Book contents
- Alzheimer’s Disease Drug Development
- Alzheimer’s Disease Drug Development
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Acknowledgments
- Section 1 Advancing Alzheimer’s Disease Therapies in a Collaborative Science Ecosystem
- Section 2 Non-clinical Assessment of Alzheimer’s Disease Candidate Drugs
- Section 3 Alzheimer’s Disease Clinical Trials
- 11 Phase 1 Trials in Alzheimer’s Disease Drug Development
- 12 The Importance of Phase 2 in Drug Development for Alzheimer’s Disease
- 13 Alzheimer’s Disease Drug Development in Pharmaceutical Companies
- 14 Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development
- 15 ATRI and ACTC: Academic Programs to Accelerate Alzheimer’s Disease Drug Development
- 16 The European Prevention of Alzheimer’s Disease Program: A Public–Private Partnership to Facilitate the Secondary Prevention of Alzheimer’s Disease Dementia
- 17 The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials
- 18 Clinical Trial Development in Frontotemporal Lobar Degeneration
- 19 Statistical Considerations in the Design and Analysis of Alzheimer’s Disease Clinical Trials
- 20 Alzheimer’s Disease Trial Recruitment and Diversifying Trial Populations
- 21 The Role of Online Registries in Accelerating Alzheimer’s Disease Drug Development
- 22 Data Safety Monitoring Boards in Alzheimer’s Disease Trials
- 23 Globalization of Alzheimer’s Disease Clinical Trials
- 24 The Use and Development of Clinical Measures of Alzheimer’s Disease Trials
- 25 Tele-Trials, Remote Monitoring, and Trial Technology for Alzheimer’s Disease Clinical Trials
- 26 Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development
- 27 The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program
- 28 The Role of Regulatory Agencies in Alzheimer’s Disease Drug Development
- 29 Alzheimer’s Disease Clinical Trial Study Partners
- 30 From Trials to Practice: Are We Ready for a Disease-Modifying Treatment?
- 31 Best Practices for Clinical Trials during COVID-19
- Section 4 Imaging and Biomarker Development in Alzheimer’s Disease Drug Discovery
- Section 5 Academic Drug-Development Programs
- Section 6 Public–Private Partnerships in Alzheimer’s Disease Drug Development
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
20 - Alzheimer’s Disease Trial Recruitment and Diversifying Trial Populations
from Section 3 - Alzheimer’s Disease Clinical Trials
Published online by Cambridge University Press: 03 March 2022
Book contents
- Alzheimer’s Disease Drug Development
- Alzheimer’s Disease Drug Development
- Copyright page
- Dedication
- Contents
- Contributors
- Foreword
- Acknowledgments
- Section 1 Advancing Alzheimer’s Disease Therapies in a Collaborative Science Ecosystem
- Section 2 Non-clinical Assessment of Alzheimer’s Disease Candidate Drugs
- Section 3 Alzheimer’s Disease Clinical Trials
- 11 Phase 1 Trials in Alzheimer’s Disease Drug Development
- 12 The Importance of Phase 2 in Drug Development for Alzheimer’s Disease
- 13 Alzheimer’s Disease Drug Development in Pharmaceutical Companies
- 14 Trial Site Infrastructure and Management: Importance to Alzheimer’s Disease Drug Development
- 15 ATRI and ACTC: Academic Programs to Accelerate Alzheimer’s Disease Drug Development
- 16 The European Prevention of Alzheimer’s Disease Program: A Public–Private Partnership to Facilitate the Secondary Prevention of Alzheimer’s Disease Dementia
- 17 The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials
- 18 Clinical Trial Development in Frontotemporal Lobar Degeneration
- 19 Statistical Considerations in the Design and Analysis of Alzheimer’s Disease Clinical Trials
- 20 Alzheimer’s Disease Trial Recruitment and Diversifying Trial Populations
- 21 The Role of Online Registries in Accelerating Alzheimer’s Disease Drug Development
- 22 Data Safety Monitoring Boards in Alzheimer’s Disease Trials
- 23 Globalization of Alzheimer’s Disease Clinical Trials
- 24 The Use and Development of Clinical Measures of Alzheimer’s Disease Trials
- 25 Tele-Trials, Remote Monitoring, and Trial Technology for Alzheimer’s Disease Clinical Trials
- 26 Expanded Access and Compassionate Use in Alzheimer’s Disease Drug Development
- 27 The Role of the Contract Research Organization in Alzheimer’s Disease: The Vital Link in the Clinical Drug-Development Program
- 28 The Role of Regulatory Agencies in Alzheimer’s Disease Drug Development
- 29 Alzheimer’s Disease Clinical Trial Study Partners
- 30 From Trials to Practice: Are We Ready for a Disease-Modifying Treatment?
