Initiation of symptomatic medication in Alzheimer's disease clinical trials: Hypothetical versus treatment policy approach. Issue 5 (8th April 2020)

• Record Type: Journal Article
• Authors: Donohue, Michael C.; Model, Fabian; Delmar, Paul; Volye, Nicola; Liu‐Seifert, Hong; Rafii, Michael S.; Aisen, Paul S.
• Is Part Of: Alzheimer's & dementia. Volume 16:Issue 5(2020)
• Page Start: 797
• Page End: 803
• Publication Date: 2020-04-08
• Subjects: Alzheimer's -- clinical trials -- concurrent medication -- intercurrent events -- symptomatic medication; Alzheimer's disease -- Periodicals; Alzheimer Disease -- Periodicals; Dementia -- Periodicals; Démence; Maladie d'Alzheimer; Périodique électronique (Descripteur de forme); Ressource Internet (Descripteur de forme); 616.83
• DOI: 10.1002/alz.12058
• Languages: English
• ISSNs: 1552-5260

Abstract

Abstract: In clinical trials in populations with mild cognitive impairment, it is common for participants to initiate concurrent symptomatic medications for Alzheimer's disease after randomization to the experimental therapy. One strategy for addressing this occurrence is to exclude any observations that occur after the concurrent medication is initiated. The rationale for this approach is that these observations might reflect a symptomatic benefit of the concurrent medication that would adversely bias efficacy estimates for an effective experimental therapy. We interrogate the assumptions underlying such an approach by estimating the effect of newly prescribed concurrent medications in an observational study, the Alzheimer's Disease Neuroimaging Initiative.