An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

NCT05276830 | Terminated Phase 2 Results FDA Drug

• 1 other identifier: BXCL501-203
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation associated with all forms of dementia (i.e., probably Alzheimer's Disease, vascular dementia; mixed; frontotemporal dementia) excluding Parkinson's-Related Dementia and Lewy Body Dementia.

Conditions

Agitation; Dementia

Outcome Measures

Primary Outcomes (1)

• Change 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

Secondary Outcomes (3)

• Change From Baseline for Pittsburgh Agitation Scale

  120 minutes

• Change From Baseline for Agitation-Calmness Evaluation Scale

  120 minutes

• Clinical Global Impression - Improvement

  120 minutes

Study Arms (3)

40 micrograms

EXPERIMENTAL

Sublingual film containing 40 micrograms Dexmedetomidine

Drug: BXCL501

60 micrograms

EXPERIMENTAL

Sublingual film containing 60 micrograms Dexmedetomidine

Drug: BXCL501

Placebo

EXPERIMENTAL

Sublingual Placebo film

Drug: Placebo film

Interventions

BXCL501 DRUG

Sublingual film containing 40 Micrograms BXCL501

Also known as: Dexmedetomidine

40 micrograms

Placebo film DRUG

Matching Sublingual Placebo film

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Individuals diagnosed with any form of dementia (i.e., probable Alzheimer's Disease; vascular dementia; mixed; frontotemporal dementia)
• Subjects who have met DSM-5 criteria for dementia (major neurocognitive disorder) who have instances of acute psychomotor agitation.
• History of psychomotor agitation (e.g., kick, bite, flailing) to the point that it impairs social activities, requires staffing, or medical intervention, or impairs ability for functional activities of daily living.
• Subjects are expected to exhibit behaviors that are congruent with the International Psychogeriatric Association criterion for agitation representing a change from the subject's usual behavior.
• Subjects who have a score of ≤16 on the Mini-Mental State Exam (MMSE).
• Subjects with a remote (\>5 years) history of stroke may be included, regardless of size/location.
• Subjects who read, understand, and provide written informed consent, or who have a legally authorized representative (LAR).
• Subjects who are deemed to be medically appropriate for study participation by the principal investigator.
• Subjects who are at their current location for at least 14 days before screening and plan to remain at the same location for the duration of the study.
• Subjects who have the capability to participate in the study and self-administer the investigational product.
• Subjects who are on a stable concomitant medications regimen for the treatment of any concurrent conditions for at least one month prior to the screening visit.

You may not qualify if:

• Subjects who have dementia associated with Parkinson's disease and/or Lewy Body Disease are excluded.
• Subjects suffering from alcohol and/or substance abuse.
• Subjects with agitation caused by acute intoxication must be excluded.
• Subjects with significant risk of suicide or homicide per the investigator's assessment.
• Subjects who have hydrocephalus, seizure disorder, or history of significant head trauma, subarachnoid bleeding, brain tumor, encephalopathy, meningitis, or focal neurological findings, with a recent (1 year) large (non-microvascular) stroke who may be considered medically unstable or in recovery must be excluded.
• History of clinically significant syncope or syncopal attacks, orthostatic hypotension within the past 2 years.
• Subjects with laboratory or ECG abnormalities.
• Subjects with serious, unstable, or uncontrolled medical illnesses must be excluded.
• Subjects who have received an investigational drug within 30 days prior to Screening must be excluded.
• Subjects who are considered by the investigator, for any reason, to be an unsuitable candidate for receiving dexmedetomidine must be excluded.
• Subjects whose agitation is attributed to pain or infection, delirium, concomitant medications, environmental conditions, or another psychiatric condition or medical condition as determined by the investigator.

Sponsors & Collaborators

• BioXcel Therapeutics Inc: lead
• Cognitive Research Corporation: collaborator

Study Sites (3)

Bioxcel Clinical Research Site

North Miami, Florida, 33161, United States

Location

Bioxcel Clinical Research Site

Springfield, Massachusetts, 01103, United States

Location

BioXcel Clinical Research Site

Toms River, New Jersey, 08755, United States

Location

MeSH Terms

Conditions

Psychomotor Agitation; Dementia

Interventions

Dexmedetomidine

Condition Hierarchy (Ancestors)

Dyskinesias; Neurologic Manifestations; Nervous System Diseases; Psychomotor Disorders; Neurobehavioral Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Aberrant Motor Behavior in Dementia; Behavioral Symptoms; Behavior; Brain Diseases; Central Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was terminated prematurely due to business reasons. There were no Safety or Efficacy Concerns.

Results Point of Contact

• Title: Vice President Head of Clinical Operations
• Organization: BioXcel Therapeutics

cgommoll@bioxceltherapeutics.com

(475) 355 5177

Study Officials

• Robert Risinger, MD

  BioXcel Therapeutics

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-Blind, Placebo controlled
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Study will randomize subjects 1:1:1 to receive BXCL501 40 μg, BXCL501 60 μg, or matching placebo film

Study Record Dates

• First Submitted: February 28, 2022
• First Posted: March 11, 2022
• Study Start: February 8, 2022
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: August 25, 2023
• Results First Posted: August 25, 2023

Record last verified: 2023-08

Locations

US (3)