Journal
ALZHEIMERS & DEMENTIA
Volume 16, Issue 5, Pages 797-803Publisher
WILEY
DOI: 10.1002/alz.12058
Keywords
Alzheimer's; clinical trials; concurrent medication; intercurrent events; symptomatic medication
Categories
Funding
- National Institute on Aging [R01-AG049750]
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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.
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