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

Completed · 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 28 doses within a 12-week treatment period.

Key facts

Study ID

NCT05271552

Run by

BioXcel Therapeutics Inc

People needed

151

Starts

2022-04-27

Expected to finish

2023-04-21

Last updated by the study team

2025-12-31

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 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

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 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)

Where it is running

• BioXcel Clinical Research Site — Phoenix, Arizona, United States
• BioXcel Clinical Research Site — Long Beach, California, United States
• BioXcel Clinical Research Site — Daytona Beach, Florida, United States
• BioXcel Clinical Research Site — Lady Lake, Florida, United States
• BioXcel Clinical Research Site — Maitland, Florida, United States
• BioXcel Clinical Research Site — Miami Lakes, Florida, United States
• BioXcel Clinical Research Site — North Miami, Florida, United States
• BioXcel Clinical Research Site — Marrero, Louisiana, United States
• BioXcel Clinical Research Site — Springfield, Massachusetts, United States
• BioXcel Clinical Research Site — Berlin, New Jersey, United States
• BioXcel Clinical Research Site — Toms River, New Jersey, United States

Full record on ClinicalTrials.gov

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