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NCT06808984
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
Conditions: Agitation, Alzheimer Disease
Sex: All
Ages: 55 Years – 90 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 120
Sponsor: Celgene
Location: Local Institution - 0046 Homewood Alabama
Summary
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 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.
Source: ClinicalTrials.gov (NCT06808984). StuddyBuddy aggregates publicly available trial information.