BMS-986368 for treating agitation in Alzheimer's disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• University of Alabama - Huntsville Regional Medical Campus
  Huntsville, Alabama, United States Recruiting
• Inland Psychiatric Medical Group.
  Chino, California, United States Recruiting
• Kaizen Brain Center
  La Jolla, California, United States Recruiting
• Shreenath Clinical Service - Lakewood
  Lakewood, California, United States Recruiting
• Next Level Clinical Trials
  West Covina, California, United States Recruiting
• University of Colorado Anschutz Medical Campus
  Aurora, Colorado, United States Recruiting

+27 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.