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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

Aggiornato: 23 maggio, 2024   |   ClinicalTrials.gov.

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STA PRENDENDO IN CONSIDERAZIONE QUESTA SPERIMENTAZIONE?
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Dettagli della sperimentazione

  • Phase 2

    Fase

  • Sesso

  • 50-80

    Fascia d'età

  • 150

    Sede/i

  • Recruiting

Opzioni di trattamento

Bracci dello studio
INTERVENTO ASSEGNATO
Experimental: BMS-986446 Dose A
Drug: BMS-986446
Experimental: BMS-986446 Dose B
Drug: BMS-986446
Placebo Comparator: Placebo
Other: Placebo

Principali criteri di idoneità

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.

Ti consigliamo vivamente di contattare BMS per segnalare gli effetti collaterali (eventi avversi)
Qui vengono definiti gli effetti collaterali (eventi avversi) e altri eventi da segnalare
Segnala effetti collaterali (eventi avversi) o reclami sulla qualità del prodotto: informazioni mediche