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

Launched by CELGENE · Jan 30, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at a new medication called BMS-986368, which aims to help reduce agitation in people with Alzheimer's disease. Agitation can include feelings of restlessness, irritability, or anxiety, and this study will help determine how effective and safe the medication is for treating these symptoms. The trial is currently not recruiting participants, but it will include adults who have been diagnosed with Alzheimer's disease and have experienced agitation for at least four weeks.

To be eligible for this study, participants should have a confirmed diagnosis of Alzheimer's disease, show some level of agitation, and have a stable living situation, whether at home or in a care facility. They also need to be able to move around, even with assistance. Participants will have their health monitored throughout the trial, and they will be supported by a study partner, typically a caregiver. If you or someone you know meets these criteria and is interested in participating, it's important to keep an eye out for when the study begins recruiting!

Gender

ALL

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 \< 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.