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21 - The Role of Online Registries in Accelerating Alzheimer’s Disease Drug Development

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Sarah Walter ,
Jessica Langbaum  and
Rachel Nosheny
Edited by
Jeffrey Cummings ,
Jefferson Kinney  and
Howard Fillit
Jeffrey Cummings
Affiliation:
University of Nevada, Las Vegas
Jefferson Kinney
Affiliation:
University of Nevada, Las Vegas
Howard Fillit
Affiliation:
Alzheimer’s Drug Discovery Foundation
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Summary

Registries play an important role of identifying large groups of individuals who may be eligible for clinical trials. Major advantages include scalability, ability to reach many individuals with few resources, and to connect with individuals who may not otherwise engage in research. Major challenges include generalizability, data integrity, data validity, and study drop-out. This chapter reviews the four largest online registries in the USA: the Brain Health Registry, the Alzheimer’s Prevention Registry and GeneMatch, Cleveland Clinic’s HealthyBrains, and Alzheimer’s Association TrialMatch. Participant engagement strategies and current demographics are summarized. We also discuss a newly established program to create Trial-ready Cohort for Preclinical and Prodromal AD (TRC-PAD) with the aim to accelerate clinical trial enrollment. It is important to build a large cohort, to identify enough participants eligible and interested in clinical trials. Compatibility with smartphones, and further study of engagement and retention strategies with a focus on under-represented groups are critical to achieve our ultimate goal of trial participants representing the full US population.

Keywords

Registryonline registryremote studyresearch participantclinical trial recruitmenttrial-ready cohortwebstudypreclinical Alzheimer’s disease
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 257 - 265
Publisher: Cambridge University Press
Print publication year: 2022

