Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III) (NCT05665088) | Clinical Trial Compass
TerminatedPhase 3
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY III)
Stopped: Study was terminated for business reasons; not due to safety or efficacy concerns
United States13 participantsStarted 2022-12-14
Plain-language 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.
Who can participate
Age range65 Years
SexALL
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Inclusion criteria
✓. All subjects must have a diagnosis of probable Alzheimer's disease based on NIA-AA criteria (2018). If subject 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
✓. 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 0 to 20 on the Mini-Mental State Exam (MMSE) and require moderate to full assistance with activities of daily living
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score
Timeframe: 120 minutes post-dose for first episode of agitation
. 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 with laboratory or ECG abnormalities.
✕. Subjects who have received an investigational drug within 30 days prior to Screening.