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- W2898078722 abstract "Agitation is common in Alzheimer's disease (AD) and a major burden to patients and caregivers. Effective therapies for agitation are needed, combining non-pharmacologic with novel pharmacologic approaches and targeting therapies to appropriate subgroups of this heterogeneous condition. Targeting the serotonin system, we conducted the Citalopram in AD (CitAD) Study, a randomized, double blind, placebo-controlled trial that administered a psychosocial intervention to all randomized participants to the SSRI citalopram at 30mg/day or placebo. In CitAD, racemic citalopram was effective for agitation with 40% of citalopram-treated participants experiencing substantial clinical improvement vs. only 26% on placebo. However, citalopram was associated with cognitive worsening and prolongation of the ECG-QTc interval. In blood concentration models, cognitive and cardiac changes were associated with the R-enantiomer, whereas clinical improvements were primarily associated with the S-enantiomer (escitalopram). We proposed the S-CitAD Study to build on and extend these findings, applying an evidence-based, sequential approach to treating agitation in AD with real world applicability for patients. In this Phase 3 study, we will enroll 589 patients with AD and agitation and employ an adaptive design with a psychosocial intervention administered at the enrollment visit. Patients not showing clinically significant improvement in agitation after 3 weeks will be randomized to drug or placebo. Given the findings of CitAD, we are using escitalopram at a target dose of 15 mg/day instead of the racemic citalopram. We will evaluate the efficacy and safety of escitalopram over 12-weeks (AIM 1). We will also evaluate pre-specified predictors of response suggested by CitAD (AIM 2). Finally, we will follow patients showing significant improvement on the psychosocial intervention to study predictors of response, as well as duration of improvement and frequency, time course, and predictors of subsequent relapse (AIM 3). N/A." @default.
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- W2898078722 date "2018-07-01" @default.
- W2898078722 modified "2023-10-16" @default.
- W2898078722 title "F4‐02‐02: THE S‐CITAD STUDY: TRIAL DESIGN AND METHODS FOR THE S‐CITALOPRAM IN AGITATION TRIAL" @default.
- W2898078722 doi "https://doi.org/10.1016/j.jalz.2018.06.2869" @default.
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