Keywords: Alzheimer's disease, biomarker comparison, ADNI
Alzheimer’s disease (AD) is widespread in the elderly population and clinical trials are ongoing, focused on elderly individuals with mild cognitive impairment (MCI), AD dementia, or pre-clinical AD, to identify drugs that will help with this destructive disease. To date, all clinical trials of disease modifying drugs have failed. Well-chosen biomarkers have the potential to increase the efficiency of clinical trials and drug discovery. The Alzheimer’s Disease Neuroimaging Initiative (ADNI) began in 2003 with a goal of identifying sensitive and specific markers of very early AD progression. Elderly individuals who were cognitively normal, had MCI, or had mild AD were recruited into the study and followed over time. Imaging (including magnetic resonance imaging and positron emission tomography), neuropsychological testing, and cerebrospinal fluid samples were obtained at least annually. Ways in which ADNI data have been used to identify promising markers, support biomarker qualification applications to the Food and Drug Administration and European Medicines Agency, and modify clinical trial design will be presented.