- 31 Best Practices for Clinical Trials during COVID-19
- Section 4 Imaging and Biomarker Development in Alzheimer’s Disease Drug Discovery
- Section 5 Academic Drug-Development Programs
- Section 6 Public–Private Partnerships in Alzheimer’s Disease Drug Development
- Section 7 Funding and Financing Alzheimer’s Disease Drug Development
- Index
- References
Summary
In conducting clinical trials, we evaluate the most promising findings from translational research, gain perspective about mechanisms of action, and strive to identify treatments that are both effective and safe for a wide range of Alzheimer’s disease (AD) patients. To assess the effectiveness of any clinical trial drug, we must first identify, screen, and follow representative participants through multiple trial phases, a years-long duration between discovery and efficacy. Clinical trials depend upon large, diverse, and well-characterized participant samples. Clinical trial populations must include representative variability across sociodemographic characteristics to capture unequal risk and potentially varied responses to treatment. Diverse participant samples are our best tool for generalizing effects to patient populations but are also one of our largest barriers to the timely and complete investigation of new treatments. Recruitment and retention receive some of the blame for the long, protracted timeline of clinical trials. Finding solutions for recruitment challenges will therefore improve the overall efficiency of study trials and the speed of drug discovery.
- Type
- Chapter
- Information
- Alzheimer's Disease Drug DevelopmentResearch and Development Ecosystem, pp. 249 - 256Publisher: Cambridge University PressPrint publication year: 2022
References
Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimers Dement 2020; 16: 391–460.Google Scholar
Babulal, GM, Quiroz, YT, Albensi, BC, et al. Perspectives on ethnic and racial disparities in Alzheimer’s disease and related dementias: update and areas of immediate need. Alzheimers Dement 2019; 15: 292–312.Google Scholar
Wong, R, Amano, T, Lin, S-Y, Zhou, Y, Morrow-Howell, N. Strategies for the recruitment and retention of racial/ethnic minorities in Alzheimer disease and dementia clinical research. Curr Alzheimer Res 2019; 16: 458–71.CrossRefGoogle ScholarPubMed
Ashford, MT, Eichenbaum, J, Williams, T, et al. Effects of sex, race, ethnicity, and education on online aging research participation. Alzheimers Dement (N Y) 2020; 6: 1–9.Google Scholar
McDonald, A, Knight, R, Cambell, M, et al. What influences recruitment to randomized controlled trials? A review of trials funded by two UK funding agencies. Trials 2006; 7: 1–8.Google Scholar
Dowling, NM, Olson, N, Mish, T, Kaprakattu, P, Gleason, C. A model for the design and implementation of a participant recruitment registry for clinical studies of older adults. Clin Trials 2012; 9: 204–14.Google Scholar
Hsu, D, Marshall, GA. Primary and secondary prevention trials in Alzheimer disease: looking back, moving forward. Curr Alzheimer Res 2016; 14: 426–40.Google Scholar
Aisen, PS, Sperling, RA, Cummings, J, et al. The Trial-Ready Cohort for Preclinical/Prodromal Alzheimer’s Disease (TRC-PAD) project: an overview. J Prev Alzheimers Dis 2020; 7: 208–12.Google Scholar
Rafii, MS, Aisen, PS. Alzheimer’s disease clinical trials: moving toward successful prevention. CNS Drugs 2019; 33: 99–106. https://doi.org/10.1007/s40263-018-0598-1.Google Scholar
Cummings, J, Lee, G, Ritter, A, Sabbagh, M, Zhong, K. Alzheimer’s disease drug-development pipeline: 2020. Alzheimers Dement (N Y) 2020; 6: e12050.Google Scholar
US Food and Drug Administration. Enhancing the diversity of clinical trial populations: eligibility criteria, enrollment practices, and trial designs guidance for industry. November 2020. www.fda.gov/regulatory-information/search-fda-guidance-documents/enhancing-diversity-clinical-trial-populations-eligibility-criteria-enrollment-practices-and-trial. Available at: www.fda.gov/media/127712/download November 17, 2020).Google Scholar
National Institute on Aging. Alzheimer’s disease and related dementias: clinical studies recruitment planning guide. Available at: www.nia.nih.gov/sites/default/files/2019-05/ADEAR-recruitment-guide-508.pdf (accessed June 17, 2020).Google Scholar
Heredia, NI, Strong, LL, Hatten, V. Community perceptions of biobanking participation: a qualitative study among Mexican-Americans in three Texas cities. Public Health Genom 2017; 20: 46–57.Google Scholar
Nuño, MM, Gillen, DL, Dosanjh, KK, et al. Attitudes toward clinical trials across the Alzheimer ’s disease spectrum. Alzheimers Res Ther 2017; 9: 81–90.CrossRefGoogle ScholarPubMed
Zhou, Y, Elashoff, D, Kremen, S, et al. African Americans are less likely to enroll in preclinical Alzheimer’s disease clinical trials. Alzheimers Dement (N Y) 2017; 3: 57–64.Google Scholar
