Investigator:David Cash
Title:Sample size estimates for biomarkers in prevention trials
Date of Request:04/17/2024
Aim 1:Assess the rate and variance of serial imaging measures in the Dominantly Inherited Alzheimer Network (DIAN) study
Aim 2:Compare sample size estimates from imaging outcomes with biofluid and cognitive measures
Aim 3:Assess the different power and design requirements for studies using different potential trial inclusion criteria (including but not limited to estimated years to onset, amyloid and tau positivity, cogntiive status) and suitable target treatment effects (reduced rate of atrophy/cognitive decline or reduction of absolute levels of AD-related pathology by end of study)
Aim 4Assess and compare the requirements for classical parallel arm trial design with more novel approaches (run-in designs, common close, staggered starts)