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
Updated:
25 November, 2024
|
ClinicalTrials.gov
Phase
Gender(s)
Age Range
Location(s)
Recruiting
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.
If you want to report a side effect, you can report directly to the Danish Medicines Agency via the website www.meldenbivirkning.dk
We recommend that you also contact BMS to report side effects.
Side effects and other reportable events are defined here
Report side effects or product quality complaints: Medical Information
466-DK-2200001