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17 - The Global Alzheimer’s Platform Foundation®: Delivering New Medicines Faster by Accelerating Clinical Trials

from Section 3 - Alzheimer’s Disease Clinical Trials

Published online by Cambridge University Press:  03 March 2022

By
Jason Bork ,
Cyndy Cordell ,
John Dwyer ,
Gabe Goldfeder ,
Debra R. Lappin ,
Richard Mohs ,
Julie Neild ,
Rona Schillinger ,
Jill Smith  and
Katy Smith
...Show all authors
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

The Global Alzheimer’s Platform Foundation® (GAP) is a patient-centric, non-profit organization founded in 2015. GAP is dedicated to speeding the delivery of innovative therapies to persons with Alzheimer’s disease (AD) or Parkinson’s disease (PD) by reducing the duration and cost while improving the effectiveness of AD and PD clinical trials. GAP’s growing network of high-performing AD and PD sites (GAP-Net) allows sponsors to complete clinical trials on a single, optimized trial site platform. GAP-Net sites activate 30% faster than non-GAP sites by leveraging trial services including a central institutional review board. GAP-Net sites experience up to a 24% faster screening rate, higher randomization rates, and fewer low/no randomizations per site compared with sites without the support of GAP Participant Services (GPS). GAP also sponsors the Bio-Hermes trial , designed to evaluate digital and blood-based biomarkers that are projected to accelerate enrollment and lower screen fail costs in clinical trials. Finally, GAP is extending its network globally as part of its mission to accelerate and improve the effectiveness of AD and PD clinical trials.

Keywords

Clinical trial site networkAccelerated study start upCentral Institutional Review Board (IRB)Customized recruitment approachesBlood-based and digital biomarkersRater certificationMinority recruitment
Type
Chapter
Information
Alzheimer's Disease Drug Development
Research and Development Ecosystem
 , pp. 207 - 215
Publisher: Cambridge University Press
Print publication year: 2022

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References

Vradenburg, G. Catalyzing the Landmark G8 Commitment. HuffPost 2013; December 23. Available at: www.huffpost.com/entry/catalyzing-the-landmark-g8-commitment_b_4489405 (accessed November 24, 2020).Google Scholar
Mathias, A, Lamberti, MJ, Getz, K. ‘START’ (Start-up Time And Readiness Tracking) study: Working Group final report. Tufts Center for the Study of Drug Development (CSDD). Released June 15, 2012.Google Scholar
Amjad, H, Roth, DL, Sheehan, OC, et al. Underdiagnosis of dementia: an observational study of patterns in diagnosis and awareness in US older adults. J Gen Intern Med 2018; 33: 1131–8.Google Scholar
Carr, SA, Davis, R, Spencer, D, et al. Comparison of recruitment efforts targeted at primary care physicians versus the community at large for participation in Alzheimer disease clinical trials. Alzheimer Dis Assoc Disord 2010; 24: 165–70.Google Scholar
Research!America. Public perception of clinical trials. July 2017. Available at: www.researchamerica.org/sites/default/files/July2017ClinicalResearchSurveyPressReleaseDeck_0.pdf (accessed November 24, 2020).Google Scholar
Murphy-Barron, C, Pyenson, B, Ferro, C, Emery, M. Comparing the demographics of enrollees in Medicare Advantage and fee-for-service medicare. Milliman report. October 2020. Available at: www.bettermedicarealliance.org/publication/comparing-the-demographics-of-enrollees-in-medicare-advantage-and-fee-for-service-medicare/ (accessed November 24, 2020).Google Scholar
Alzheimer’s Association. 2020 Alzheimer’s disease facts and figures. Alzheimers Dement 2020; 16: 391–460.Google Scholar
Shin, J, Doraiswamy, PM. Underrepresentation of African-Americans in Alzheimer’s trials: a call for affirmative action. Front Aging Neurosci 2016; 8: 123.CrossRefGoogle Scholar
National Institutes of Health. NIH RCDC inclusion statistics report. Available at: https://report.nih.gov/RISR/#/ (accessed November 24, 2020).Google Scholar
United States Census Bureau. Quick facts United States. 2020. Available at: www.census.gov/quickfacts/fact/table/US/PST045219 (accessed November 24, 2020).Google Scholar
US Food and Drug Administration. Qualification process for drug development tools guidance for industry and FDA staff draft guidance. November 2020. Available at: www.fda.gov/media/133511/download (accessed November 24, 2020).Google Scholar
Clark, CM, Pontecorvo, MJ, Beach, TB, et al. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-β plaques: a prospective cohort study. Lancet Neurol 2012; 11: 669–78.CrossRefGoogle ScholarPubMed
Schwarz, AJ, Yu, P, Miller, BB, et al. Regional profiles of the candidate tau PET ligand 18F-AV-1451 recapitulate key features of Braak histopathological stages. Brain 2016; 139: 1539–50.Google Scholar
Jack, CR, Bennett, DA, Blennow, K, et al. A/T/N: an unbiased descriptive classification scheme for Alzheimer disease biomarkers. Neurology 2016; 87: 539–47.Google Scholar
Nakamura, A, Kaneko, N, Villemagne, VL, et al. High performance plasma amyloid-β biomarkers for Alzheimer’s disease. Nature 2018; 554: 249–54.CrossRefGoogle ScholarPubMed
Palmqvist, S, Janelidze, S, Quiroz, YT, et al. Discriminative accuracy of plasma phosphor-tau217 for Alzheimer disease vs other neurodegenerative disorders. JAMA 2020; 324: 772–81.Google Scholar
Morgan, AR, Touchard, S, Leckey, C, et al. Inflammatory biomarkers in Alzheimer’s disease plasma. Alzheimers Dement 2019; 15: 776–87.CrossRefGoogle ScholarPubMed
Welsh, KA, Butters, N, Mohs, RC, et al. The Consortium to Establish a Registry for Alzheimer’s Disease (CERAD). Part V. A normative study of the neuropsychological battery. Neurology 1994; 44: 609–14.Google Scholar
Kourtis, LC, Regele, OB, Wright, JM, Jones, GB. Digital biomarkers for Alzheimer’s disease: the mobile wearable devices opportunity. NPJ Digit Med 2019; 2: 1–9.CrossRefGoogle ScholarPubMed
McKhann, GM, Knopman, DS, Chertkow, H, et al. The diagnosis of dementia due to 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: 263–9.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: 735–45.Google Scholar
Ritchie, CW, Molinuevo, JL, Truyen, L, et al. Development of interventions for the secondary prevention of Alzheimer’s dementia: the European Prevention of Alzheimer’s Dementia (EPAD) project. Lancet Psychiatry 2016; 3: 179–86.Google Scholar

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