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Clinical Trials in the USA / NCT06808984
Recruiting Phase 2

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

NCT06808984 · tracked via the Priya Life Science USA tracker
Sponsor
Celgene
Phase
Phase 2
Started
2025-06-09
Last updated
2026-09-01

Condition(s) studied

AgitationAlzheimer Disease

Investigational drug(s) / intervention(s)

BMS-986368Placebo

BMS-986368: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
55 Years
Max age
90 Years
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 ≤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.

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
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
Local Institution - 0043 Sherman Oaks California Completed
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 Withdrawn
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

+ 38 more sites — see the full list on the official registry below.

More Celgene trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06808984 on ClinicalTrials.gov ↗ ← All trials in the USA