GDS points/year (95%CI: -0.08, 0.69, p = 0.12), whereas non-learners showed a slight decline (-0.15 points/year, 95%CI: -0.36, 0.06, p = 0.16). This difference between slopes was statistically significant (0.46, 95%CI: 0.02, 0.89, p=0.04) but represents a small clinical effect. In asymptomatic learners, slopes did not differ based on mutation status (0.28, 95%

Published
2021

3. Gearing up for the future: Exploring facilitators and barriers to inform clinical trial design in frontotemporal lobar degeneration

Author

Banga, YB, Banga, YB, Lai, Y, Kim, P, Boeve, BF, Boxer, AL, Rosen, HJ, Forsberg, LK, Heuer, HW, Brushaber, D, Appleby, B, Biernacka, JM, Bordelon, YM, Botha, H, Bozoki, AC, Brannelly, P, Dickerson, BC, Dickinson, S, Dickson, DW, Domoto-Reilly, K, Faber, K, Fagan, AM, Fields, JA, Fishman, A, Foroud, TM, Galasko, DR, Gavrilova, RH, Gendron, TF, Geschwind, DH, Ghoshal, N, Goldman, J, Graff-Radford, J, Graff-Radford, NR, Grant, I, Grossman, M, Hsiung, GYR, Huang, EJ, Huey, ED, Irwin, DJ, Jones, DT, Kantarci, K, Karydas, AM, Kaufer, D, Knopman, DS, Kramer, JH, Kremers, WK, Kornak, J, Kukull, WA, Lagone, E, Leger, GC, Litvan, I, Ljubenkov, PA, Lucente, DE, Mackenzie, IR, Manoochehri, M, Masdeu, JC, McGinnis, S, Mendez, MF, Miller, BL, Miyagawa, T, Nelson, KM, Onyike, CU, Pantelyat, A, Pascual, B, Pearlman, R, Petrucelli, L, Pottier, CP, Rademakers, R, Ramos, EM, Rankin, KP, Rascovsky, K, Rexach, JE, Ritter, A, Roberson, ED, Rojas, JC, Sabbagh, MN, Salmon, DP, Savica, R, Seeley, WW, Staffaroni, AM, Syrjanen, JA, Tartaglia, MC, Tatton, N, Taylor, JC, Toga, AW, Weintraub, S, Wheaton, D, Wong, B, Wszolek, Z, Banga, YB, Banga, YB, Lai, Y, Kim, P, Boeve, BF, Boxer, AL, Rosen, HJ, Forsberg, LK, Heuer, HW, Brushaber, D, Appleby, B, Biernacka, JM, Bordelon, YM, Botha, H, Bozoki, AC, Brannelly, P, Dickerson, BC, Dickinson, S, Dickson, DW, Domoto-Reilly, K, Faber, K, Fagan, AM, Fields, JA, Fishman, A, Foroud, TM, Galasko, DR, Gavrilova, RH, Gendron, TF, Geschwind, DH, Ghoshal, N, Goldman, J, Graff-Radford, J, Graff-Radford, NR, Grant, I, Grossman, M, Hsiung, GYR, Huang, EJ, Huey, ED, Irwin, DJ, Jones, DT, Kantarci, K, Karydas, AM, Kaufer, D, Knopman, DS, Kramer, JH, Kremers, WK, Kornak, J, Kukull, WA, Lagone, E, Leger, GC, Litvan, I, Ljubenkov, PA, Lucente, DE, Mackenzie, IR, Manoochehri, M, Masdeu, JC, McGinnis, S, Mendez, MF, Miller, BL, Miyagawa, T, Nelson, KM, Onyike, CU, Pantelyat, A, Pascual, B, Pearlman, R, Petrucelli, L, Pottier, CP, Rademakers, R, Ramos, EM, Rankin, KP, Rascovsky, K, Rexach, JE, Ritter, A, Roberson, ED, Rojas, JC, Sabbagh, MN, Salmon, DP, Savica, R, Seeley, WW, Staffaroni, AM, Syrjanen, JA, Tartaglia, MC, Tatton, N, Taylor, JC, Toga, AW, Weintraub, S, Wheaton, D, Wong, B, and Wszolek, Z

