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Active (not recruiting) Phase 2 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

Phase 2 – studying effectiveness and dosage
Conditions: Alzheimer Disease, Early Onset

Sponsor: Bristol-Myers Squibb

trial.available_in: БГ
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.
Who can participate
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 ≥ 20 to 28 (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.
Locations 10
Australia (1)
Local Institution - 0111
East Gosford , New South Wales
Belgium (1)
Local Institution - 0122
Anderlecht , Brussels Capital
Canada (1)
Local Institution - 0112
Ottawa , Ontario
Japan (1)
Local Institution - 0181
Nagoya , Aichi-ken
Singapore (1)
Local Institution - 0091
Singapore
South Korea (1)
Local Institution - 0117
Songpa-gu , Seoul
Spain (1)
Local Institution - 0158
Barcelona , B
Sweden (1)
Local Institution - 0167
Malmo , M
United Kingdom (1)
Local Institution - 0121
Enfield , LND
United States (1)
Local Institution - 0068
Chandler , Arizona
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
50 Years
Maximum age
80 Years
Healthy volunteers
No
Start date
20.03.2024
Completion date
18.03.2027
Registry ID
NCT06268886
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.