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References

Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimers Dement 2020; 16: 391–460.CrossRefGoogle Scholar
Fargo, KN, Carrillo, MC, Weiner, MW, Potter, WZ, Khachaturian, Z. The crisis in recruitment for clinical trials in Alzheimer’s and dementia: an action plan for solutions. Alzheimers Dement 2016; 12: 1113–15.CrossRefGoogle ScholarPubMed
Grill, JD, Karlawish, J. Addressing the challenges to successful recruitment and retention in Alzheimer’s disease clinical trials. Alzheimers Res Ther 2010; 2: 34.CrossRefGoogle ScholarPubMed
Tang, M-X, Cross, P, Andrews, H, et al. Incidence of AD in African-Americans, Caribbean Hispanics, and Caucasians in northern Manhattan. Neurology 2001; 56: 49–56.CrossRefGoogle ScholarPubMed
Sperling, RA, Aisen, PS, Beckett, LA, et al. Toward defining the preclinical stages of Alzheimer’s disease: recommendations from the National Institute on Aging–Alzheimer’s Association workgroups on diagnostic guidelines for Alzheimer’s disease. Alzheimers Dement 2011; 7: 280–92.Google Scholar
Norton, S, Matthews, FE, Barnes, DE, Yaffe, K, Brayne, C. Potential for primary prevention of Alzheimer’s disease: an analysis of population-based data. Lancet Neurol 2014; 13: 788–94.Google Scholar
Ovod, V, Ramsey, KN, Mawuenyega, KG, et al. Amyloid beta concentrations and stable isotope labeling kinetics of human plasma specific to central nervous system amyloidosis. Alzheimers Dement 2017; 13: 841–9.Google Scholar
Mattsson-Carlgren, N, Janelidze, S, Palmqvist, S, et al. Longitudinal plasma p-tau217 is increased in early stages of Alzheimer’s disease. Brain 2020; 143: 3234–41.Google Scholar
Aisen, P, Touchon, J, Andrieu, S, et al. Registries and cohorts to accelerate early phase Alzheimer’s trials. A report from the E.U./U.S. Clinical Trials in Alzheimer’s Disease Task Force. J Prev Alzheimers Dis 2016; 3: 68–4.Google ScholarPubMed
Kluding, PM, Denton, J, Jamison, TR, et al. Frontiers: integration of a research participant registry with medical clinic registration and electronic health records. Clin Transl Sci 2015; 8: 405–11.CrossRefGoogle ScholarPubMed
Grill, JD. Recruiting to preclinical Alzheimer’s disease clinical trials through registries. Alzheimers Dement (N Y) 2017; 3: 205–12.Google Scholar
Jeon, YH, Fargo, K, Smith, A, et al. Comparison of digital platforms for participant recruitment in dementia research: lessons and future directions from a global collaborative: epidemiology/innovative methods in epidemiology (i.e., assessment methods, design, recruitment strategies, statistical methods, etc.). Alzheimers Dement 2020; 16: e046401.Google Scholar
Weiner, MW, Nosheny, R, Camacho, M, et al. The Brain Health Registry: an internet-based platform for recruitment, assessment, and longitudinal monitoring of participants for neuroscience studies. Alzheimers Dement 2018; 14: 1063–76.CrossRefGoogle Scholar
Mackin, RS, Insel, PS, Truran, D, et al. Unsupervised online neuropsychological test performance for individuals with mild cognitive impairment and dementia: results from the Brain Health Registry. Alzheimers Dement (Amst) 2018 10: 573–82.Google Scholar
Nosheny, RL, Camacho, MR, Insel, PS, et al. Online study partner-reported cognitive decline in the Brain Health Registry. Alzheimers Dement 2018; 4: 565–74.Google Scholar
Nosheny, RL, Camacho, MR, Jin, C, et al. Validation of online functional measures in cognitively impaired older adults. Alzheimers Dement 2020; 16: 1426–37.CrossRefGoogle ScholarPubMed
Ashford, MT, Neuhaus, J, Jin, C, et al. Predicting amyloid status using self-report information from an online research and recruitment registry: the Brain Health Registry. Alzheimers Dement (Amst) 2020; 12: e12102.Google 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: e12028.Google Scholar
Fockler, JK, Ashford, MT, Flenniken, D, et al. Brain Health Registry GenePool study: a novel approach to online genetics research. Alzheimers Dement (N Y) 2021; 7: e12118.Google Scholar
Langbaum, JB, High, N, Nichols, J, et al. The Alzheimer’s Prevention Registry: a large internet-based participant recruitment registry to accelerate referrals to Alzheimer’s-focused studies. J Prev Alzheimers Dis 2020; 7: 242–50.Google Scholar
Reiman, EM, Langbaum, JB, Tariot, PN. Alzheimer’s Prevention Initiative: a proposal to evaluate presymptomatic treatments as quickly as possible. Biomark Med 2010; 4: 3–14.Google Scholar
Langbaum, JB, Karlawish, J, Roberts, JS, et al. GeneMatch: a novel recruitment registry using at-home APoE genotyping to enhance referrals to Alzheimer’s prevention studies. Alzheimers Dement 2019; 15: 515–24.Google Scholar
Zhong, K, Cummings, J. Healthybrains.org: from registry to randomization. J Prev Alzheimers Dis 2016; 3: 123–6.Google Scholar
Amariglio, RE, Donohue, MC, Marshall, GA, et al. Tracking early decline in cognitive function in older individuals at risk for Alzheimer disease dementia. JAMA Neurol 2015; 72: 446.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
Sperling, RA, Donohue, MC, Raman, R, et al. Association of factors with elevated amyloid burden in clinically normal older individuals. JAMA Neurol 2020; 77: 735.CrossRefGoogle ScholarPubMed
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 ScholarPubMed
Langford, O, Raman, R, Sperling, RA, et al. Predicting amyloid burden to accelerate recruitment of secondary prevention clinical trials. J Prev Alzheimers Dis 2020; 7: 213–18.Google ScholarPubMed
Walter, S, Langford, OG, Clanton, TB, et al. The Trial-Ready Cohort for Preclinical and Prodromal Alzheimer’s Disease (TRC-PAD): experience from the first 3 years. J Prev Alzheimers Dis 2020; 4: 234–41.Google Scholar
Perrin, A, Turner, E. Smartphones help blacks, Hispanics bridge some – but not all – digital gaps with whites. Available at: www.pewresearch.org/fact-tank/2019/08/20/smartphones-help-blacks-hispanics-bridge-some-but-not-all-digital-gaps-with-whites/ (accessed April 2020).Google Scholar

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