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โ† Trials
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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

RecruitingPhase 2Ages 55 Years - 90 YearsAllCelgene
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ค24. * NPI-NH agitation/aggression sub-score โ‰ฅ 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.
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What it tests

  • BMS-986368
  • Placebo
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Where

77 sites
Local Institution - 0046
Homewood, United States
University of Alabama - Huntsville Regional Medical Campus
Huntsville, United States
Local Institution - 0048
Phoenix, United States
Local Institution - 0040
Scottsdale, United States
Local Institution - 0017
Anaheim, United States
Inland Psychiatric Medical Group.
Chino, United States
Kaizen Brain Center
La Jolla, United States
Local Institution - 0052
La Jolla, United States

โ€ฆand 69 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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