Anti-tau antibody therapy (BMS-986446) for early Alzheimer's disease.
- Study HIC#:2000037714
- Last Updated:03/04/2025
BMS-986446 for Early Alzheimer’s Disease. BMS-986446 is a monoclonal antibody directed against extracellular tau protein, thereby slowing the toxic spread of this protein in Alzheimer’s disease. This phase 2 study will evaluate the safety, tolerability, and efficacy of BMS-986446 in participants ages 50-80 years with early Alzheimer’s disease for 76 weeks. Participants will be randomly assigned in a 4:3:3 ratio to receive either 1400 mg or 4200 mg of BMS-986446 or placebo (60% probability of receiving active BMS-986446). Infusions will occur every 4 weeks. All participants will receive 5 MRI scans and will also undergo 3 tau PET scans. Participants who complete the double-blind treatment phase may be eligible to enter a 96-week open-label extension study in which all subjects will receive BMS-986446. Permits concurrent treatment with cholinesterase inhibitors and/or memantine, providing they have been on a stable dose for at least 12 weeks prior to baseline. HIC# 2000037714.
- Age60 years - 80 years
- GenderBoth
Contact Us
For more information about this study, including how to volunteer, contact:
ADRU Main Office
- Phone Number: 1-203-764-8100
Help Us Discover!
You can help our team find trials you might be eligible for by creating a volunteer profile in MyChart. To get started, create a volunteer profile, or contact helpusdiscover@yale.edu, or call +18779788343 for more information.
Eligibility Criteria
- 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.
