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Recruiting Phase 2 Interventional

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

ClinicalTrials.gov ID: NCT06808984

Public ClinicalTrials.gov record NCT06808984. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 3, 2026, 2:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-blind, Three-Arm, Placebo-controlled, Multicenter Study Assessing the Efficacy, Safety and Tolerability of Orally Administered BMS-986368, a FAAH/MAGL Inhibitor, for the Treatment of Agitation in Participants With Alzheimer's Disease (BALANCE-AAD-1)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06808984
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 2
Lead sponsor
Celgene
Industry
Enrollment
120 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
55 Years to 90 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jun 8, 2025
Primary completion
Nov 25, 2027
Completion
Jan 6, 2028
Last update posted
Aug 31, 2026

2025 – 2028

United States locations

U.S. sites
60
U.S. states
24
U.S. cities
55
Facility City State ZIP Site status
Local Institution - 0046 Homewood Alabama 35209 Not yet recruiting
University of Alabama - Huntsville Regional Medical Campus Huntsville Alabama 35801 Recruiting
Local Institution - 0048 Phoenix Arizona 85028 Completed
Local Institution - 0040 Scottsdale Arizona 85260 Not yet recruiting
Local Institution - 0017 Anaheim California 92805 Not yet recruiting
Inland Psychiatric Medical Group. Chino California 91710 Recruiting
Kaizen Brain Center La Jolla California 92037 Recruiting
University of California San Diego - La Jolla La Jolla California 92037 Recruiting
Shreenath Clinical Service - Lakewood Lakewood California 90805 Recruiting
Local Institution - 0043 Sherman Oaks California 91403 Completed
Next Level Clinical Trials West Covina California 91790 Recruiting
Local Institution - 0028 West Hills California 91307 Completed
University of Colorado Anschutz Medical Campus Aurora Colorado 80045 Recruiting
Georgetown University Washington D.C. District of Columbia 20057 Recruiting
Local Institution - 0053 Washington D.C. District of Columbia 20060 Withdrawn
Arrow Clinical Trials Daytona Beach Florida 32117 Recruiting
ClinCloud Maitland Florida 32751 Recruiting
Local Institution - 0007 Maitland Florida 32751 Not yet recruiting
Local Institution - 0022 Miami Florida 33125 Withdrawn
Local Institution - 0010 Miami Florida 33166 Completed
Local Institution - 0001 Tampa Florida 33607 Not yet recruiting
Local Institution - 0080 Tampa Florida 33612 Not yet recruiting
Charter Research - Lady Lake The Villages Florida 32162 Recruiting
Local Institution - 0026 Atlanta Georgia 30318 Completed
CenExel iResearch, LLC Decatur Georgia 30030 Recruiting
CenExel iResearch, LLC Savannah Georgia 31405 Recruiting
Local Institution - 0004 Honolulu Hawaii 96817 Completed
Local Institution - 0086 Elgin Illinois 60123 Withdrawn
Local Institution - 0011 Marrero Louisiana 70072 Not yet recruiting
K2 Medical Research Foxborough Massachusetts 02035 Recruiting
Local Institution - 0051 South Dartmouth Massachusetts 02747 Not yet recruiting
Local Institution - 0088 Sterling Heights Michigan 48312 Not yet recruiting
Boeson Research Missoula Montana 59804 Recruiting
Be Well Clinical Studies - Omaha Omaha Nebraska 68144 Recruiting
Local Institution - 0041 Las Vegas Nevada 89121 Completed
Local Institution - 0059 Livingston New Jersey 07039 Not yet recruiting
Local Institution - 0081 Toms River New Jersey 08755 Not yet recruiting
University at Buffalo - UBMD Neurology Buffalo New York 14203 Recruiting
The Feinstein Institute for Medical Research Manhasset New York 11030 Recruiting
Mid Hudson Medical Research New Windsor New York 12553 Recruiting
Local Institution - 0064 Staten Island New York 10309 Completed
Research Central LLC (DBA Ichor Research) Syracuse New York 13210 Recruiting
New Hope Clinical Research Charlotte North Carolina 28211 Recruiting
UNC Health REX Hospital Raleigh North Carolina 27607 Recruiting
Cleveland Clinic Cleveland Ohio 44195 Recruiting
Local Institution - 0087 Columbus Ohio 43221 Not yet recruiting
Local Institution - 0089 Ardmore Oklahoma 73401 Not yet recruiting
Thomas Jefferson University - Vickie & Jack Farber Institute for Neuroscience Philadelphia Pennsylvania 19107 Recruiting
Local Institution - 0031 Chattanooga Tennessee 37421 Not yet recruiting
Neurology Clinic, P.C. Cordova Tennessee 38018 Recruiting
Vanderbilt University Medical Center- Village Nashville Tennessee 37212 Recruiting
Pinnacle Clinical Research Austin Texas 78626 Recruiting
Horizon Clinical Research Center - Houston Cypress Texas 77065 Recruiting
ANESC Research El Paso Texas 79912 Recruiting
Local Institution - 0024 Flower Mound Texas 75028 Completed
Local Institution - 0020 Houston Texas 77030 Withdrawn
Stryde Research - Plano Plano Texas 75093 Recruiting
Local Institution - 0091 Richardson Texas 75082 Not yet recruiting
Be Well Clinical Studies Round Rock Texas 78681 Recruiting
Boeson Research - Provo Provo Utah 84604 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 18 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06808984, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 31, 2026 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06808984 live on ClinicalTrials.gov.

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