Alzheimer's prevention initiative

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Project Title: Alzheimer's prevention initiative
Project Number: 1RF1AG041705-01A1
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Lopera Francisco, US
Tariot Pierre N, US
 
Project Description:
It takes too many healthy volunteers and too many years to evaluate promising presymptomatic Alzheimer's disease (AD) treatments, interventions intended to reduce the risk of AD symptoms or prevent them completely, using clinical endpoints. While AD biomarkers are needed to rapidly evaluate the range of promising presymptomatic AD treatments, regulatory agencies are unlikely to qualify them for use as surrogate endpoints under their accelerated approval provisions until randomized clinical trials (RCTs) clarify the extent to which the biomarkers respond to AD-modifying treatments and are reasonably likely to predict a clinical benefit. The Alzheimer's Prevention Initiative (API) is intended to help accelerate the evaluation of promising presymptomatic AD treatments and find ones that work as soon as possible. This application seeks five years of partial support for the first stage of a multi-center, randomized, placebo-controlled, adaptive-design trial. This initial 104 week trial is of an investigational amyloid-modifying treatment for 200 cognitively normal, autosomal- dominant early-onset AD (EOAD) mutation carriers (and 100 matched placebo-treated non-carriers) who are within 15 years of their estimated age at clinical onset. An adaptive element uses serial futility analyses and an interim analysis at 104 weeks for a study continuation decision. Outcomes include the best established brain imaging and cerebrospinal fluid (CSF) biomarkers of AD and a sensitive composite cognitive endpoint. Most participants will be presenilin 1 (PS1) E280A mutation carriers and placebo-treated non-carriers from the world's largest, known EOAD kindred in Antioquia, Colombia. US participants are included to share opportunities and risks with the Colombian volunteers. This is an extremely inclusive project, having been vetted by leading academic and community stakeholder advisors, and representatives from the NIA, FDA, European Medicines Agency, and pharmaceutical research companies. One third of the funding is requested from the NIA, contingent upon pharmaceutical industry and Banner Alzheimer's Foundation commitments for the remaining funds, ensuring that the data and biological samples are available to the public upon study completion to further develop the biomarkers needed to rapidly evaluate presymptomatic treatments in other populations and trials. To help launch a new era in AD prevention research, the project aims to (1) conduct the first stage of an RCT of an investigational amyloid-modifying treatment in presymptomatic EOAD mutation carriers, (2) determine the extent to which the treatment's biomarker effects at week 104 predict subsequent clinical effect, (3) determine the extent to which the biomarkers are prognostic or predictive of AD, (4) compare baseline and longitudinal measurements in mutation carrier and non-carrier placebo treatment groups, (5) provide almost 1,000 mutation carriers and a public resource of data and biological samples as soon as possible after the trial is completed, and (6) complement and support other important programs (e.g., in the DIAN, ADCS, ADNI and a US-based API Registry and an RCT in APOE ¿4 homozygotes and heterozygotes). PUBLIC HEALTH RELEVANCE: It currently takes too many people, too much money, and too many years to evaluate Alzheimer's disease (AD) prevention therapies. The Alzheimer's Prevention Initiative (API) is intended to start evaluating promising experimental treatments in people who, based on their genetic background and age, are at the highest imminent risk of development the memory and thinking problems associated with AD-including members from the world's largest extended family of early-onset AD mutation carriers in Medellin, Colombia. The API is intended to help establish the biological measurements and accelerated FDA approval pathway needed to rapidly evaluate promising prevention therapies and find ones that work as quickly as possible.
 
Project Terms:
age alzheimer disease prevention alzheimer's disease alzheimer's disease risk amyloid apolipoprotein e apolipoprotein e-4 base biological biological markers brain brain imaging brain volume cerebrospinal fluid cerebrum clinical clinical effect clinical trials data monitoring committees clinical trials design cognitive colombia communities complement component c6 cooperative study data databases development drug industry effective therapy elements ensure european evaluation extended family fluorodeoxyglucose positron emission tomography foundations funding futility genetic glucose goals healthy volunteer heterozygote homozygote impaired cognition inherited interest intervention kindred magnetic resonance imaging measurement measures medicine meetings member memory metabolic modeling mutation carrier neuroimaging outcome participant pathway interactions pharmacologic substance placebo control placebos population positron-emission tomography preparation presenile alzheimer dementia presenilin-1 prevent prevention research prevention therapy prognostic programs qualifying randomized randomized clinical trials registries research research infrastructure research project grants resources response risk sampling series specific qualifier value staging surrogate endpoint symptoms tau proteins thinking treatment effect volunteer week trial work aging brain disorders clinical research clinical trials diagnostic radiology genetics neurodegenerative neurosciences patient safety prevention
Project Title: Alzheimer's prevention initiative
Project Number: 1RF1AG041705-01A1
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Lopera Francisco, US
Tariot Pierre N, US
 
Project Categories:
Natural Sciences
 
Other Information:
Fiscal Year: 2012
Project Start Date: 18 May 2012
Project End Date: 30 April 2017
Project program: Multi-Year Funded Research Project Grant
 
Project Funding Information:
Funding Mechanism: Non-SBIR/STTR RPGs
Year Funding Organization Total Funding, $
2012 NIH - National Institute On Aging $15,252,950
Project Title: Alzheimer's prevention initiative
Project Number: 1RF1AG041705-01A1
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Lopera Francisco, US
Tariot Pierre N, US
 
Title FY Funding
There are no results for this project in database.
Project Title: Alzheimer's prevention initiative
Project Number: 1RF1AG041705-01A1
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Lopera Francisco, US
Tariot Pierre N, US
 
Project Title Organization FY Funding
Alzheimer'S Prevention InitiativeBanner Alzheimer'S Institute2012$15,252,950
Project Title: Alzheimer's prevention initiative
Project Number: 1RF1AG041705-01A1
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Lopera Francisco, US
Tariot Pierre N, US
 
Project number Project title Principal investigator
There are no any related projects.
Project Title: Alzheimer's prevention initiative
Project Number: 1RF1AG041705-01A1
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Lopera Francisco, US
Tariot Pierre N, US
 
Title Journal Year Country Rel
Collaboration for Alzheimer's Prevention: Principles to guide data and sample sharing in preclinical Alzheimer's disease trials. Alzheimers Dement 2016 united states