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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 55 Years and 90 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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 < 21 - 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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
BMS-986368 Dose 1
  • Drug: BMS-986368
    Specified dose on specified days
    Other names:
    • CC-97489
Experimental
BMS-986368 Dose 2
  • Drug: BMS-986368
    Specified dose on specified days
    Other names:
    • CC-97489
Placebo Comparator
Placebo
  • Drug: Placebo
    Specified dose on specified days

Recruiting Locations

University of Alabama - Huntsville Regional Medical Campus
Huntsville, Alabama 35801
Contact:
Tiffany Schwasinger-Schmidt, Site 0036
256-551-4512

NoesisPharma
Phoenix, Arizona 85016
Contact:
Lee Kelley, Site 0048
602-795-1834

Inland Psychiatric Medical Group - Chino
Chino, California 91710
Contact:
Nandita Puchakayala, Site 0037
909-488-9116

Kaizen Brain Center
La Jolla, California 92037
Contact:
MOHAMMED AHMED, Site 0018
214-893-0542

University of California San Diego - La Jolla
La Jolla, California 92037
Contact:
Gabriel Leger, Site 0052
714-415-8982

Shreenath Clinical Service - Lakewood
Lakewood, California 90805
Contact:
ERIC TATE, Site 0050
714-717-6039

Accellacare - Sherman Oaks
Sherman Oaks, California 91403
Contact:
Neeraj Gupta, Site 0043
562-548-8500

Next Level Clinical Trials
West Covina, California 91790
Contact:
Austina Cho, Site 0057
714-999-6688

Alliance Clinical -West Hills
West Hills, California 91307
Contact:
Leon Barkodar, Site 0028
818-257-3140

Arrow Clinical Trials
Daytona Beach, Florida 32117
Contact:
David Billmeier, Site 0003
386-278-8000

ClinCloud
Maitland, Florida 32751
Contact:
Rosemary Laird, Site 0013
717-357-1569

Ocean Blue Medical Research Center
Miami, Florida 33166
Contact:
Antonio Terrelonge, Site 0010
305-885-8983

Charter Research - Lady Lake
The Villages, Florida 32162
Contact:
Jeffrey Norton, Site 0039
352-775-1000

Advanced Discovery Research
Atlanta, Georgia 30318
Contact:
David Purselle, Site 0026
470-777-8839

CenExel iResearch, LLC
Decatur, Georgia 30030
Contact:
Kimball Johnson, Site 0035
404-537-1281

CenExel iResearch, LLC
Savannah, Georgia 31405
Contact:
Yael Elfassy, Site 0015
912-744-0800

Hawaii Pacific Neuroscience
Honolulu, Hawaii 96817
Contact:
Kore Liow, Site 0004
808-564-6142

Be Well Clinical Studies - Omaha
Omaha, Nebraska 68144
Contact:
John Puente, Site 0062
402-937-9293

Oasis Clinical Trials
Las Vegas, Nevada 89121
Contact:
Zinoviy Benzar, Site 0041
702-832-1369

University at Buffalo - UBMD Neurology
Buffalo, New York 14203
Contact:
Kinga Szigeti, Site 0034
281-630-2316

The Feinstein Institute for Medical Research
Manhasset, New York 11030
Contact:
Jeremy Koppel, Site 0049
516-562-3492

Mid Hudson Medical Research
New Windsor, New York 12553
Contact:
Sashi Makam, Site 0044
845-674-9398

Hawthorne Health - Super Health Staten Island
Staten Island, New York 10309
Contact:
Risa Ravitz, Site 0064
415-343-2600

Research Central LLC (DBA Ichor Research)
Syracuse, New York 13210
Contact:
Karl Hafner, Site 0021
315-529-0766

New Hope Clinical Research
Charlotte, North Carolina 28211
Contact:
Kurian Abraham, Site 0016
980-209-9784

UNC Health REX Hospital
Raleigh, North Carolina 27607
Contact:
Sandeep Vaishnavi, Site 0063
919-784-1198

Cleveland Clinic
Cleveland, Ohio 44195
Contact:
Kasia Rothenberg, Site 0023
216-403-6847

Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience
Philadelphia, Pennsylvania 19107
Contact:
James Ellison, Site 0058
215-503-2823

K2 Medical Research - East Providence
East Providence, Rhode Island 02914
Contact:
john stoukides, Site 0025
401-435-8950

Neurology Clinic, P.C.
Cordova, Tennessee 38018
Contact:
Thomas Arnold, Site 0019
901-866-9252

Vanderbilt University Medical Center- Village
Nashville, Tennessee 37212
Contact:
Joshua Smith, Site 0033
601-594-0792

Pinnacle Clinical Research
Austin, Texas 78626
Contact:
Rohit Puskoor, Site 0060
817-602-5188

Horizon Clinical Research Center - Houston
Cypress, Texas 77065
Contact:
Harpaul Gill, Site 0042
949-491-0710

ANESC Research
El Paso, Texas 79912
Contact:
Aamr Herekar, Site 0045
505-903-1715

North Pointe Psychiatry - Flower Mound
Flower Mound, Texas 75028
Contact:
Asad Islam, Site 0024
469-444-2244

Stryde Research - Plano
Plano, Texas 75093
Contact:
Peter Brokish, Site 0065
214-407-8640

Be Well Clinical Studies
Round Rock, Texas 78681
Contact:
Mark Carlson, Site 0038
000-000-0000

Boeson Research - Provo
Provo, Utah 84604
Contact:
Jason Andersen, Site 0027
385-392-2200

More Details

NCT ID
NCT06808984
Status
Recruiting
Sponsor
Celgene

Study Contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
855-907-3286
Clinical.Trials@bms.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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