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Trial ID IM045-P06  |   NCT06808984

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

Celgene Corporation, a wholly owned subsidiary of Bristol-Myers Squibb Company

Summary

  • Phase 2
  • Male and Female Gender icon
  • 55-90
    Age Range
  • 60
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

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.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • 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.
    1. The diagnosis of agitation must meet the International Psychogeriatric Association (IPA) definition of agitation.
      1. History of agitation with onset at least four weeks prior to Screening.
        1. MMSE-1 score ≤24.
          1. NPI-NH agitation/aggression sub-score ≥ 4.
            1. 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).
              1. Capable of self-locomotion (alone or with the aid of an assistive device); wheelchairs and other mobility aids are acceptable.

                Exclusion Criteria

                Exclusion Criteria Icon
                • Clinically significant delusions/hallucinations requiring hospitalization.
                  1. History of bipolar disorder, schizophrenia, or schizoaffective disorder.
                    1. History of major depressive episode with psychotic features during the 12 months prior to Screening.
                      1. History of delirium within 30 days of Screening.
                        Additional Information *
                        • Other protocol-defined Inclusion/Exclusion criteria apply.

                          Treatment Options

                          Study Arms

                          ASSIGNED INTERVENTION

                          Study Arms

                          Experimental: BMS-986368 Dose 1

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986368

                          Study Arms

                          Experimental: BMS-986368 Dose 2

                          ASSIGNED INTERVENTION
                          • Drug: BMS-986368

                          Study Arms

                          Placebo Comparator: Placebo

                          ASSIGNED INTERVENTION
                          • Drug: Placebo
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