RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2025-06-09
Study Completion:2027-09-08
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06808984

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.

Ages Eligible for Study:55 Years to 90 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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.
  2. * The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.
  3. * History of agitation with onset at least four weeks prior to Screening
  4. * MMSE-1 score \< 21
  5. * NPI-NH agitation/aggression sub-score ≥ 4.
  6. * 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).
  7. * Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.
  1. * Clinically significant delusions/hallucinations requiring hospitalization.
  2. * History of bipolar disorder, schizophrenia, or schizoaffective disorder.
  3. * History of major depressive episode with psychotic features during the 12 months prior to Screening.
  4. * History of delirium within 30 days of Screening.
  5. * Other protocol-defined Inclusion/Exclusion criteria apply.

Contacts and Locations

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACT
8559073286
Clinical.Trials@bms.com
First line of the email MUST contain the NCT# and Site #.
CONTACT

Principal Investigator

Bristol-Myers Squibb
STUDY_DIRECTOR
Bristol-Myers Squibb

Study Locations (Sites)

Local Institution - 0046
Homewood, Alabama, 35209
United States
Local Institution - 0036
Huntsville, Alabama, 35801
United States
Local Institution - 0048
Phoenix, Arizona, 85016
United States
Local Institution - 0040
Scottsdale, Arizona, 85260
United States
Local Institution - 0017
Anaheim, California, 92805
United States
Inland Psychiatric Medical Group - Chino
Chino, California, 91710
United States
Local Institution - 0018
La Jolla, California, 92037
United States
Local Institution - 0052
La Jolla, California, 92037
United States
Shreenath Clinical Service - Lakewood
Lakewood, California, 90805
United States
Local Institution - 0043
Sherman Oaks, California, 91403
United States
Local Institution - 0057
West Covina, California, 91790
United States
Local Institution - 0028
West Hills, California, 91307
United States
Local Institution - 0053
Washington, District of Columbia, 20060
United States
Arrow Clinical Trials
Daytona Beach, Florida, 32117
United States
ClinCloud
Maitland, Florida, 32751
United States
Local Institution - 0007
Maitland, Florida, 32751
United States
Local Institution - 0022
Miami, Florida, 33125
United States
Local Institution - 0010
Miami, Florida, 33166
United States
Local Institution - 0001
Tampa, Florida, 33607
United States
Local Institution - 0039
The Villages, Florida, 32162
United States
Advanced Discovery Research
Atlanta, Georgia, 30318
United States
Local Institution - 0035
Decatur, Georgia, 30030
United States
Local Institution - 0015
Savannah, Georgia, 31405
United States
Local Institution - 0004
Honolulu, Hawaii, 96817
United States
Local Institution - 0011
Marrero, Louisiana, 70072
United States
Local Institution - 0051
South Dartmouth, Massachusetts, 02747
United States
Local Institution - 0041
North Las Vegas, Nevada, 89030
United States
Local Institution - 0034
Buffalo, New York, 14203
United States
Local Institution - 0049
Manhasset, New York, 11030
United States
Local Institution - 0021
Syracuse, New York, 13210
United States
Local Institution - 0016
Charlotte, North Carolina, 28211
United States
Local Institution - 0023
Cleveland, Ohio, 44195
United States
Local Institution - 0025
East Providence, Rhode Island, 02914
United States
Local Institution - 0031
Chattanooga, Tennessee, 37421
United States
Local Institution - 0019
Cordova, Tennessee, 38018
United States
Local Institution - 0033
Nashville, Tennessee, 37212
United States
Local Institution - 0042
Cypress, Texas, 77429
United States
Local Institution - 0045
El Paso, Texas, 79912
United States
Local Institution - 0024
Flower Mound, Texas, 75028
United States
Local Institution - 0020
Houston, Texas, 77030
United States
Local Institution - 0038
Round Rock, Texas, 78681
United States
Local Institution - 0027
Provo, Utah, 84604
United States

Collaborators and Investigators

Sponsor: Celgene

  • Bristol-Myers Squibb, STUDY_DIRECTOR, Bristol-Myers Squibb

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-06-09
Study Completion Date2027-09-08

Study Record Updates

Study Start Date2025-06-09
Study Completion Date2027-09-08

Terms related to this study

Additional Relevant MeSH Terms

  • Agitation
  • Alzheimer Disease