Barnes, LL, Bennett, DA. Alzheimer’s disease in African Americans: risk factors and challenges for the future. Health Aff 2014; 33: 580–6.Google Scholar
Matthews, KA, Xu, W, Gaglioti, AH, et al. Racial and ethnic estimates of Alzheimer’s disease and related dementias in the United States (2015–2060) in adults aged ≥65 years. Alzheimers Dement 2019; 15: 17–24.CrossRefGoogle ScholarPubMed
Faison, WE, Schultz, SK, Aerssens, J, et al. Potential ethnic modifiers in the assessment and treatment of Alzheimer’s disease: challenges for the future. Int Psychogeriatr 2007; 19: 539–58.Google Scholar
Olin, JT, Dagerman, KS, Fox, LS, Bowers, B, Schneider, SL. Increasing ethnic minority participation in Alzheimer’s disease research. Alzheimer Dis Assoc Disord 2002; 16: S82–5.Google Scholar
Grill, JD, Kwon, J, Teylan, MA, et al. Retention of Alzheimer disease research participants. Alzheimer Dis Assoc Disord 2019; 33: 299–306.Google Scholar
Chêne, G, Beiser, A, Au, R, et al. Gender and incidence of dementia in the Framingham Heart Study from mid-adult life. Alzheimers Dement 2015; 11: 310–20.Google Scholar
Hebert, L, Weuve, J, Scherr, PA, Evans, D. Alzheimer’s disease in the United States (2010–2050) estimated using the 2010 Census. Neurology 2013; 80: 1778–83.Google Scholar
Plassman, BL, Langa, KM, Fisher, GG, et al. Prevalence of dementia in the United States: the aging, demographics, and memory study. Neuroepidemiology 2007; 29: 125–32.Google Scholar
Mehta, K, Yeo, G. Systematic review of dementia prevalence and incidence in US racial/ethnic populations. Alzheimers Dement 2017; 13: 72–83.Google Scholar
Weden, MM. Secular trends in dementia and cognitive impairment of U.S. rural and urban older adults. Am J Prev Med 2018; 54: 164–72.Google Scholar
Singh, GK, Siahpush, M. Widening rural–urban disparities in all-cause mortality and mortality from major causes of death in the USA, 1969–2009. J Urban Health 2014; 91: 272–92.CrossRefGoogle ScholarPubMed
Borak, J, Salipante-Zaidel, C, Slade, M, Fields, C. Mortality disparities in Appalachia: reassessment of major risk factors. J Occup Environ Med 2012; 54: 146–56.Google Scholar
Galvin, J, Fu, Q, Nguyen, J, Glasheen, C, Scharff, D. Psychosocial determinants of intention to screen for Alzheimer’s disease. Alzheimers Dement 2009; 4: 353–60.Google Scholar
Wiese, LK, Williams, CL, Tappen, RM. Analysis of barriers to cognitive screening in rural populations in the United States. Adv Nurs Sci 2014; 37: 327–39.Google Scholar
National Institute on Aging. Together we make the difference: national strategy for recruitment and participation in Alzheimer’s and related dementias clinical research. Available at: www.nia.nih.gov/research/recruitment-strategy (accessed October 22, 2020).Google Scholar
Marquez, DX, Glover, CM, Lamar, M, et al. Representation of older Latinxs in cohort studies at the Rush Alzheimer’s Disease Center. Neuroepidemiology 2020; 54: 404–18.Google Scholar
Williams, MM, Meisel, MM, Williams, J, Morris, JC. An interdisciplinary outreach model of African American recruitment for Alzheimer’s disease research. Gerontologist 2011; 51: 134–41.Google Scholar
Howell, JC, Parker, MW, Watts, KD, et al. Research lumbar punctures among African Americans and Caucasians: perception predicts experience. Front Aging Neurosci 2016; 8: 1–7.Google Scholar
Boise, L, Hinton, L, Rosen, HJ, Ruhl, M. Will my soul go to heaven if they take my brain? Beliefs and worries about brain donation among four ethnic groups. Gerontologist 2017; 57: 719–34.Google Scholar
Walter, S, Clanton, TB, Langford, OG, et al. Recruitment into the Alzheimer Prevention Trials (APT) Webstudy for a Trial-Ready Cohort for Preclinical and Prodromal Alzheimer’s Disease (TRC–PAD). J Prev Alzheimers Dis 2020; 7: 219–25.Google Scholar
Jimenez-Maggiora, GA, Bruschi, S, Raman, R, et al. TRC-PAD: accelerating recruitment of AD clinical trials through innovative information technology. J Prev Alzheimers Dis 2020; 7: 226–33.Google Scholar
Grill, JD, Monsell, SE. Choosing Alzheimer’s disease prevention clinical trial populations. Neurobiol Aging 2014; 35: 1–16.Google Scholar
Weuve, J, Sagiv, SK, Fox, MP. Quantitative bias analysis for collaborative science. Epidemiology 2018; 29: 627–30.Google Scholar
Burke, SL, Hu, T, Naseh, M, et al. Factors influencing attrition in 35 Alzheimer’s disease centers across the USA: a longitudinal examination of the National Alzheimer’s Coordinating Center’s Uniform Data Set. Aging Clin Exp Res 2019; 31: 1283–97.Google Scholar
Glymour, MM, Chěne, G, Tzourio, C, Brain, Dufouil C. MRI markers and dropout in a longitudinal study of cognitive aging: the three-city Dijon study. Neurology 2012; 79: 1340–8.Google Scholar
Crocker, JC, Ricci-Cabello, I, Parker, A, et al. Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis. BMJ 2018; 363: 1–17.Google Scholar