Alzheimer's prevention initiative apoe4 trial

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Project Title: Alzheimer's prevention initiative apoe4 trial
Project Number: 1UF1AG046150-01
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Tariot Pierre N, US
 
Project Description:
DESCRIPTION: The Alzheimer's Prevention Initiative (API) was established to rapidly evaluate investigational preclinical Alzheimer's disease (AD) treatments in cognitively unimpaired people who, based on their genetic background and age, are at the highest imminent risk for clinical progression, to help advance a new era in AD prevention research, and to find treatments that work as soon as possible. This application seeks five years of partial support for the initial stag of a 104-260 week multi-center randomized clinical trial of an investigational amyloid-¿ (A¿) modifying treatment in 650 cognitively unimpaired 60-75 year-old apolipoprotein E (APOE) ¿4 homozygotes (HMs) using the best established cognitive, brain imaging and cerebrospinal fluid (CSF) measurements of preclinical AD. The primary outcome is change in an empirically predefined composite cognitive test score. Other outcomes include changes in volumetric magnetic resonance imaging (MRI), fluorodeoxyglucose positron emission tomography (FDG PET) regional cerebral metabolic rate for glucose (rCMRgl), flutemetamol PET fibrillar A¿, and CSF A¿42, total tau (t-tau) and phospho-tau (p-tau) measurements. Adaptive elements include serial futility assessments, a 104-week interim analysis, and data and safety monitoring board (DSMB)-facilitated decisions about study continuation, study expansion, and the evaluation of other at-risk groups. Exploratory analyses will determine whether the treatment's 24-month treatment effects are related to the treatment's clinical effects and whether biomarker evidence of less extensive disease is associated with a greater therapeutic response. This study complements API's funded trial in autosomal dominant AD (ADAD) mutation carriers. It capitalizes on our longstanding efforts to characterize the preclinical biomarker and cognitive changes in APOE ¿4 HM, heterozygotes (HTs) and noncarriers (NCs), several of the API's established policies, procedures, and collaborative relationships, its data and sample-sharing paradigm and growing Alzheimer's Prevention Registry, and at least $50 million in additional industry and philanthropic funding. Our potentially license-enabling APOE ¿4 and ADAD mutation carrier trials have been vetted by leading academic, industry, NIA, regulatory agency, and community stakeholders. The project's aims: to evaluate an investigational A¿-modifying treatment in unimpaired HMs, to provide a better test of the amyloid hypothesis, to determine whether to evaluate the treatment in others at risk for late-onset AD, to help clarify the extent t which a treatment's biomarker effects may predict a clinical response and qualify as reasonably likely surrogate endpoints in future preclinical trials, to provide information about the impact o APOE genetic test disclosure in this new era of AD prevention research, to provide a public resource of data and samples after the trial is over, and to complement and support other research programs related to the evaluation of preclinical AD treatments. The project is intended to help find effective preclinical treatments for late-onset AD as soon as possible.
 
Project Terms:
age alzheimer disease prevention alzheimer's disease alzheimer's disease risk amyloid apolipoprotein e base biological biological markers brain imaging brain volume cerebrospinal fluid cerebrum clinical clinical effect clinical risk clinical trials data monitoring committees clinical trials design cognitive cognitive change communities complement complement component c6 data development disclosure disease-causing mutation effective therapy elderly elements enrollment european evaluation fight against fluorodeoxyglucose positron emission tomography funding futility future genes genetic genetic risk factor genetic screening method genotype glucose goals health heterozygote homozygote individual industry investigational therapies late onset alzheimer disease lead licensing magnetic resonance imaging measurement measures medicine meetings metabolic methods motivation mutation carrier outcome participant persons pharmacologic substance philanthropic fund placebo control placebos policies positron-emission tomography pre-clinical preclinical evaluation preclinical study prevent prevention research prevention therapy primary outcome procedures programs qualifying randomized randomized clinical trials registries request for proposals research research infrastructure resources response risk safety sampling series specific qualifier value staging surrogate endpoint symptoms tau proteins testing theories therapeutic therapy clinical trials time treatment effect trend united states national institutes of health uptake widespread disease work aging brain disorders clinical research clinical trials dementia diagnostic radiology genetic testing genetics neurodegenerative neurosciences prevention
Project Title: Alzheimer's prevention initiative apoe4 trial
Project Number: 1UF1AG046150-01
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Tariot Pierre N, US
 
Project Categories:
Natural Sciences
 
Other Information:
Fiscal Year: 2013
Project Start Date: 20 September 2013
Project End Date: 31 August 2018
Project program: Multi-Year Funded Research Project Cooperative Agreement
 
Project Funding Information:
Funding Mechanism: Non-SBIR/STTR RPGs
Year Funding Organization Total Funding, $
2013 NIH - National Institute On Aging $33,260,235
Project Title: Alzheimer's prevention initiative apoe4 trial
Project Number: 1UF1AG046150-01
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Tariot Pierre N, US
 
Title FY Funding
There are no results for this project in database.
Project Title: Alzheimer's prevention initiative apoe4 trial
Project Number: 1UF1AG046150-01
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Tariot Pierre N, US
 
Project Title Organization FY Funding
Alzheimer'S Prevention Initiative Apoe4 TrialBanner Alzheimer'S Institute2013$33,260,235
Project Title: Alzheimer's prevention initiative apoe4 trial
Project Number: 1UF1AG046150-01
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, US
Tariot Pierre N, US
 
Project number Project title Principal investigator
There are no any related projects.
Project Title: Alzheimer's prevention initiative apoe4 trial
Project Number: 1UF1AG046150-01
Project web address: Follow on NIH
Organization: Banner Alzheimer'S Institute, United States, Arizona, PHOENIX
Principal Investigators (PI): Reiman Eric M, 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
What are we willing to accept for preventing Alzheimer's disease? - Investigators' reply. Lancet Neurol 2016 england
CAP--advancing the evaluation of preclinical Alzheimer disease treatments. Nat Rev Neurol 2016 england