Abstract

BACKGROUND: Frontotemporal lobar degeneration (FTLD) refers to a group of neurodegenerative conditions, affecting the frontal and/or temporal lobes. Ongoing research has provided insight into developing clinical trials for FTLD and key clinical measures such as structural MRI. To inform clinical trial design and optimize participation, it is imperative to explore facilitators and barriers for potential candidates. OBJECTIVE: The objective of this study is to explore facilitators and barriers to participating in future clinical trials for FTLD. METHODS: Advancing Research and Treatment for Frontotemporal Lobar Degeneration (ARTFL) and Longitudinal Evaluation of Familial Frontotemporal Dementia Subjects (LEFFTDS) are observational studies focused on characterizing FTLD syndromes in preparation for clinical trials. The 584 participants enrolled across 18 research sites in the United States and Canada completed a survey assessing interest in clinical trial participation. RESULTS: 29% of respondents self-reported as patients (63±10 years), 26% self-reported as caregivers answering on behalf of patients (65±10 years), and 45% self-reported as healthy but at risk for FTLD (48±14 years). Travel reimbursement was the most common factor reported to positively influence participation (≧66%), with the healthy but at risk group showing the strongest endorsement (83%). Cost and time involved in travel were possible barriers for about half of the patients (48%) and healthy but at risk respondents (53%). The respondents value receiving feedback on the study findings (≧80%) and being informed of their individual disease progression (≧75%). Particularly, keeping participation confidential was very important for the healthy but at risk group (62%). In regard to research assessments, most participants demonstrated a high interest in physical and neurological exams at a research center (≧87%) whereas only half were interested in doing more invasive procedures such as the lumbar puncture

Published
2021

4. Brain volumetric deficits in MAPT mutation carriers: a multisite study

Author

Chu, SA, Flagan, TM, Staffaroni, AM, Jiskoot, Lize, Deng, J, Spina, S, Zhang, L, Sturm, VE, Yokoyama, JS, Seeley, WW, Papma, Janne, Geschwind, DH, Rosen, HJ, Boeve, BF, Boxer, AL, Heuer, HW, Forsberg, LK, Brushaber, DE, Grossman, M, Coppola, G, Dickerson, BC, Bordelon, YM, Faber, K, Feldman, HH, Fields, JA, Fong, JC, Foroud, T, Gavrilova, RH, Ghoshal, N, Graff-Radford, NR, Hsiung, GYR, Huey, ED, Irwin, DJ, Kantarci, K, Kaufer, DI, Karydas, AM, Knopman, DS, Kornak, J, Kramer, JH, Kukull, WA, Lapid, MI, Litvan, I, Mackenzie, IRA, Mendez, MF, Miller, BL, Onyike, CU, Pantelyat, AY, Rademakers, R, Ramos, E, Roberson, ED, Tartaglia, M, Tatton, NA, Toga, AW, Vetor, A, Weintraub, S, Wong, B, Wszolek, ZK, van Swieten, J.C., Lee, SE, Chu, SA, Flagan, TM, Staffaroni, AM, Jiskoot, Lize, Deng, J, Spina, S, Zhang, L, Sturm, VE, Yokoyama, JS, Seeley, WW, Papma, Janne, Geschwind, DH, Rosen, HJ, Boeve, BF, Boxer, AL, Heuer, HW, Forsberg, LK, Brushaber, DE, Grossman, M, Coppola, G, Dickerson, BC, Bordelon, YM, Faber, K, Feldman, HH, Fields, JA, Fong, JC, Foroud, T, Gavrilova, RH, Ghoshal, N, Graff-Radford, NR, Hsiung, GYR, Huey, ED, Irwin, DJ, Kantarci, K, Kaufer, DI, Karydas, AM, Knopman, DS, Kornak, J, Kramer, JH, Kukull, WA, Lapid, MI, Litvan, I, Mackenzie, IRA, Mendez, MF, Miller, BL, Onyike, CU, Pantelyat, AY, Rademakers, R, Ramos, E, Roberson, ED, Tartaglia, M, Tatton, NA, Toga, AW, Vetor, A, Weintraub, S, Wong, B, Wszolek, ZK, van Swieten, J.C., and Lee, SE

