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

Celgene

Status and phase: Enrolling; Phase 2

Conditions: Alzheimer Disease; Agitation

Treatments: Drug: Placebo; Drug: BMS-986368

Study type: Interventional

Funder types: Industry

Identifiers

NCT06808984

IM045-P06

U1111-1313-8997 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 55 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 3 patient groups, including a placebo group

BMS-986368 Dose 1

Experimental group

Treatment:

Drug: BMS-986368

BMS-986368 Dose 2

Experimental group

Treatment:

Drug: BMS-986368

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo