Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)
NCT ID: NCT05665088
Last Updated: 2023-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
13 participants
INTERVENTIONAL
2022-12-14
2023-09-11
Brief Summary
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Detailed Description
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Approximately 150 subjects will participate in this study. Subjects will receive a single film consisting of BXCL501 40 µg dose or BXCL501 60 µg dose or placebo. Subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1- 40 Micrograms
Sublingual film containing 40 Micrograms Dexmedetomidine
BXCL501
Sublingual Film
Cohort 2- 60 Micrograms
Sublingual film containing 60 Micrograms Dexmedetomidine
BXCL501
Sublingual Film
Placebo
Sublingual Placebo film
Matching Placebo
Sublingual Placebo Film
Interventions
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BXCL501
Sublingual Film
Matching Placebo
Sublingual Placebo Film
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Episodes of psychomotor agitation (e.g., kick, bite, flailing)
3. Subjects exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject'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. Subjects who read, understand, and provide written informed consent, or who have a LAR to provide consent on their behalf
6. Subjects 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
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. Subjects with agitation caused by acute intoxication.
4. Subjects with significant risk of suicide or homicide per the investigator's assessment.
5. 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.
6. History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years, current evidence of hypovolemia, orthostatic hypotension, bradycardia.
7. Subjects with laboratory or ECG abnormalities.
8. Subjects who have received an investigational drug within 30 days prior to Screening.
9. Subjects who are currently suffering from substance abuse.
10. Subjects with a potential cause for delirium (relatively recent onset agitation and dementia)
65 Years
ALL
No
Sponsors
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Cognitive Research Corporation
INDUSTRY
BioXcel Therapeutics Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Risinger, MD
Role: STUDY_CHAIR
BioXcel Therapeutics
Locations
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BioXcel Clinical Research Site
Los Alamitos, California, United States
BioXcel Clinical Research Site
Daytona Beach, Florida, United States
BioXcel Clinical Research Site
Maitland, Florida, United States
BioXcel Clinical Research Site
The Villages, Florida, United States
BioXcel Clinical Research Site
Marrero, Louisiana, United States
BioXcel Clinical Research Site
Springfield, Massachusetts, United States
BioXcel Clinical Research Site
Toms River, New Jersey, United States
Countries
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Other Identifiers
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BXCL501-304
Identifier Type: -
Identifier Source: org_study_id