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Project Information

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GLOBAL ALZHEIMER'S PLATFORM TRIAL-READY COHORT FOR PRECLINICAL/PRODROMAL ALZHEIMER'S DISEASE

Agency:
NIA

HHS/NIH/National Institute on Aging (NIA)

Project Number:
5R01AG053798-02
Contact PI / Project Leader:
AISEN, PAUL S.
Awardee Organization:
UNIVERSITY OF SOUTHERN CALIFORNIA

Description

Abstract Text:
Global Alzheimer's Platform Trial-Ready Cohort for Preclinical/Prodromal Alzheimer's Disease (GAP TRC-PAD) Academic PIs: Paul Aisen, Reisa Sperling, Jeff Cummings SUMMARY Based on growing recognition that the long pre-dementia stages of Alzheimer's disease (AD) represent the optimal time for interventions aimed at modifying the neurobiology of the disease, most recent drug development programs enroll participants at the preclinical/asymptomatic and prodromal/mild cognitive impairment stages. However, the timeframe, complexity and expense of the recruitment process and site activation for these secondary prevention trials are extremely challenging, and indeed site start-up and trial enrollment, in general, represent the greatest bottleneck for drug development for AD. Thus, there is growing consensus in our field that we must fundamentally overhaul the current clinical trial recruitment and assessment process for these early intervention trials. The overarching goal of this proposal is to accelerate current and future secondary prevention trial enrollment through an innovative, highly efficient approach to identify, evaluate, and enroll appropriate preclinical and prodromal trial candidates, supported by a new site network with enhanced capacities for more efficient and effective conduct of AD clinical trials. It is our view that this can be accomplished only through a public-private partnership, the GAP Partnership, between this project and the GAP Foundation. Beginning in early 2014, the Global Alzheimer Platform (GAP) brought together academic, industry, advocacy and other Alzheimer's leaders to identify the necessary components to build large “trial-ready cohorts” (TRC) for preclinical/prodromal AD (PAD) trials (TRC-PAD) and to support a network (GAP-Net) of pre-qualified “trial-ready sites” with specific expertise in and uniform processes for the clinical and biomarker assessments required for prevention trials. The specific goal of the current project is to build a large TRC-PAD (n=2000; 1000 preclinical/1000 prodromal AD), to facilitate enrollment into ongoing PAD trials using the GAP-Net framework. This application describes a process of connecting existing “feeder” registries and studies to a GAP Registry to capture demographic, genetic and longitudinal clinical and cognitive information on older, non-demented individuals interested in trials. The Registry data generates risk scores for AD pathology (initially elevated amyloid in brain, but with methods adaptable to tau pathology and other biomarkers), that allows efficient selection of candidates for in-person biomarker (initially amyloid PET scans) and clinical assessment. The results of these assessments, in turn, allow an adaptive statistical algorithm to improve the selection process moving forward. Individuals with PET scans showing amyloid accumulation in brain (or alternative biomarker confirmation) are invited to join the GAP Cohort, with semi-annual in-person follow-up within the GAP-Net network of pre-qualified clinical sites, from which they can be invited to enroll in early stage trials. Overall, the process will dramatically shorten the timeline for preclinical/prodromal trials, and will address a series of scientific hypotheses to guide further development in the field.
Project Terms:
Address; Advocacy; Aging; Algorithms; Alzheimer disease prevention; Alzheimer's Disease; American; Amyloid; animal data; apolipoprotein E-4; base; Biological Markers; Brain; candidate selection; Clinical; Clinical assessments; clinical biomarkers; clinical research site; Clinical Trials; Cognitive; cognitive function; cognitive performance; cognitive testing; cohort; Collaborations; Communities; Consensus; Consent; cost; Country; Data; Data Collection; data registry; Dementia; demographics; Development; Disease; drug development; Early intervention trials; Eligibility Determination; Enrollment; European; experience; follow-up; Foundations; functional outcomes; Future; Genetic; Genetic Markers; Goals; health data; high risk; Home environment; Impaired cognition; improved; Individual; Industry; innovation; Insurance; interest; International; Internet; Intervention; Investments; Life; Medical; Medicine; Methods; mild cognitive impairment; Nerve Degeneration; Neurobiology; neuroimaging; non-demented; novel; Observational Study; Online Systems; Outcome Measure; Participant; Pathology; Performance; Persons; Pharmacy facility; Positron-Emission Tomography; pre-clinical; Prevention trial; Process; Process Assessment; Program Development; public-private partnership; recruit; Registries; Reporting; Resources; Risk; Secondary Prevention; Series; Site; Statistical Algorithm; System; tau Proteins; Technology; Testing; Time; TimeLine; Travel; United States National Institutes of Health; Work

Details

Contact PI / Project Leader Information:
Name:  AISEN, PAUL S.
Other PI Information:
CUMMINGS, JEFFREY L.; SPERLING, REISA A.
Awardee Organization:
Name:  UNIVERSITY OF SOUTHERN CALIFORNIA
City:  LOS ANGELES    
Country:  UNITED STATES
Congressional District:
State Code:  CA
District:  34
Other Information:
Fiscal Year: 2018
Award Notice Date: 08-May-2018
DUNS Number: 072933393
Project Start Date: 01-May-2017
Budget Start Date: 15-May-2018
CFDA Code: 866
Project End Date: 30-Apr-2022
Budget End Date: 30-Apr-2019
Agency: ?

Agency: The entity responsible for the administering of a research grant, project, or contract. This may represent a federal department, agency, or sub-agency (institute or center). Details on agencies in Federal RePORTER can be found in the FAQ page.

HHS/NIH/National Institute on Aging (NIA)
Project Funding Information for 2018:
Year Agency

Agency: The entity responsible for the administering of a research grant, project, or contract. This may represent a federal department, agency, or sub-agency (institute or center). Details on agencies in Federal RePORTER can be found in the FAQ page.

FY Total Cost
2018 NIA

HHS/NIH/National Institute on Aging (NIA)

$4,967,947

Results

i

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