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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
Sponsor: Celgene
Summary
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)
Key Details
Gender
All
Age Range
55 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-06-09
Completion Date
2028-01-07
Last Updated
2026-04-09
Healthy Volunteers
No
Conditions
Interventions
BMS-986368
Specified dose on specified days
Placebo
Specified dose on specified days
Locations (52)
Local Institution - 0046
Homewood, Alabama, United States
University of Alabama - Huntsville Regional Medical Campus
Huntsville, Alabama, United States
NoesisPharma
Phoenix, Arizona, United States
Local Institution - 0040
Scottsdale, Arizona, United States
Local Institution - 0017
Anaheim, California, United States
Inland Psychiatric Medical Group - Chino
Chino, California, United States
Kaizen Brain Center
La Jolla, California, United States
University of California San Diego - La Jolla
La Jolla, California, United States
Shreenath Clinical Service - Lakewood
Lakewood, California, United States
Accellacare - Sherman Oaks
Sherman Oaks, California, United States
Next Level Clinical Trials
West Covina, California, United States
Alliance Clinical -West Hills
West Hills, California, United States
Local Institution - 0066
Aurora, Colorado, United States
Local Institution - 0053
Washington D.C., District of Columbia, United States
Arrow Clinical Trials
Daytona Beach, Florida, United States
ClinCloud
Maitland, Florida, United States
Local Institution - 0007
Maitland, Florida, United States
Local Institution - 0022
Miami, Florida, United States
Ocean Blue Medical Research Center
Miami, Florida, United States
Local Institution - 0001
Tampa, Florida, United States
Charter Research - Lady Lake
The Villages, Florida, United States
Advanced Discovery Research
Atlanta, Georgia, United States
CenExel iResearch, LLC
Decatur, Georgia, United States
CenExel iResearch, LLC
Savannah, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Local Institution - 0011
Marrero, Louisiana, United States
Local Institution - 0051
South Dartmouth, Massachusetts, United States
Local Institution - 0061
Missoula, Montana, United States
Be Well Clinical Studies - Omaha
Omaha, Nebraska, United States
Oasis Clinical Trials
Las Vegas, Nevada, United States
Local Institution - 0059
Livingston, New Jersey, United States
University at Buffalo - UBMD Neurology
Buffalo, New York, United States
The Feinstein Institute for Medical Research
Manhasset, New York, United States
Mid Hudson Medical Research
New Windsor, New York, United States
Hawthorne Health - Super Health Staten Island
Staten Island, New York, United States
Research Central LLC (DBA Ichor Research)
Syracuse, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
UNC Health REX Hospital
Raleigh, North Carolina, United States
Cleveland Clinic
Cleveland, Ohio, United States
Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience
Philadelphia, Pennsylvania, United States
K2 Medical Research - East Providence
East Providence, Rhode Island, United States
Local Institution - 0031
Chattanooga, Tennessee, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Vanderbilt University Medical Center- Village
Nashville, Tennessee, United States
Pinnacle Clinical Research
Austin, Texas, United States
Horizon Clinical Research Center - Houston
Cypress, Texas, United States
ANESC Research
El Paso, Texas, United States
North Pointe Psychiatry - Flower Mound
Flower Mound, Texas, United States
Local Institution - 0020
Houston, Texas, United States
Stryde Research - Plano
Plano, Texas, United States
Be Well Clinical Studies
Round Rock, Texas, United States
Boeson Research - Provo
Provo, Utah, United States