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

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

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.

Study Overview

• Status: Completed
• Conditions: Dementia; Agitation
• Intervention / Treatment: Drug: BXCL501; Drug: Matching Placebo

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.

• Study Type: Interventional
• Enrollment (Actual): 151
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • BioXcel Clinical Research Site
  • California
    • Long Beach, California, United States, 90806
      • BioXcel Clinical Research Site
  • Florida
    • Daytona Beach, Florida, United States, 32117
      • BioXcel Clinical Research Site
    • Lady Lake, Florida, United States, 32159
      • BioXcel Clinical Research Site
    • Maitland, Florida, United States, 32751
      • BioXcel Clinical Research Site
    • Miami Lakes, Florida, United States, 33016
      • BioXcel Clinical Research Site
    • North Miami, Florida, United States, 33161
      • BioXcel Clinical Research Site
  • Louisiana
    • Marrero, Louisiana, United States, 70072
      • BioXcel Clinical Research Site
  • Massachusetts
    • Springfield, Massachusetts, United States, 01103
      • BioXcel Clinical Research Site
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • BioXcel Clinical Research Site
    • Toms River, New Jersey, United States, 08755
      • BioXcel Clinical Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort 1- 40 Micrograms; Sublingual film containing 40 Micrograms Dexmedetomidine	Drug: BXCL501; Sublingual Film; Other Names: Dexmedetomidine
Experimental: Cohort 2- 60 Micrograms; Sublingual film containing 60 Micrograms Dexmedetomidine	Drug: BXCL501; Sublingual Film; Other Names: Dexmedetomidine
Placebo Comparator: Placebo; Sublingual Placebo film	Drug: Matching Placebo; Sublingual Placebo Film; Other Names: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absolute Change From Baseline in Positive and Negative Syndrome Scale- Excited Component (PEC) Total Score 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)	120 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	30 minutes
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)	60 minutes
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)	120 minutes

Collaborators and Investigators

• Sponsor: BioXcel Therapeutics Inc
• Collaborators: Cognitive Research Corporation
• Investigators: Study Chair: Robert Risinger, MD, BioXcel Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2022
• Primary Completion (Actual): April 21, 2023
• Study Completion (Actual): April 21, 2023

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: February 28, 2022
• First Posted (Actual): March 9, 2022

Study Record Updates

• Last Update Posted (Actual): December 31, 2025
• Last Update Submitted That Met QC Criteria: December 11, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Aberrant Motor Behavior in Dementia; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Neurobehavioral Manifestations; Neurocognitive Disorders; Dyskinesias; Psychomotor Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Dementia; Psychomotor Agitation; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azoles; Imidazoles; Dexmedetomidine
• Other Study ID Numbers: BXCL501-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No