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

Primary Purpose

Agitation, Dementia

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
BXCL501
Matching Placebo
Sponsored by
BioXcel Therapeutics Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Agitation

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. All subjects must have a diagnosis of probable AD based on NIA-AA criteria (2018)
  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 15 to 23 on the Mini-Mental State Exam (MMSE)
  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 who had a total score of >13 (ie, high fall risk) on the John Hopkins Fall Risk Assessment Tool.
  8. Subjects with laboratory or ECG abnormalities.
  9. Subjects who have received an investigational drug within 30 days prior to Screening.
  10. Subjects who are currently suffering from substance abuse. Patients with a potential cause for delirium (relatively recent onset agitation and dementia)

Sites / Locations

  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site
  • BioXcel Clinical Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1- 40 Micrograms

Cohort 2- 60 Micrograms

Placebo

Arm Description

Sublingual film containing 40 Micrograms Dexmedetomidine

Sublingual film containing 60 Micrograms Dexmedetomidine

Sublingual Placebo film

Outcomes

Primary Outcome Measures

Absolute 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)

Secondary Outcome Measures

Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the 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)
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the 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)
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for all episodes 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)

Full Information

First Posted
February 28, 2022
Last Updated
July 25, 2023
Sponsor
BioXcel Therapeutics Inc
Collaborators
Cognitive Research Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05271552
Brief Title
Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)
Official Title
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Efficacy And Safety Study of PRN Dosing of BXCL501 Over A 12 Week Period In Subjects With Agitation Associated With Dementia
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
April 21, 2023 (Actual)
Study Completion Date
April 21, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
BioXcel Therapeutics Inc
Collaborators
Cognitive Research Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 28 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. Subjects will be dosed PRN with a maximum of 28 doses over a 12-week period. Once a subject has received 28 doses of BXCL501, they will continue to be followed for the remainder of the 12-week study period. 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 in a 1:1:1 randomization scheme. Subjects must reside in a care facility where all study-related procedures and study drug dosing will be performed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Agitation, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized
Masking
InvestigatorOutcomes Assessor
Masking Description
Double-Blinded
Allocation
Randomized
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1- 40 Micrograms
Arm Type
Experimental
Arm Description
Sublingual film containing 40 Micrograms Dexmedetomidine
Arm Title
Cohort 2- 60 Micrograms
Arm Type
Experimental
Arm Description
Sublingual film containing 60 Micrograms Dexmedetomidine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Sublingual Placebo film
Intervention Type
Drug
Intervention Name(s)
BXCL501
Other Intervention Name(s)
Dexmedetomidine
Intervention Description
Sublingual Film
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Other Intervention Name(s)
Placebo
Intervention Description
Sublingual Placebo Film
Primary Outcome Measure Information:
Title
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) total score
Description
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)
Time Frame
120 minutes
Secondary Outcome Measure Information:
Title
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the first episode of agitation
Description
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)
Time Frame
30 minutes
Title
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for the first episode of agitation
Description
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)
Time Frame
60 minutes
Title
Absolute change from baseline in Positive and Negative Syndrome Scale- Excited for all episodes of agitation
Description
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)
Time Frame
120 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Risinger, MD
Organizational Affiliation
BioXcel Therapeutics
Official's Role
Study Chair
Facility Information:
Facility Name
BioXcel Clinical Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Daytona Beach
State/Province
Florida
ZIP/Postal Code
32117
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Lady Lake
State/Province
Florida
ZIP/Postal Code
32159
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
BioXcel Clinical Research Site
City
North Miami
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01103
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Facility Name
BioXcel Clinical Research Site
City
Toms River
State/Province
New Jersey
ZIP/Postal Code
08755
Country
United States

12. IPD Sharing Statement

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

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