The Alzheimer’s Prevention Initiative Generation Study, a Generation Program (API Generation) that comprises two separate clinical trials, Generation Study 1 (Gen1) and Generation Study 2 (Gen2). These trials tested experimental Alzheimer’s treatments in individuals who carry one or two copies of the high-risk gene apolipoprotein E ε4 (APOE4). Though the trial was closed before completing enrollment, API Generation generated a large, shareable resource of data including cognitive testing, biomarker analyses, and comprehensive trial data.
Generation Study 1 includes more than 900 participants that were screened to qualify as cognitively unimpaired (MMSE >=24 and through memory test evaluations) males and females (post-menopausal) aged 60-75 with homozygous APOE4 genotype. More than 400 of these participants were randomized to the trial.
Generation Study 2 includes more than 2,500 participants that were screened to qualify as cognitively unimpaired (MMSE >=24 and through memory test evaluations) males and females (post-menopausal) aged 60-75 with at least one APOE4 gene. If heterozygous for APOE4, then must have elevated brain amyloid as measured by CSF Abeta or amyloid PET imaging. More than 1,000 of these participants were randomized to the trial.
Cross sectional data are available from those participants that were successfully screened but not randomized to the trial. Longitudinal data are available from those participants who were randomized to the trial protocols (randomized participant data reports varying stages of protocol completion).
Information regarding additional available study resources including PET and MRI neuroimaging and residual biomaterial from Generation Studies 1 and 2 can be requested through: APIData@bannerhealth.com.
Manuscripts citing this dataset
- Rosiglitazone does not improve cognition or global function when used as adjunctive therapy to AChE inhibitors in mild-to-moderate Alzheimer's disease: two phase 3 studies. 2011. DOI: 2174/156720511796391935
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