Status:
COMPLETED
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
Lead Sponsor:
BioXcel Therapeutics Inc
Collaborating Sponsors:
Cognitive Research Corporation
Conditions:
Agitation
Dementia
Eligibility:
All Genders
65+ years
Phase:
PHASE3
Brief 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 28 doses within a 12-week ...
Detailed Description
A randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of BXCL501 in male and female subjects (65 years and older) with a...
Eligibility Criteria
Inclusion
- All subjects must have a diagnosis of probable AD based on NIA-AA criteria (2018)
- Episodes of psychomotor agitation (e.g., kick, bite, flailing)
- Subjects exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior
- A score of 15 to 23 on the Mini-Mental State Exam (MMSE)
- Subjects who read, understand, and provide written informed consent, or who have a LAR to provide consent on their behalf
- Subjects who are deemed to be medically appropriate for study participation by the principal investigator
- Participants who agree to use a medically acceptable and effective birth control method
Exclusion
- Subjects with dementia or other memory impairment not due to probable AD.
- 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.
- Subjects with agitation caused by acute intoxication.
- Subjects with significant risk of suicide or homicide per the investigator's assessment.
- Subjects who are medically unstable or in recovery. Note: Subjects with a remote (\>5 years) history of stroke may be included, regardless of size/location.
- History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia.
- Subjects who had a total score of \>13 (ie, high fall risk) on the John Hopkins Fall Risk Assessment Tool.
- Subjects with laboratory or ECG abnormalities.
- Subjects who have received an investigational drug within 30 days prior to Screening.
- Subjects who are currently suffering from substance abuse. Patients with a potential cause for delirium (relatively recent onset agitation and dementia)
Key Trial Info
Start Date :
April 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 21 2023
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT05271552
Start Date
April 27 2022
End Date
April 21 2023
Last Update
December 31 2025
Active Locations (11)
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1
BioXcel Clinical Research Site
Phoenix, Arizona, United States, 85016
2
BioXcel Clinical Research Site
Long Beach, California, United States, 90806
3
BioXcel Clinical Research Site
Daytona Beach, Florida, United States, 32117
4
BioXcel Clinical Research Site
Lady Lake, Florida, United States, 32159