Determining clinically meaningful decline in preclinical Alzheimer disease.

ABSTRACT:

Objective

To determine the time required for a preclinical Alzheimer disease population to decline in a meaningful way, use estimates of decline to update previous clinical trial design assumptions, and identify factors that modify β-amyloid (Aβ)-related decline.

Methods

In 1,120 cognitively unimpaired individuals from 3 international cohorts, we estimated the relationship between Aβ status and longitudinal changes across multiple cognitive domains and assessed interactions between Aβ and baseline factors. Power analyses were performed to explore sample size as a function of treatment effect.

Results

Cognitively unimpaired Aβ+ participants approach mild cognitive impairment (MCI) levels of performance 6 years after baseline, on average. Achieving 80% power in a simula

SUBMITTER: Insel PS 

PROVIDER: S-EPMC6669933 | biostudies-literature | 2019 Jul

REPOSITORIES: biostudies-literature