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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Agitation, Dementia

In brief

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.

Key facts

Study ID

NCT05665088

Run by

BioXcel Therapeutics Inc

People needed

13

Starts

2022-12-14

Expected to finish

2023-09-11

Last updated by the study team

2023-12-11

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 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.
• Subjects with a potential cause for delirium (relatively recent onset agitation and dementia)

Where it is running

• 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

Full record on ClinicalTrials.gov

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