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BMS-986368 for treating agitation in Alzheimer's disease

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)

Phase 2 Interventional Celgene · NCT06808984

This will test whether BMS-986368 can reduce agitation in people with biomarker-confirmed Alzheimer's disease.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment120 (estimated)
Ages55 Years to 90 Years
SexAll
SponsorCelgene Industry-sponsored
Locations53 sites (Homewood, Alabama and 52 other locations)
Trial IDNCT06808984 on ClinicalTrials.gov

What this trial studies

This Phase 2 interventional study compares the FAAH/MAGL inhibitor BMS-986368 to placebo for treating agitation in participants with Alzheimer's disease. Participants must have biomarker-confirmed AD, meet the IPA definition of agitation with symptoms for at least four weeks, an MMSE score below 21, and an NPI-NH agitation/aggression subscore of 4 or higher. The study enrolls people in stable living situations who have an identified caregiver and can travel to study visits, while excluding those with severe psychosis requiring hospitalization or major psychiatric disorders such as bipolar disorder or schizophrenia. Safety, tolerability, and changes in agitation symptoms will be measured over the treatment period using standard clinical scales.

Who should consider this trial

Good fit: Ideal candidates are people with biomarker-confirmed Alzheimer's disease who have IPA-defined agitation for at least four weeks, an MMSE score under 21, and an NPI-NH agitation/aggression subscore ≥4, who live in a stable setting and have a caregiver.

Not a fit: People whose agitation is primarily due to major psychiatric disorders (for example bipolar disorder or schizophrenia), those with severe psychosis requiring hospitalization, or those without biomarker confirmation of AD are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, the drug could meaningfully reduce agitation, improving daily quality of life and potentially reducing use of antipsychotics or restraints.

How similar studies have performed: Targeting the endocannabinoid system with FAAH/MAGL inhibition for AD-related agitation is relatively novel, and prior clinical evidence for similar approaches is limited and mixed.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 \< 21
* 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.

Where this trial is running

Homewood, Alabama and 52 other locations

+3 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions AgitationAlzheimer Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.