NCT05276830

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy, and Safety Study of BXCL501 For The Treatment of Agitation Associated With Dementia

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: BioXcel Therapeutics Inc · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation associated with all forms of dementia (i.e., probably Alzheimer's Disease, vascular dementia; mixed; frontotemporal dementia) excluding Parkinson's-Related Dementia and Lewy Body Dementia.

Detailed description

The study will enroll at least 75 subjects to receive a single film consisting of BXCL501 40 μg dose, BXCL501 60 μg dose, or matching placebo film. Subjects must reside in a residential care facility and must require at least moderate assistance with activities of daily living (e.g., bathing, dressing, and toileting). The subject must be able to self-administer the film to participate in the study. The effects of BXCL 501 on acute agitation will be assessed by the following scales: PEC, PAS, ACES, and CGI-I.

Conditions

• Agitation
• Dementia

Interventions

Type	Name	Description
DRUG	BXCL501	Sublingual film containing 40 Micrograms BXCL501
DRUG	BXCL501	Sublingual film containing 60 Micrograms BXCL501
DRUG	Placebo film	Matching Sublingual Placebo film

Timeline

• Start date: 2022-02-08
• Primary completion: 2022-04-01
• Completion: 2022-04-01
• First posted: 2022-03-11
• Last updated: 2023-08-25
• Results posted: 2023-08-25

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study