Estimating attrition in mild-to-moderate Alzheimer’s disease and mild cognitive impairment clinical trials

Autor: Marina Ritchie, Daniel L. Gillen, Joshua D. Grill
Jazyk: angličtina
Rok vydání: 2023
Předmět:
Zdroj: Alzheimer’s Research & Therapy, Vol 15, Iss 1, Pp 1-5 (2023)
Druh dokumentu: article
ISSN: 1758-9193
DOI: 10.1186/s13195-023-01352-0
Popis: Abstract Background Participant retention is a key factor that affects clinical trial integrity. Trial protocols estimate attrition as a function of sample size calculations. Alzheimer’s disease (AD) is an area of active treatment development. We aimed to quantify the association between trial duration and completion rates and provide guidance for estimating attrition in AD trial protocols. Methods Using the Alzforum and ClinicalTrials.gov databases, we analyzed retention data from 125 mild-to-moderate AD and 12 mild cognitive impairment (MCI) clinical trials. We compared the rates of completion between trial arms (active vs. control) and ran regression models to test the hypothesis that trials with longer study duration have lower trial completion using all available data and restricting to placebo data. Our primary outcome was the odds of trial completion for a 6-month increase in trial duration. From the regression model, we estimated the proportion of participants completing 6-, 12-, and 18-month trials. Results We found that 21 (17%) mild-to-moderate AD trials and 1 (8%) MCI trial demonstrated greater dropout in treatment compared to placebo arms. For every 6-month increase in trial duration, there was a 27% decrease in the odds of trial completion (OR = 0.73; 95% CI 0.66, 0.81; p
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