Clinical Research Studies

Discover, optimize, standardize, and validate clinical trial measures and biomarkers used in ongoing AD research. Aim 1. Longitudinal changes in cognition and associated biomarkers Determine and define those measures of cognition and function, including composite measures, and those biomarker measures, which capture longitudinal change with the highest statistical power to detect treatment effects in clinical trials. Longitudinal change of cerebral tau measured with 18F-AV-1451 PET (AV-1451) will be correlated/compared with other measures. Aim 2. Prediction of cognitive decline Determine which clinical, cognitive, and biomarker measures that best predict decline of cognition in CN, MCI, and AD participants. In addition, determine which biomarker changes correlate with cognitive decline, with focus on AV-1451 PET. Aim 3. Validation Validate biomarker measures obtained at Baseline and longitudinally by correlating results with “gold standard” clinical measurements and pathology. Aim 4. Clinical trial design Determine the optimum outcome measures with attention to cognitive decline and AV-1451 PET, predictors of cognitive decline, and inclusion/exclusion criteria for clinical trials of cognitively normal participants (for secondary preclinical AD trials), MCI patients (for prodromal AD trials) and participants with early dementia due to AD. Aim 5. Discovery To determine the effects of other known disease proteins found in AD brains and genes, as well as newly discovered genes, proteins, and analytes that provide useful information concerning the pathogenesis/diagnosis of AD. Protocol Clarifications: only those with the capacity to consent will be considered for retention in the ADNI study.