API Generation Program
The Alzheimer’s Prevention Initiative (API) Generation Program comprises two separate clinical trials, Generation Study 1 (GS1) and Generation Study 2 (GS2), that tested experimental Alzheimer’s treatments in individuals who carry one or two copies of the high-risk gene apolipoproten E ε4 (APOE4). APOE4 is estimated to be implicated in more than 50 percent of all cases of older-onset Alzheimer’s, the most common form of the disease. Though the trial was terminated before completing enrollment, the API Generation Program generated a large, shareable resource of biomaterial including blood based biomarkers, CSF and genomic material. These are available as: 1) cross-sectional aliquots from those who were successfully screened but not randomized to the trial, and 2) longitudinal aliquots from those who were randomized to the trial protocols (in varying stages of protocol completion). Follow the link here for more information.
Study Participants
Generation Study 1: More than 900 participants 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: More than 2,500 participants were screened to qualify as cognitively unimpaired (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.
Available Data
Screening and longitudinal data including demographics, neuropsychological testing, neuropsychological examination, cognitive testing, and neuroimaging data is available. A minimal dataset is available through the NCRAD catalog and the full dataset is available by request from University of Southern California Laboratory of Neuroimaging (USC LONI). Follow the link here for more information.
Available Biospecimens
Genomic DNA, Plasma, Serum, CSF