NCT06808984 · Phase 2 · RECRUITING
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
This trial tests BMS-986368, an experimental drug that works on the body's endocannabinoid system, to see whether it reduces agitation in people who already have Alzheimer's disease. Agitation — restlessness, aggression, emotional outbursts — is one of the hardest symptoms for caregivers to manage. This is a Phase 2 trial, meaning researchers are still gathering early evidence on whether it works and is safe. It is not proven or approved.
You may qualify if
- 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.
You're excluded if
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-05-12