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

Dementia Clinical Trial

Official title:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy and Safety Study of PRN Dosing of BXCL501 Over a 12 Week Treatment Period in Subjects With Agitation Associated With Dementia

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05665088
• Other study ID #: BXCL501-304
• Status: Terminated
• Phase: Phase 3
• Start date: December 14, 2022
• Est. completion date: September 11, 2023

Study information

• Verified date: December 2023
• Source: BioXcel Therapeutics Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: September 11, 2023
• Est. primary completion date: September 11, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

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)

Related Conditions & MeSH terms

• Agitation
• Dementia
• Psychomotor Agitation

Intervention

Drug:
• BXCL501
Sublingual Film
• Matching Placebo
Sublingual Placebo Film

Locations

Country	Name	City	State
United States	BioXcel Clinical Research Site	Daytona Beach	Florida
United States	BioXcel Clinical Research Site	Los Alamitos	California
United States	BioXcel Clinical Research Site	Maitland	Florida
United States	BioXcel Clinical Research Site	Marrero	Louisiana
United States	BioXcel Clinical Research Site	Springfield	Massachusetts
United States	BioXcel Clinical Research Site	The Villages	Florida
United States	BioXcel Clinical Research Site	Toms River	New Jersey

Sponsors (2)

Lead Sponsor	Collaborator
BioXcel Therapeutics Inc	Cognitive Research Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score	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)	120 minutes post-dose for first episode of agitation
Secondary	Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score	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)	60 minutes post-dose for first episode of agitation
Secondary	Change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score	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)	30 minutes post-dose for first episode of agitation