Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
Purpose
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
Conditions
- Agitation
- Alzheimer Disease
Eligibility
- Eligible Ages
- Between 55 Years and 90 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental BMS-986368 Dose 1 |
|
|
|
Experimental BMS-986368 Dose 2 |
|
|
|
Placebo Comparator Placebo |
|
Recruiting Locations
Vanderbilt University Medical Center- Village
Nashville 4644585, Tennessee 4662168 37212
Nashville 4644585, Tennessee 4662168 37212
Contact:
Joshua Smith, Site 0033
601-594-0792
Joshua Smith, Site 0033
601-594-0792
More Details
- Status
- Recruiting
- Sponsor
- Celgene
Study Contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com8559073286
Clinical.Trials@bms.com