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