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

NCT05276830 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2023-08-25

Study results available
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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.

Conditions

Interventions

DRUG

BXCL501

Sublingual film containing 40 Micrograms BXCL501

DRUG

BXCL501

Sublingual film containing 60 Micrograms BXCL501

DRUG

Placebo film

Matching Sublingual Placebo film

Sponsors & Collaborators

  • Cognitive Research Corporation

    collaborator INDUSTRY

  • BioXcel Therapeutics Inc

    lead INDUSTRY

Principal Investigators

  • Robert Risinger, MD · BioXcel Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2022-04-01
Completion
2022-04-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05276830 on ClinicalTrials.gov