Recruiting

BMS-986368 for Agitation in Alzheimer's Disease

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What is being tested

BMS-986368

+ Placebo

Drug
Who is being recruted

Aberrant Motor Behavior in Dementia+16

+ Alzheimer Disease

+ Behavior

From 55 to 90 Years
+12 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: June 2025
See protocol details

Summary

Principal SponsorCelgene
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: June 9, 2025

Actual date on which the first participant was enrolled.

This study focuses on evaluating a new treatment for managing agitation in people with Alzheimer's Disease. Agitation is a common and challenging symptom in Alzheimer's patients that can significantly affect their quality of life and the well-being of their caregivers. The study is testing a drug called BMS-986368, which is taken orally and acts as a FAAH/MAGL inhibitor. The goal is to determine if this treatment can effectively and safely reduce agitation in affected individuals, potentially offering a new option for improving care in this population. Participants in this study will receive the treatment in one of three ways: the active drug, a placebo, or another comparator, all administered in a blinded manner, meaning neither doctors nor participants know which one is being given. The study takes place across multiple centers, ensuring a wide range of data. Researchers will closely monitor participants to assess the treatment's effectiveness, safety, and how well individuals tolerate it. This approach helps gather comprehensive information on how the drug performs and its potential side effects, which is crucial for developing effective treatments.

Official TitleA 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)
NCT06808984
Principal SponsorCelgene
Study ContactBMS Clinical Trials Contact Center www.BMSClinicalTrials.comMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 55 to 90 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Aberrant Motor Behavior in DementiaAlzheimer DiseaseBehaviorMental DisordersBehavioral SymptomsBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurologic ManifestationsPsychomotor AgitationPsychomotor DisordersSigns and SymptomsPathological Conditions, Signs and SymptomsNeurodegenerative DiseasesNeurobehavioral ManifestationsNeurocognitive DisordersDyskinesiasTauopathies

Criteria

7 inclusion criteria required to participate
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
NPI-NH agitation/aggression sub-score ≥ 4.
Show More Criteria
5 exclusion criteria prevent from participating
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.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental

Group II

Experimental

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 52 locations

Recruiting

University of Alabama - Huntsville Regional Medical Campus

Huntsville, United StatesOpen University of Alabama - Huntsville Regional Medical Campus in Google Maps
Recruiting

NoesisPharma

Phoenix, United States
Recruiting

Inland Psychiatric Medical Group, Inc

Chino, United States
Recruiting

Kaizen Brain Center

La Jolla, United States
Recruiting
52 Study Centers