Actively Recruiting
A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled Study Evaluating Oral BMS-986368, a FAAH/MAGL Inhibitor, for Agitation in Alzheimer's Disease
Led by Celgene · Updated on 2026-06-02
120
Participants Needed
53
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating BMS-986368, a FAAH/MAGL inhibitor, for treating agitation in people with Alzheimer's Disease. This Phase 2 study aims to assess the drug's effectiveness, safety, and tolerability in this population. Participants must have confirmed Alzheimer's disease with biomarkers and meet specific agitation criteria based on established clinical definitions. Participants will be randomly assigned to receive one of two doses of BMS-986368 or a placebo. The study is double-blind and will take place across multiple centers. The treatment is given orally on specified days, and the study includes a placebo control for comparison. The trial is designed to last up to 8 weeks for primary assessments, with additional monitoring for safety and drug levels extending up to 14 weeks. Participants will undergo various assessments including the Cohen-Mansfield Agitation Inventory (CMAI) to measure agitation changes, Clinical Global Impression-Severity (CGI-S), and Neuropsychiatric Inventory Nursing Home Version (NPI-NH) scores. Safety evaluations include monitoring adverse events and laboratory tests. The study also tracks potential withdrawal symptoms and drug plasma concentrations. Total participation may last up to 14 weeks, including follow-up after the last dose.
CONDITIONS
Brief 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
Eligibility Criteria
You may qualify if you...
- Diagnosis of Alzheimer's disease confirmed by biomarker tests meeting 2024 Revised criteria
- Diagnosis of agitation meeting International Psychogeriatric Association definition
- History of agitation for at least 4 weeks before screening
- Mini-Mental State Examination (MMSE-1) score of 24 or less
- 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 caregiver
- Able to move independently or with assistive device such as wheelchair
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 within 12 months before screening
- History of delirium within 30 days before screening
- Other protocol-defined inclusion or exclusion criteria may apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 8 weeks
Participants receive oral doses of BMS-986368 or placebo to evaluate efficacy, safety, and tolerability for agitation in Alzheimer's disease.
Weekly visits for up to 8 weeks
Duration - Up to 6 weeks after treatment ends
Participants are monitored for adverse events, withdrawal symptoms, and plasma concentrations after the last dose.
Visits up to 28 days after last dose and additional visits up to 14 weeks from baseline
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
Local Institution - 0048
Phoenix, Arizona, United States, 85028
Completed
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, 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
Local Institution - 0028
West Hills, California, United States, 91307
Completed
13
University of Colorado Anschutz Medical Campus
Aurora, Colorado, United States, 80045
Actively 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
Local Institution - 0026
Atlanta, Georgia, United States, 30318
Completed
24
CenExel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
25
CenExel iResearch, LLC
Savannah, Georgia, United States, 31405
Actively Recruiting
26
Local Institution - 0004
Honolulu, Hawaii, United States, 96817
Completed
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
Local Institution - 0064
Staten Island, New York, United States, 10309
Completed
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
Research Team
B
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
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First line of the email MUST contain NCT # and Site #.
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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