Agitation study: BMS-986368
Official title 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
What this study is testing
What is BMS-986368?
An investigational oral medication being studied for the treatment of agitation in people with Alzheimer’s disease. It is designed to inhibit FAAH and MAGL enzymes to modulate endocannabinoid signaling.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study will see if BMS‑986368 helps calm agitation and if it is safe and well tolerated.
- Who it's for
- Adults with Alzheimer’s disease who experience agitation.
- What's involved
- Participants will receive the drug and have regular visits for health checks and tests.
- Time commitment
- The study lasts several months and requires multiple clinic visits for monitoring.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90
You may be able to join if
- Participants with a diagnosis of Alzheimer's disease with biomarker confirmation meeting the 2024 Revised criteria for diagnosis and staging of AD...
- 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.
You likely can't join 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.
See the full eligibility 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.
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Huntsville, Alabama, United States
- Chino, California, United States
- La Jolla, California, United States
- Lakewood, California, United States
- West Covina, California, United States
- Aurora, Colorado, United States
- Washington D.C., District of Columbia, United States
- Daytona Beach, Florida, United States
- Maitland, Florida, United States
- Tampa, Florida, United States
- The Villages, Florida, United States
- Decatur, Georgia, United States
- Savannah, Georgia, United States
- Foxborough, Massachusetts, United States
- Omaha, Nebraska, United States
- Toms River, New Jersey, United States
- Buffalo, New York, United States
- Manhasset, New York, United States
- New Windsor, New York, United States
- Syracuse, New York, United States
+ 12 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 90 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Huntsville, Alabama, United States; Chino, California, United States; La Jolla, California, United States; Lakewood, California, United States; West Covina, California, United States; Aurora, Colorado, United States and 26 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.