Last updated 5 days ago
Study to Evaluate the Efficacy, Safety, and Tolerability of BMS-986368, for the Treatment of Agitation in Participants With Alzheimer's Disease
120 patients around the world
Available in Argentina, United States
Celgene
120Patients around the world
This study is for people with
Alzheimer disease
Requirements for the patient
To 90 Years
All Gender
Medical requirements
- 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.
- 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.
SponsorCelgene
Study typeInterventional
Conditions
Alzheimer disease
Requirements
To 90 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06808984
