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Trial ID CN008-0003  |   NCT06268886

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease

Summary

  • Phase 2
  • Male and Female Gender icon
  • 60-80
    Age Range
  • 165
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this study is to assess the effectiveness, safety, and tolerability of BMS-986446 an Anti-MTBR Tau Monoclonal Antibody in participants with Early Alzheimer's Disease.

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Key Eligibility Criteria

Inclusion Criteria

Inclusion Criteria Icon img
  • Mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild AD dementia consistent with the National Institute on Aging and the Alzheimer's Association (NIA-AA) core clinical criteria.
    1. Global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and a CDR-Memory Box score of 0.5 and greater at screening and Baseline.
      1. Evidence of AD pathology.
        1. Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory Subtest II (WMS-IV LM II).
          1. Mini Mental Status Examination (MMSE) score ≥ 20 to 28 (inclusive).

            Exclusion Criteria

            Exclusion Criteria Icon
            • Any evidence of a condition that may affect cognition other than AD.
              1. Contraindications to PET imaging.
                1. Inability to tolerate or contraindication to magnetic resonance imaging.
                  1. Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments.
                    1. Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening.
                      Additional Information *
                      • Other protocol-defined Inclusion/Exclusion criteria apply.

                        Treatment Options

                        Study Arms

                        ASSIGNED INTERVENTION

                        Study Arms

                        Experimental: BMS-986446 Dose A

                        ASSIGNED INTERVENTION
                        • Drug: BMS-986446

                        Study Arms

                        Experimental: BMS-986446 Dose B

                        ASSIGNED INTERVENTION
                        • Drug: BMS-986446

                        Study Arms

                        Placebo Comparator: Placebo

                        ASSIGNED INTERVENTION
                        • Other: Placebo
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