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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Agitation, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT06808984

Run by

Celgene

People needed

120

Starts

2025-06-09

Expected to finish

2028-01-07

Last updated by the study team

2026-06-02

Who can join

Age: 55 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

• New Hope Clinical Research — Charlotte, North Carolina, United States (enrolling)
• K2 Medical Research - East Providence — East Providence, Rhode Island, United States (enrolling)
• Be Well Clinical Studies - Omaha — Omaha, Nebraska, United States (enrolling)
• Research Central LLC (DBA Ichor Research) — Syracuse, New York, United States (enrolling)
• UNC Health REX Hospital — Raleigh, North Carolina, United States (enrolling)
• Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience — Philadelphia, Pennsylvania, United States (enrolling)
• University of California San Diego - La Jolla — La Jolla, California, United States (enrolling)
• Boeson Research — Missoula, Montana, United States (enrolling)
• The Feinstein Institute for Medical Research — Manhasset, New York, United States (enrolling)
• Mid Hudson Medical Research — New Windsor, New York, United States (enrolling)
• Inland Psychiatric Medical Group. — Chino, California, United States (enrolling)
• University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (enrolling)
• Kaizen Brain Center — La Jolla, California, United States (enrolling)
• Cleveland Clinic — Cleveland, Ohio, United States (enrolling)
• Arrow Clinical Trials — Daytona Beach, Florida, United States (enrolling)
• ClinCloud — Maitland, Florida, United States (enrolling)
• Shreenath Clinical Service - Lakewood — Lakewood, California, United States (enrolling)
• University of Alabama - Huntsville Regional Medical Campus — Huntsville, Alabama, United States (enrolling)
• Accellacare - Sherman Oaks — Sherman Oaks, California, United States (enrolling)
• University at Buffalo - UBMD Neurology — Buffalo, New York, United States (enrolling)
• Charter Research - Lady Lake — The Villages, Florida, United States (enrolling)
• Next Level Clinical Trials — West Covina, California, United States (enrolling)
• CenExel iResearch, LLC — Decatur, Georgia, United States (enrolling)
• CenExel iResearch, LLC — Savannah, Georgia, United States (enrolling)
• Neurology Clinic, P.C. — Cordova, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.