Abstract

Objective: MAPT mutations typically cause behavioral variant frontotemporal dementia with or without parkinsonism. Previous studies have shown that symptomatic MAPT mutation carriers have frontotemporal atrophy, yet studies have shown mixed results as to whether presymptomatic carriers have low gray matter volumes. To elucidate whether presymptomatic carriers have lower structural brain volumes within regions atrophied during the symptomatic phase, we studied a large cohort of MAPT mutation carriers using a voxelwise approach. Methods: We studied 22 symptomatic carriers (age 54.7 ± 9.1, 13 female) and 43 presymptomatic carriers (age 39.2 ± 10.4, 21 female). Symptomatic carriers’ clinical syndromes included: behavioral variant frontotemporal dementia (18), an amnestic dementia syndrome (2), Parkinson’s disease (1), and mild cognitive impairment (1). We performed voxel-based morphometry on T1 images and assessed brain volumetrics by clinical subgroup, age, and mutation subtype. Results: Symptomatic carriers showed gray matter atrophy in bilateral frontotemporal cortex, insula, and striatum, and white matter atrophy in bilateral corpus callosum and uncinate fasciculus. Approximately 20% of presymptomatic carriers had low gray matter volumes in bilateral hippocampus, amygdala, and lateral temporal cortex. Within these regions, low gray matter volumes emerged in a subset of presymptomatic carriers as early as their thirties. Low white matter volumes arose infrequently among presymptomatic carriers. Interpretation: A subset of presymptomatic MAPT mutation carriers showed low volumes in mesial temporal lobe, the region ubiquitously atrophied in all symptomatic carriers. With each decade of age, an increasing percentage of presymptomatic carriers showed low mesial temporal volume, suggestive of early neurodegeneration.

Published
2021

5. Minimal clinically important worsening on the progressive supranuclear Palsy Rating Scale

Author

Hewer, S, Varley, S, Boxer, AL, Paul, E, Williams, DR, Azulay, JP, Benecke, R, Boeve, BF, Bordelon, YM, Miller, B, Burn, DJ, Chan, D, Corvol, JC, Couratier, P, Dayalu, P, Doody, R, Driver-Dunkley, E, Ferrara, J, Golbe, LI, Graff-Radford, NR, Grimes, D, Grossman, M, Gunzler, S, Hillis, AE, Höglinger, G, Honig, L, Lang, A, Lees, A, Litvan, I, Isaacson, SH, Jankovic, J, Jog, MS, Kaufer, DI, Kumar, R, Lafontaine, AL, Leegwater-Kim, J, Lessig, S, Lew, MF, Lipp, A, Lobach, I, Lorenzl, SP, Ludolph, A, Marras, C, McGinnis, S, Mollenhauer, B, Pahwa, R, Panisset, M, Reichmann, H, Roberson, E, Santiago, A, Schneider, L, Tuite, P, Williams, D, Woitalla, D, Womack, KB, Xie, T, Zamrini, E, Zermansky, A, Zesiewicz, TA, Hewer, S, Varley, S, Boxer, AL, Paul, E, Williams, DR, Azulay, JP, Benecke, R, Boeve, BF, Bordelon, YM, Miller, B, Burn, DJ, Chan, D, Corvol, JC, Couratier, P, Dayalu, P, Doody, R, Driver-Dunkley, E, Ferrara, J, Golbe, LI, Graff-Radford, NR, Grimes, D, Grossman, M, Gunzler, S, Hillis, AE, Höglinger, G, Honig, L, Lang, A, Lees, A, Litvan, I, Isaacson, SH, Jankovic, J, Jog, MS, Kaufer, DI, Kumar, R, Lafontaine, AL, Leegwater-Kim, J, Lessig, S, Lew, MF, Lipp, A, Lobach, I, Lorenzl, SP, Ludolph, A, Marras, C, McGinnis, S, Mollenhauer, B, Pahwa, R, Panisset, M, Reichmann, H, Roberson, E, Santiago, A, Schneider, L, Tuite, P, Williams, D, Woitalla, D, Womack, KB, Xie, T, Zamrini, E, Zermansky, A, and Zesiewicz, TA

Abstract

© 2016 2016 International Parkinson and Movement Disorder Society Background: Despite the widespread use of the Progressive Supranuclear Palsy Rating Scale (PSPRS), it is not known what change in this scale is meaningful for patients. Methods: We analyzed data from a large clinical trial in PSP-Richardson's syndrome (AL-108-231) to calculate minimal clinically important worsening. This was defined as the difference in mean change of PSPRS in subjects rated “a little worse” and those rated “unchanged” on the Clinicians' Global Impression of Change Scale. A multivariate analysis using logistic regression assessed the relationship between clinical worsening, PSPRS, depression, and activities of daily living. Results: The minimal clinically important worsening on the PSPRS was 5.7 points, corresponding to the mean decline over 6 months in the trial. Changes in activities of daily living and PSPRS were significantly associated with clinical worsening. Conclusions: Clinically meaningful change is measurable on the PSPRS over 6 months. © 2016 International Parkinson and Movement Disorder Society.

Published
2016

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