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

Alzheimer Disease, Early Onset

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.

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Participation Requirements

  • Sex:

    ALL
  • Eligible Ages:

    60 to 80

Participation 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.
* Other protocol-defined Inclusion/Exclusion criteria apply.

Study Location

The Rotman Research Institute at Baycrest
The Rotman Research Institute at Baycrest
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Howard Chertkow, Site 0109

41678525003078
Local Institution - 0075
Local Institution - 0075
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Site 0075

Toronto Western Hospital
Toronto Western Hospital
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Maria Carmela Tartaglia, Site 0044

4166035483
Genge Partners Inc
Genge Partners Inc
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Angela Genge, Site 0248

514-891-8875
MoCA Clinic & Institute (Memory Clinic)
MoCA Clinic & Institute (Memory Clinic)
Greenfield Park, Quebec
Canada

Contact Study Team

Primary Contact

Ziad Nasreddine, Site 0113

4506727776
Ottawa Memory Clinic
Ottawa Memory Clinic
Ottawa, Ontario
Canada

Contact Study Team

Primary Contact

Robert Bisson, Site 0112

8195101000
Toronto Memory Program
Toronto Memory Program
Toronto, Ontario
Canada

Contact Study Team

Primary Contact

Manpreet Kaur, Site 0047

4163869761
Local Institution - 0193
Local Institution - 0193
Montreal, Quebec
Canada

Contact Study Team

Primary Contact

Site 0193

Study Sponsored By
Bristol-Myers Squibb
Participants Required
More Information
Study ID: NCT06268886