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Activity Number: 499 - Recent Issues in the Design and Analysis of Clinical Trials in Neurodegenerative Disorders
Type: Invited
Date/Time: Thursday, August 11, 2022 : 8:30 AM to 10:20 AM
Sponsor: ENAR
Abstract #320456
Title: A Case Study Evaluating Alternative Analysis Methods in Longitudinal Alzheimer’s Disease Study, with Variable Subject Follow-Up
Author(s): Yevgen Tymofyeyev*
Companies: Janssen RD of J&J
Keywords: Alzheimer disease ; MMRM; polynomial regression; Bayesian model; adaptive

Drug development for patients in early stages of the Alzheimer disease presents many challenges including quantification of detrimental progression when using cognitive and functional scales. There seemed to be a consensus that a longer subject follow-up improves power to detect a treatment effect in terms of slowing the progression relative to placebo. A common-close type study results in a variable subject follow-up, as the study ends when the last randomized subject is observed for a given period. Alternatives analyses to the conventional method based on the mixed model for repeated measures (MMRM) were evaluated in this case study including the polynomial regression and Bayesian semi-parametric model proposed by Wang et al (2018) applied at interim and final analyses.

Authors who are presenting talks have a * after their name.

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