ArticleAlzheimer's & dementia (New York, N. Y.)
Impacts of informant replacement in two industry-sponsored Alzheimer's disease clinical trials.
Article in Alzheimer's & dementia (New York, N. Y.). The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
1 citing paper in PubMed.
- Impact of study partner replacement in a mild cognitive impairment clinical trial.Alzheimer's & dementia (New York, N. Y.)Article
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Authors and funding
4 authors.
Funding
Abstract
introductionIn Alzheimer's disease (AD) clinical trials, participants must enroll with a study partner informant who completes validated study instruments. We hypothesized that mid-trial informant replacement impacts study data in industry-sponsored trials.
methodsWe conducted a retrospective analysis of two industry-sponsored AD clinical trials testing semagacestat in mild-to-moderate AD dementia. We assessed the relationships between informant replacement and Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) scores. Using generalized estimating equations, we assessed bias and variability using mean (bias) and mean absolute (variance) change in ADCS-ADL between successive visits as outcomes. Both models adjusted for a priori-specified potential confounding variables including participant sex, age, informant type, trial, time, previous ADCS-ADL score, and region. To analyze the impact on end-of-study change-from-baseline results, we used an analysis of covariance model to estimate the association between replacement and end-of-study change-from-baseline in ADCS-ADL, in which we adjusted for participant sex, age, informant type, trial, baseline measurement, and region. We conducted an
resultsAmong DISCUSSION: Informant replacement was associated with increased between-visit variability but had limited impact on overall trial outcomes. Highlights: Informant replacement occurred in 2.6% of participants in these industry trials.Informant replacement was associated with increased variance in acute Alzheimer's Disease Cooperative Study Activities of Daily Living reporting.Informant replacement had a limited impact on overall change-from-baseline outcomes.
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