1. Effects of informant replacement in Alzheimer's disease clinical trials
- Author
-
Nishida, Mikaela K, Nuño, Michelle M, Grill, Joshua D, and Gillen, Daniel L
- Subjects
Biomedical and Clinical Sciences ,Biological Psychology ,Clinical Sciences ,Neurosciences ,Psychology ,Dementia ,Brain Disorders ,Alzheimer's Disease ,Aging ,Alzheimer's Disease including Alzheimer's Disease Related Dementias (AD/ADRD) ,Acquired Cognitive Impairment ,Neurodegenerative ,activities of daily living ,Alzheimer's Disease Cooperative Study ,informant ,informant replacement ,study partner ,Clinical sciences ,Biological psychology - Abstract
IntroductionAlzheimer's disease (AD) trials require enrollment with an informant.MethodsWe assessed relationships between informant replacement and Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scores across four AD trials. Using generalized estimating equations, we examined associations between replacement and change in ADCS-ADL between successive visits. We used analysis of covariance to estimate the association between replacement and 18-month change from baseline, and an F-test to compare the variance of this change.ResultsAmong 1336 participants, 63 (≈5%) experienced replacement. Between-visit mean change in ADCS-ADL was 2.44 points lower comparing replacement to stable informants (95% confidence interval [CI]: -3.91, -0.98). The difference in between-visit mean absolute change was 2.38 points (95% CI: 1.24, 3.52). Replacement was not significantly associated with an 18-month change from baseline. The ratio of variances (replacement/stable) was 1.80 (95% CI: 1.19, 2.99).DiscussionInformant replacement is associated with bias and increased variability between visits and increased variance for overall ADCS-ADL.
- Published
- 2023