RecruitingRecruiting
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
NCT06808984 · Celgene
In plain English
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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)
About this study
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.
Eligibility criteria
Inclusion 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 ≤24.
* 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.
Exclusion Criteria
* 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.
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: triple
Age groups: adult, older_adult
Timeline
Starts: 2025-06-09
Estimated completion: 2028-01-07
Last updated: 2026-09-01
Interventions
Drug: BMS-986368Drug: Placebo
Primary outcomes
- • Change in Cohen-Mansfield Agitation Inventory (CMAI) total score from baseline (Up to Week 8)
Sponsor
Celgene · industry
Contacts & investigators
ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.com · contact · Clinical.Trials@bms.com · 855-907-3286
ContactFirst line of the email MUST contain NCT # and Site #. · contact
InvestigatorBristol-Myers Squibb · study_director, Bristol-Myers Squibb
All locations (78)
Local Institution - 0046Not Yet Recruiting
Homewood, Alabama, United States
University of Alabama - Huntsville Regional Medical CampusRecruiting
Huntsville, Alabama, United States
Local Institution - 0048Completed
Phoenix, Arizona, United States
Local Institution - 0040Not Yet Recruiting
Scottsdale, Arizona, United States
Local Institution - 0017Not Yet Recruiting
Anaheim, California, United States
Inland Psychiatric Medical Group.Recruiting
Chino, California, United States
Kaizen Brain CenterRecruiting
La Jolla, California, United States
University of California San Diego - La JollaRecruiting
La Jolla, California, United States
Shreenath Clinical Service - LakewoodRecruiting
Lakewood, California, United States
Local Institution - 0043Completed
Sherman Oaks, California, United States
Next Level Clinical TrialsRecruiting
West Covina, California, United States
Local Institution - 0028Completed
West Hills, California, United States
University of Colorado Anschutz Medical CampusRecruiting
Aurora, Colorado, United States
Georgetown UniversityRecruiting
Washington D.C., District of Columbia, United States
Local Institution - 0053Withdrawn
Washington D.C., District of Columbia, United States
Arrow Clinical TrialsRecruiting
Daytona Beach, Florida, United States
ClinCloudRecruiting
Maitland, Florida, United States
Local Institution - 0007Not Yet Recruiting
Maitland, Florida, United States
Local Institution - 0022Withdrawn
Miami, Florida, United States
Local Institution - 0010Completed
Miami, Florida, United States
Local Institution - 0001Not Yet Recruiting
Tampa, Florida, United States
Local Institution - 0080Not Yet Recruiting
Tampa, Florida, United States
Charter Research - Lady LakeRecruiting
The Villages, Florida, United States
Local Institution - 0026Completed
Atlanta, Georgia, United States
CenExel iResearch, LLCRecruiting
Decatur, Georgia, United States
CenExel iResearch, LLCRecruiting
Savannah, Georgia, United States
Local Institution - 0004Completed
Honolulu, Hawaii, United States
Local Institution - 0086Withdrawn
Elgin, Illinois, United States
Local Institution - 0011Not Yet Recruiting
Marrero, Louisiana, United States
K2 Medical ResearchRecruiting
Foxborough, Massachusetts, United States
Local Institution - 0051Not Yet Recruiting
South Dartmouth, Massachusetts, United States
Local Institution - 0088Not Yet Recruiting
Sterling Heights, Michigan, United States
Boeson ResearchRecruiting
Missoula, Montana, United States
Be Well Clinical Studies - OmahaRecruiting
Omaha, Nebraska, United States
Local Institution - 0041Completed
Las Vegas, Nevada, United States
Local Institution - 0059Not Yet Recruiting
Livingston, New Jersey, United States
Local Institution - 0081Not Yet Recruiting
Toms River, New Jersey, United States
University at Buffalo - UBMD NeurologyRecruiting
Buffalo, New York, United States
The Feinstein Institute for Medical ResearchRecruiting
Manhasset, New York, United States
Mid Hudson Medical ResearchRecruiting
New Windsor, New York, United States
Local Institution - 0064Completed
Staten Island, New York, United States
Research Central LLC (DBA Ichor Research)Recruiting
Syracuse, New York, United States
New Hope Clinical ResearchRecruiting
Charlotte, North Carolina, United States
UNC Health REX HospitalRecruiting
Raleigh, North Carolina, United States
Cleveland ClinicRecruiting
Cleveland, Ohio, United States
Local Institution - 0087Not Yet Recruiting
Columbus, Ohio, United States
Local Institution - 0089Not Yet Recruiting
Ardmore, Oklahoma, United States
Thomas Jefferson University - Vickie & Jack Farber Institute for NeuroscienceRecruiting
Philadelphia, Pennsylvania, United States
Local Institution - 0031Not Yet Recruiting
Chattanooga, Tennessee, United States
Neurology Clinic, P.C.Recruiting
Cordova, Tennessee, United States
Vanderbilt University Medical Center- VillageRecruiting
Nashville, Tennessee, United States
Pinnacle Clinical ResearchRecruiting
Austin, Texas, United States
Horizon Clinical Research Center - HoustonRecruiting
Cypress, Texas, United States
ANESC ResearchRecruiting
El Paso, Texas, United States
Local Institution - 0024Completed
Flower Mound, Texas, United States
Local Institution - 0020Withdrawn
Houston, Texas, United States
Stryde Research - PlanoRecruiting
Plano, Texas, United States
Local Institution - 0091Not Yet Recruiting
Richardson, Texas, United States
Be Well Clinical StudiesRecruiting
Round Rock, Texas, United States
Boeson Research - ProvoRecruiting
Provo, Utah, United States
Local Institution - 0068Not Yet Recruiting
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution - 0071Not Yet Recruiting
Mar del Plata, Buenos Aires, Argentina
Local Institution - 0074Not Yet Recruiting
Córdoba, Córdoba Province, Argentina
Local Institution - 0069Not Yet Recruiting
Buenos Aires, Argentina
Local Institution - 0075Not Yet Recruiting
Córdoba, Argentina
Local Institution - 0072Not Yet Recruiting
Mendoza, Argentina
Local Institution - 0073Not Yet Recruiting
Santiago del Estero, Argentina
Local Institution - 0076Not Yet Recruiting
Macquarie Park, New South Wales, Australia
Local Institution - 0090Not Yet Recruiting
Daw Park, South Australia, Australia
Local Institution - 0079Not Yet Recruiting
Wangaratta, Victoria, Australia
Local Institution - 0078Not Yet Recruiting
Nedlands, Western Australia, Australia
Local Institution - 0077Not Yet Recruiting
Darlinghurst, Australia
Local Institution - 0084Not Yet Recruiting
Hefei, Anhui, China
Local Institution - 0092Not Yet Recruiting
Beijing, Beijing Municipality, China
Local Institution - 0093Not Yet Recruiting
Wuhan, HUB, China
Local Institution - 0085Not Yet Recruiting
Nanjing, Jiangsu, China
Local Institution - 0082Not Yet Recruiting
Shanghai Shi, Shanghai Municipality, China
Local Institution - 0083Not Yet Recruiting
Hangzhou, Zhejiang, China