Actively Recruiting

Phase 2
Age: 55Years - 90Years
All Genders
NCT06808984

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

Led by Celgene · Updated on 2026-05-12

120

Participants Needed

53

Research Sites

134 weeks

Total Duration

On this page

AI-Summary

What this Trial 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 55Years - 90Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Alzheimer's disease confirmed by biomarkers, meeting 2024 Revised criteria
  • Agitation diagnosis meeting International Psychogeriatric Association definition
  • History of agitation starting at least four weeks before screening
  • Mini Mental State Examination (MMSE-1) score less than 21
  • Neuropsychiatric Inventory-Nursing Home (NPI-NH) agitation/aggression sub-score of 4 or higher
  • Stable living environment for at least 6 weeks before screening, including nursing homes, assisted living, or home with identified caregiver
  • Able to move independently or with assistive devices such as wheelchairs
Not Eligible

You will not qualify if you...

  • Clinically significant delusions or hallucinations requiring hospitalization
  • History of bipolar disorder, schizophrenia, or schizoaffective disorder
  • History of major depressive episode with psychotic features in the 12 months before screening
  • History of delirium within 30 days before screening
  • Other protocol-defined inclusion/exclusion criteria apply

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 53 locations

1

Local Institution - 0046

Homewood, Alabama, United States, 35209

Not Yet Recruiting

2

University of Alabama - Huntsville Regional Medical Campus

Huntsville, Alabama, United States, 35801

Actively Recruiting

3

NoesisPharma

Phoenix, Arizona, United States, 85016

Actively Recruiting

4

Local Institution - 0040

Scottsdale, Arizona, United States, 85260

Not Yet Recruiting

5

Local Institution - 0017

Anaheim, California, United States, 92805

Not Yet Recruiting

6

Inland Psychiatric Medical Group - Chino

Chino, California, United States, 91710

Actively Recruiting

7

Kaizen Brain Center

La Jolla, California, United States, 92037

Actively Recruiting

8

University of California San Diego - La Jolla

La Jolla, California, United States, 92037

Actively Recruiting

9

Shreenath Clinical Service - Lakewood

Lakewood, California, United States, 90805

Actively Recruiting

10

Accellacare - Sherman Oaks

Sherman Oaks, California, United States, 91403

Actively Recruiting

11

Next Level Clinical Trials

West Covina, California, United States, 91790

Actively Recruiting

12

Alliance Clinical -West Hills

West Hills, California, United States, 91307

Actively Recruiting

13

Local Institution - 0066

Aurora, Colorado, United States, 80045

Not Yet Recruiting

14

Local Institution - 0067

Washington D.C., District of Columbia, United States, 20007

Not Yet Recruiting

15

Local Institution - 0053

Washington D.C., District of Columbia, United States, 20060

Withdrawn

16

Arrow Clinical Trials

Daytona Beach, Florida, United States, 32117

Actively Recruiting

17

ClinCloud

Maitland, Florida, United States, 32751

Actively Recruiting

18

Local Institution - 0007

Maitland, Florida, United States, 32751

Not Yet Recruiting

19

Local Institution - 0022

Miami, Florida, United States, 33125

Withdrawn

20

Local Institution - 0010

Miami, Florida, United States, 33166

Completed

21

Local Institution - 0001

Tampa, Florida, United States, 33607

Not Yet Recruiting

22

Charter Research - Lady Lake

The Villages, Florida, United States, 32162

Actively Recruiting

23

Advanced Discovery Research

Atlanta, Georgia, United States, 30318

Actively Recruiting

24

CenExel iResearch, LLC

Decatur, Georgia, United States, 30030

Actively Recruiting

25

CenExel iResearch, LLC

Savannah, Georgia, United States, 31405

Actively Recruiting

26

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States, 96817

Actively Recruiting

27

Local Institution - 0011

Marrero, Louisiana, United States, 70072

Not Yet Recruiting

28

Local Institution - 0051

South Dartmouth, Massachusetts, United States, 02747

Not Yet Recruiting

29

Boeson Research

Missoula, Montana, United States, 59804

Actively Recruiting

30

Be Well Clinical Studies - Omaha

Omaha, Nebraska, United States, 68144

Actively Recruiting

31

Local Institution - 0041

Las Vegas, Nevada, United States, 89121

Completed

32

Local Institution - 0059

Livingston, New Jersey, United States, 07039

Not Yet Recruiting

33

University at Buffalo - UBMD Neurology

Buffalo, New York, United States, 14203

Actively Recruiting

34

The Feinstein Institute for Medical Research

Manhasset, New York, United States, 11030

Actively Recruiting

35

Mid Hudson Medical Research

New Windsor, New York, United States, 12553

Actively Recruiting

36

Hawthorne Health - Super Health Staten Island

Staten Island, New York, United States, 10309

Actively Recruiting

37

Research Central LLC (DBA Ichor Research)

Syracuse, New York, United States, 13210

Actively Recruiting

38

New Hope Clinical Research

Charlotte, North Carolina, United States, 28211

Actively Recruiting

39

UNC Health REX Hospital

Raleigh, North Carolina, United States, 27607

Actively Recruiting

40

Cleveland Clinic

Cleveland, Ohio, United States, 44195

Actively Recruiting

41

Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience

Philadelphia, Pennsylvania, United States, 19107

Actively Recruiting

42

K2 Medical Research - East Providence

East Providence, Rhode Island, United States, 02914

Actively Recruiting

43

Local Institution - 0031

Chattanooga, Tennessee, United States, 37421

Not Yet Recruiting

44

Neurology Clinic, P.C.

Cordova, Tennessee, United States, 38018

Actively Recruiting

45

Vanderbilt University Medical Center- Village

Nashville, Tennessee, United States, 37212

Actively Recruiting

46

Pinnacle Clinical Research

Austin, Texas, United States, 78626

Actively Recruiting

47

Horizon Clinical Research Center - Houston

Cypress, Texas, United States, 77065

Actively Recruiting

48

ANESC Research

El Paso, Texas, United States, 79912

Actively Recruiting

49

North Pointe Psychiatry - Flower Mound

Flower Mound, Texas, United States, 75028

Actively Recruiting

50

Local Institution - 0020

Houston, Texas, United States, 77030

Withdrawn

51

Stryde Research - Plano

Plano, Texas, United States, 75093

Actively Recruiting

52

Be Well Clinical Studies

Round Rock, Texas, United States, 78681

Actively Recruiting

53

Boeson Research - Provo

Provo, Utah, United States, 84604

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

First line of the email MUST contain NCT # and Site #.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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