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Recruiting

Study to Evaluate the Efficacy, Safety, and Tolerability of an Anti-MTBR Tau Monoclonal Antibody (BMS-986446) in Participants With Early Alzheimer's Disease - CN008-0003

Aktualisiert: 26 April, 2024   |   ClinicalTrials.gov

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Studiendetails

  • Phase 2

    Phase

  • Geschlecht(er)

  • 50-80

    Altersgruppe

  • 148

    Standort(e)

  • Recruiting

Behandlungsmöglichkeiten

Studienarme
ZUGEWIESENE BEHANDLUNG
Experimental: BMS-986446 Dose A
Drug: BMS-986446
Experimental: BMS-986446 Dose B
Drug: BMS-986446
Placebo Comparator: Placebo
Other: Placebo

Wichtigste Eignungskriterien

Inclusion Criteria - 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. - 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. - Evidence of AD pathology. - 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). - Mini Mental Status Examination (MMSE) score ≥ 22 to 30 (inclusive). Exclusion Criteria - Any evidence of a condition that may affect cognition other than AD. - Contraindications to PET imaging. - Inability to tolerate or contraindication to magnetic resonance imaging. - Any serious medical condition that could, in the opinion of the investigator, affect the participant's safety or interfere with study assessments. - Geriatric Depression Scale (GDS) score greater than or equal to 8 at screening. - Other protocol-defined Inclusion/Exclusion criteria apply.

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