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

Recruiting · NCT06808984 · Interventional (participants receive a specific treatment) · Lead sponsor: Celgene

View the official record on ClinicalTrials.gov →

Interventions studied

BMS-986368Placebo

What this trial is about

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.

Who can take part

Age range

55 Years to 90 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

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.

Where it is running

60 locations listed across 24 US states.

Local Institution - 0046 - Homewood, Alabama, United States
University of Alabama - Huntsville Regional Medical Campus - Huntsville, Alabama, United States
Local Institution - 0048 - Phoenix, Arizona, United States
Local Institution - 0040 - Scottsdale, Arizona, United States
Local Institution - 0017 - Anaheim, California, United States
Inland Psychiatric Medical Group. - 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
Local Institution - 0043 - Sherman Oaks, California, United States
Next Level Clinical Trials - West Covina, California, United States
Local Institution - 0028 - West Hills, California, United States
University of Colorado Anschutz Medical Campus - Aurora, Colorado, United States
Georgetown University - Washington D.C., District of Columbia, 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
Local Institution - 0010 - Miami, Florida, United States
Local Institution - 0001 - Tampa, Florida, United States
Local Institution - 0080 - Tampa, Florida, United States
Charter Research - Lady Lake - The Villages, Florida, United States
Local Institution - 0026 - Atlanta, Georgia, United States
CenExel iResearch, LLC - Decatur, Georgia, United States
CenExel iResearch, LLC - Savannah, Georgia, United States
Local Institution - 0004 - Honolulu, Hawaii, United States
Local Institution - 0086 - Elgin, Illinois, United States
Local Institution - 0011 - Marrero, Louisiana, United States
K2 Medical Research - Foxborough, Massachusetts, United States
Local Institution - 0051 - South Dartmouth, Massachusetts, United States
Local Institution - 0088 - Sterling Heights, Michigan, United States
Boeson Research - Missoula, Montana, United States
Be Well Clinical Studies - Omaha - Omaha, Nebraska, United States
Local Institution - 0041 - Las Vegas, Nevada, United States
Local Institution - 0059 - Livingston, New Jersey, United States
Local Institution - 0081 - Toms River, 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
Local Institution - 0064 - 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
Local Institution - 0087 - Columbus, Ohio, United States
Local Institution - 0089 - Ardmore, Oklahoma, United States
Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience - Philadelphia, Pennsylvania, 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
Local Institution - 0024 - Flower Mound, Texas, United States
Local Institution - 0020 - Houston, Texas, United States
Stryde Research - Plano - Plano, Texas, United States
Local Institution - 0091 - Richardson, Texas, United States
Be Well Clinical Studies - Round Rock, Texas, United States
Boeson Research - Provo - Provo, Utah, United States

Showing 60 of 78 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →