BioXcel Initiates P-III (TRANQUILITY) Program of BXCL501 for the Acute Treatment of Agitation in Patients with Alzheimer’s Disease
Shots:
- The company initiates P-III (TRANQUILITY II/III) studies to evaluate BXCL501 (40/60mcg) in 300 patients aged ≥65yrs. with AD in assisted living, residential facilities, and nursing homes. Following the completion of TRANQUILITY II/III studies, patients will enroll in an open-label, 52wks. safety study
- The studies are designed to evaluate agitation as measured by changes from baseline in the PEC & PAS total scores. The 1EPs for both studies will be a change in PEC score from baseline measured @2hrs. after the initial & subsequent doses
- The therapy received BTD for agitation associated with dementia & FTD for agitation associated with schizophrenia, bipolar disorders & dementia
Ref: Globe Newswire | Image: Bioexcel
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