Phase 3
N=151
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
Agitation · Dementia
Bottom Line
View on ClinicalTrials.gov: NCT05271552 ↗Enrolled (actual)
151
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation — -5.7; -7.5; -5.4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- BXCL501 (Drug); Matching Placebo (Drug)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- BioXcel Therapeutics Inc
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score for the First Episode of Agitation |
-5.7; -7.5; -5.4 | — |
| SECONDARY Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation |
-4.2; -6.2; -4.2 | — |
| SECONDARY Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for the First Episode of Agitation |
-4.2; -6.2; -4.2 | — |
| SECONDARY Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited for All Episodes of Agitation |
-5.8; -7.4; -5.2 | — |
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 treatment period.
Eligibility Criteria
Inclusion Criteria
- 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 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.
- 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)
Data sourced from ClinicalTrials.gov (NCT05271552). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.