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Clinical trial · NCT06808984

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

RecruitingPhase 2

Sponsor: Celgene

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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.

Interventions

  • BMS-986368 · DRUG

    Specified dose on specified days

  • Placebo · DRUG

    Specified dose on specified days

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.

Sites (78)

  • Local Institution - 0046, Homewood, Alabama · Not yet recruiting
  • University of Alabama - Huntsville Regional Medical Campus, Huntsville, Alabama · Recruiting
  • Local Institution - 0048, Phoenix, Arizona · Completed
  • Local Institution - 0040, Scottsdale, Arizona · Not yet recruiting
  • Local Institution - 0017, Anaheim, California · Not yet recruiting
  • Inland Psychiatric Medical Group., Chino, California · Recruiting
  • Kaizen Brain Center, La Jolla, California · Recruiting
  • University of California San Diego - La Jolla, La Jolla, California · Recruiting
  • Shreenath Clinical Service - Lakewood, Lakewood, California · Recruiting
  • Local Institution - 0043, Sherman Oaks, California · Completed
  • Next Level Clinical Trials, West Covina, California · Recruiting
  • Local Institution - 0028, West Hills, California · Completed
  • University of Colorado Anschutz Medical Campus, Aurora, Colorado · Recruiting
  • Georgetown University, Washington D.C., District of Columbia · Recruiting
  • Local Institution - 0053, Washington D.C., District of Columbia · Withdrawn
  • Arrow Clinical Trials, Daytona Beach, Florida · Recruiting
  • ClinCloud, Maitland, Florida · Recruiting
  • Local Institution - 0007, Maitland, Florida · Not yet recruiting
  • Local Institution - 0022, Miami, Florida · Withdrawn
  • Local Institution - 0010, Miami, Florida · Completed
  • Local Institution - 0001, Tampa, Florida · Not yet recruiting
  • Local Institution - 0080, Tampa, Florida · Not yet recruiting
  • Charter Research - Lady Lake, The Villages, Florida · Recruiting
  • Local Institution - 0026, Atlanta, Georgia · Completed
  • CenExel iResearch, LLC, Decatur, Georgia · Recruiting
  • CenExel iResearch, LLC, Savannah, Georgia · Recruiting
  • Local Institution - 0004, Honolulu, Hawaii · Completed
  • Local Institution - 0086, Elgin, Illinois · Withdrawn
  • Local Institution - 0011, Marrero, Louisiana · Not yet recruiting
  • K2 Medical Research, Foxborough, Massachusetts · Recruiting
  • Local Institution - 0051, South Dartmouth, Massachusetts · Not yet recruiting
  • Local Institution - 0088, Sterling Heights, Michigan · Not yet recruiting
  • Boeson Research, Missoula, Montana · Recruiting
  • Be Well Clinical Studies - Omaha, Omaha, Nebraska · Recruiting
  • Local Institution - 0041, Las Vegas, Nevada · Completed
  • Local Institution - 0059, Livingston, New Jersey · Not yet recruiting
  • Local Institution - 0081, Toms River, New Jersey · Not yet recruiting
  • University at Buffalo - UBMD Neurology, Buffalo, New York · Recruiting
  • The Feinstein Institute for Medical Research, Manhasset, New York · Recruiting
  • Mid Hudson Medical Research, New Windsor, New York · Recruiting
  • Local Institution - 0064, Staten Island, New York · Completed
  • Research Central LLC (DBA Ichor Research), Syracuse, New York · Recruiting
  • New Hope Clinical Research, Charlotte, North Carolina · Recruiting
  • UNC Health REX Hospital, Raleigh, North Carolina · Recruiting
  • Cleveland Clinic, Cleveland, Ohio · Recruiting
  • Local Institution - 0087, Columbus, Ohio · Not yet recruiting
  • Local Institution - 0089, Ardmore, Oklahoma · Not yet recruiting
  • Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience, Philadelphia, Pennsylvania · Recruiting
  • Local Institution - 0031, Chattanooga, Tennessee · Not yet recruiting
  • Neurology Clinic, P.C., Cordova, Tennessee · Recruiting
  • Vanderbilt University Medical Center- Village, Nashville, Tennessee · Recruiting
  • Pinnacle Clinical Research, Austin, Texas · Recruiting
  • Horizon Clinical Research Center - Houston, Cypress, Texas · Recruiting
  • ANESC Research, El Paso, Texas · Recruiting
  • Local Institution - 0024, Flower Mound, Texas · Completed
  • Local Institution - 0020, Houston, Texas · Withdrawn
  • Stryde Research - Plano, Plano, Texas · Recruiting
  • Local Institution - 0091, Richardson, Texas · Not yet recruiting
  • Be Well Clinical Studies, Round Rock, Texas · Recruiting
  • Boeson Research - Provo, Provo, Utah · Recruiting
  • Local Institution - 0068, Ciudad Autónoma de Buenos Aires, Buenos Aires · Not yet recruiting
  • Local Institution - 0071, Mar del Plata, Buenos Aires · Not yet recruiting
  • Local Institution - 0074, Córdoba, Córdoba Province · Not yet recruiting
  • Local Institution - 0069, Buenos Aires, Argentina · Not yet recruiting
  • Local Institution - 0075, Córdoba, Argentina · Not yet recruiting
  • Local Institution - 0072, Mendoza, Argentina · Not yet recruiting
  • Local Institution - 0073, Santiago del Estero, Argentina · Not yet recruiting
  • Local Institution - 0076, Macquarie Park, New South Wales · Not yet recruiting
  • Local Institution - 0090, Daw Park, South Australia · Not yet recruiting
  • Local Institution - 0079, Wangaratta, Victoria · Not yet recruiting
  • Local Institution - 0078, Nedlands, Western Australia · Not yet recruiting
  • Local Institution - 0077, Darlinghurst, Australia · Not yet recruiting
  • Local Institution - 0084, Hefei, Anhui · Not yet recruiting
  • Local Institution - 0092, Beijing, Beijing Municipality · Not yet recruiting
  • Local Institution - 0093, Wuhan, HUB · Not yet recruiting
  • Local Institution - 0085, Nanjing, Jiangsu · Not yet recruiting
  • Local Institution - 0082, Shanghai Shi, Shanghai Municipality · Not yet recruiting
  • Local Institution - 0083, Hangzhou, Zhejiang · Not yet recruiting

Not medical advice. Trial0 is a navigation service, not a medical provider. Nothing here is medical advice or a recommendation to pursue any treatment; eligibility matching is informational, based on published registry criteria, and only the trial site or treating clinician can determine actual eligibility. Decisions belong with the patient and their own doctors. Registry data refreshed at most hourly; last update posted 2026-09-01.