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TERMINATED

NCT05665088

PHASE3

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)

Sponsor: BioXcel Therapeutics Inc

View on ClinicalTrials.gov

Summary

A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed \[PRN\]), for a maximum of 168 doses within a 12-week treatment period.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia Who Require at Least Moderate To Full Assistance With Activities of Daily Living

Key Details

Gender

All

Age Range

65 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2022-12-05

Completion Date

2023-09-11

Last Updated

2026-10-01

Healthy Volunteers

Conditions

Agitation Dementia

Interventions

DRUG

BXCL501

Solid-dose film administered sublingually or buccally

DRUG

Matching Placebo

Matching solid-dose film administered sublingually or buccally

Inclusion Criteria: 1. All participants must have a diagnosis of probable Alzheimer's disease (AD) based on National Institute on Aging and Alzheimer's Association (NIA-AA) criteria (2018). If participant biomarker data are unavailable, per the 2018 NIA-AA diagnostic criteria, the clinical diagnosis of probable AD will be based on the 2011 NIA-AA criteria 2. Episodes of psychomotor agitation (e.g., kick, bite, flailing) 3. Participants exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the participant's usual behavior 4. A score of 0 to 20 on the Mini-Mental State Exam (MMSE) and require moderate to full assistance with activities of daily living 5. Participants who read, understand, and provide written informed consent, or who have a legally authorized representative (LAR) to provide consent on their behalf 6. Participants who are deemed to be medically appropriate for study participation by the principal investigator 7. Participants who agree to use a medically acceptable and effective birth control method Exclusion Criteria: 1. Participants with dementia or other memory impairment not due to probable AD. 2. Clinical diagnosis of probable AD should not be applied when there is evidence of a cerebrovascular incident temporally related to the worsening of cognitive function. 3. Participants with agitation caused by acute intoxication. 4. Participants with significant risk of suicide or homicide per the investigator's assessment. 5. Participants who are medically unstable or in recovery. Note: Participants with a remote (\>5 years) history of stroke may be included, regardless of size/location. 6. History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia. 7. Participants with laboratory or electrocardiogram (ECG) abnormalities. 8. Participants who have received an investigational drug within 30 days prior to Screening. 9. Participants who are currently suffering from substance abuse. 10. Participants with a potential cause for delirium (relatively recent onset agitation and dementia)