Available Samples
Biospecimens Available on Request from API Generation Program: Generation Study 1 (GS1) and Generation Study 2 (GS2)
Available Biospecimens
Genomic DNA, Plasma, Serum, and CSF are all available on request from Indiana University National Centralized Repository for Alzheimer’s Disease and Related Dementias (NCRAD).
Study Design
The API Generation Program comprises two separate clinical trials, GS1 and GS2, that tested experimental Alzheimer’s treatments in individuals who carry one or two copies of the high-risk gene, apolipoprotein E ε4 (APOE4). APOE4 is estimated to be implicated in more than 50% 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).
Study Subjects
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 are available. A minimal dataset is available through the NCRAD catalog. For full dataset access, see our Available Data page.