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Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease

NCT06808984

RecruitingPhase 2

Sponsor: Celgene

Conditions: Agitation, Alzheimer Disease

Interventions: BMS-986368, Placebo

Countries: United States, Argentina, Australia, China

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.

Eligibility overview

Sex: ALL

Age: 55 Years to 90 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 ≤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.

Locations (75)

Homewood, Alabama, United States
Huntsville, Alabama, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Anaheim, California, United States
Chino, California, United States
La Jolla, California, United States
La Jolla, California, United States
Lakewood, California, United States
Sherman Oaks, California, United States
West Covina, California, United States
West Hills, California, United States
Aurora, Colorado, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Daytona Beach, Florida, United States
Maitland, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
The Villages, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Savannah, Georgia, United States
Honolulu, Hawaii, United States
Elgin, Illinois, United States
Marrero, Louisiana, United States
Foxborough, Massachusetts, United States
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