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RecruitingPhase 2

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

Celgene · NCT06808984

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 55–90 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
120
US sites recruiting
32
Study start
June 9, 2025
Record last updated
October 6, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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.

Being studied: BMS-986368; Placebo

Conditions: Agitation; Alzheimer Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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.

Recruiting US locations

  • University of Alabama - Huntsville Regional Medical Campus

    Huntsville, AL 35801

    Site contact: Tiffany Schwasinger-Schmidt, Site 0036 · 256-551-4512

  • Inland Psychiatric Medical Group.

    Chino, CA 91710

    Site contact: Nandita Puchakayala, Site 0037 · 909-488-9116

  • Kaizen Brain Center

    La Jolla, CA 92037

    Site contact: MOHAMMED AHMED, Site 0018 · 214-893-0542

  • Shreenath Clinical Service - Lakewood

    Lakewood, CA 90805

    Site contact: ERIC TATE, Site 0050 · 714-717-6039

  • Next Level Clinical Trials

    West Covina, CA 91790

    Site contact: Austina Cho, Site 0057 · 714-999-6688

  • University of Colorado Anschutz Medical Campus

    Aurora, CO 80045

    Site contact: Samantha Holden, Site 0066 · 303-724-2046

  • Georgetown University

    Washington D.C., DC 20057

    Site contact: Brigid Reynolds, Site 0067 · 202-687-3350

  • Arrow Clinical Trials

    Daytona Beach, FL 32117

    Site contact: David Billmeier, Site 0003 · 386-278-8000

  • ClinCloud

    Maitland, FL 32751

    Site contact: Rosemary Laird, Site 0013 · 717-357-1569

  • University of South Florida, Department of Psychiatry and Behavioral Neurosciences

    Tampa, FL 33613

    Site contact: Ram Bishnoi, Site 0080 · 813-396-0738

  • Charter Research - Lady Lake

    The Villages, FL 32162

    Site contact: Jeffrey Norton, Site 0039 · 352-775-1000

  • CenExel iResearch, LLC

    Decatur, GA 30030

    Site contact: Kimball Johnson, Site 0035 · 404-537-1281

  • CenExel iResearch, LLC

    Savannah, GA 31405

    Site contact: Yael Elfassy, Site 0015 · 912-744-0800

  • K2 Medical Research

    Foxborough, MA 02035

    Site contact: john stoukides, Site 0025 · 401-435-8950

  • Be Well Clinical Studies - Omaha

    Omaha, NE 68144

    Site contact: John Puente, Site 0062 · 402-937-9293

  • Ocean Medical Research

    Toms River, NJ 08755

    Site contact: Sam Khorrami, Site 0081 · 732-505-5492

  • University at Buffalo - UBMD Neurology

    Buffalo, NY 14203

    Site contact: Kinga Szigeti, Site 0034 · 281-630-2316

  • The Feinstein Institute for Medical Research

    Manhasset, NY 11030

    Site contact: Jeremy Koppel, Site 0049 · 516-562-3492

  • Mid Hudson Medical Research

    New Windsor, NY 12553

    Site contact: Sashi Makam, Site 0044 · 845-674-9398

  • Research Central LLC (DBA Ichor Research)

    Syracuse, NY 13210

    Site contact: Karl Hafner, Site 0021 · 315-529-0766

  • New Hope Clinical Research

    Charlotte, NC 28211

    Site contact: Kurian Abraham, Site 0016 · 980-209-9784

  • UNC Health REX Hospital

    Raleigh, NC 27607

    Site contact: Sandeep Vaishnavi, Site 0063 · 919-784-1092

  • Cleveland Clinic

    Cleveland, OH 44195

    Site contact: Kasia Rothenberg, Site 0023 · 216-403-6847

  • Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience

    Philadelphia, PA 19107

    Site contact: James Ellison, Site 0058 · 215-503-2823

  • Neurology Clinic, P.C.

    Cordova, TN 38018

    Site contact: Thomas Arnold, Site 0019 · 901-866-9252

  • Vanderbilt University Medical Center- Village

    Nashville, TN 37212

    Site contact: Joshua Smith, Site 0033 · 601-594-0792

  • Pinnacle Clinical Research

    Austin, TX 78626

    Site contact: Rohit Puskoor, Site 0060 · 817-602-5188

  • Horizon Clinical Research Center - Houston

    Cypress, TX 77065

    Site contact: Harpaul Gill, Site 0042 · 949-491-0710

  • ANESC Research

    El Paso, TX 79912

    Site contact: Aamr Herekar, Site 0045 · 505-903-1715

  • Stryde Research - Plano

    Plano, TX 75093

    Site contact: Peter Brokish, Site 0065 · 214-407-8640

  • Be Well Clinical Studies

    Round Rock, TX 78681

    Site contact: Mark Carlson, Site 0038 · 000-000-0000

  • Boeson Research - Provo

    Provo, UT 84604

    Site contact: Jason Andersen, Site 0027 · 385-392-2200

Study contacts (from the official record)

  • BMS Clinical Trials Contact Center www.BMSClinicalTrials.com · 855-907-3286 · Clinical.Trials@bms.com
  • First line of the email MUST contain NCT # and Site #.
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