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Clinical trial · NCT06808984 · RECRUITING · PHASE2

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

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 (75)

  • 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
  • Accellacare - Sherman Oaks, Sherman Oaks, California · RECRUITING
  • 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 · NOT_YET_RECRUITING
  • 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 - 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, Argentina · NOT_YET_RECRUITING
  • Local Institution - 0071, Mar del Plata, Buenos Aires, Argentina · NOT_YET_RECRUITING
  • Local Institution - 0074, Córdoba, Córdoba Province, Argentina · 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, Australia · NOT_YET_RECRUITING
  • Local Institution - 0090, Daw Park, South Australia, Australia · NOT_YET_RECRUITING
  • Local Institution - 0079, Wangaratta, Victoria, Australia · NOT_YET_RECRUITING
  • Local Institution - 0078, Nedlands, Western Australia, Australia · NOT_YET_RECRUITING
  • Local Institution - 0077, Darlinghurst, Australia · NOT_YET_RECRUITING
  • Local Institution - 0084, Hefei, Anhui, China · NOT_YET_RECRUITING
  • Local Institution - 0085, Nanjing, Jiangsu, China · NOT_YET_RECRUITING
  • Local Institution - 0082, Shanghai Shi, Shanghai Municipality, China · NOT_YET_RECRUITING
  • Local Institution - 0083, Hangzhou, Zhejiang, China · 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 2026-08-13.