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

Phase 3

Terminated

• Conditions: Agitation; Dementia
• Interventions: Drug: BXCL501; Drug: Matching Placebo

• Registration Number: NCT05665088
• Lead Sponsor: BioXcel Therapeutics Inc

Brief 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.

Detailed Description

A randomized, double-blind, placebo-controlled, parallel group, 3-arm study assessing efficacy, safety, and tolerability of two doses of BXCL501 in male and female subjects (65 years and older) with acute psychomotor agitation associated with dementia.

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.

Study Timeline

• Study Start: 2022-12-14
• Study First Submitted: 2022-12-16
• Study First Submitted QC: 2022-12-16
• Study First Posted: 2022-12-27
• Primary Completion: 2023-09-11
• Study Completion: 2023-09-11
• Status Verified: 2023-12
• Disposition First Submitted: 2023-12-04
• Disposition First Posted: 2023-12-06
• Last Update Submitted: 2023-12-08
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

1. 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
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

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Exclusion Criteria

1. Subjects with dementia or other memory impairment not due to probable AD.
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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort 1- 40 Micrograms	BXCL501	Sublingual film containing 40 Micrograms Dexmedetomidine
Cohort 2- 60 Micrograms	BXCL501	Sublingual film containing 60 Micrograms Dexmedetomidine
Placebo	Matching Placebo	Sublingual Placebo film

Primary Outcome Measures

Name	Time	Method
Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score	120 minutes post-dose for first episode of agitation	The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)

Secondary Outcome Measures

Name	Time	Method
Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score	30 minutes post-dose for first episode of agitation	The Positive and Negative Syndrome Scale - Excited Component (PEC) comprises 5 items associated with agitation: poor impulse control, tension, hostility, uncooperativeness, and excitement; each scored 1 (minimum) to 7 (maximum). The PEC, the sum of these 5 subscales, thus ranges from 5 (absence of agitation) to 35 (extremely severe)

Trial Locations

Locations (1)

BioXcel Clinical Research Site; 🇺🇸 Toms River, New Jersey, United States