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Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

Description

This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.

Conditions

AgitationAlzheimer Disease
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Related Conditions:

AgitationAlzheimer Disease

Study Overview

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Study Details

Study overview

This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.

A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)

Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

Condition
Agitation
Intervention / Treatment

-

Contacts and Locations

Homewood

Local Institution - 0046, Homewood, Alabama, United States, 35209

Huntsville

Local Institution - 0036, Huntsville, Alabama, United States, 35801

Phoenix

Local Institution - 0048, Phoenix, Arizona, United States, 85016

Scottsdale

Local Institution - 0040, Scottsdale, Arizona, United States, 85260

Anaheim

Local Institution - 0017, Anaheim, California, United States, 92805

Chino

Inland Psychiatric Medical Group - Chino, Chino, California, United States, 91710

La Jolla

Local Institution - 0018, La Jolla, California, United States, 92037

La Jolla

Local Institution - 0052, La Jolla, California, United States, 92037

Lakewood

Shreenath Clinical Service - Lakewood, Lakewood, California, United States, 90805

Sherman Oaks

Local Institution - 0043, Sherman Oaks, California, United States, 91403

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD: Alzheimer's Association Workgroup.
  • * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.
  • * History of agitation with onset at least four weeks prior to Screening
  • * MMSE-1 score \< 21
  • * NPI-NH agitation/aggression sub-score ≥ 4.
  • * Stable living environment for at least 6 weeks prior to Screening. Participants are eligible if they are in nursing homes, assisted living facilities, or living at home and have an identified study partner (caregiver).
  • * Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.
  • * Clinically significant delusions/hallucinations requiring hospitalization.
  • * History of bipolar disorder, schizophrenia, or schizoaffective disorder.
  • * History of major depressive episode with psychotic features during the 12 months prior to Screening.
  • * History of delirium within 30 days of Screening.
  • * Other protocol-defined Inclusion/Exclusion criteria apply.

Ages Eligible for Study

55 Years to 90 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Celgene,

Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

2027-09-08