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 OnsetThe 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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Conditions de participation
-
Sexe:
ALL -
Âges admissibles:
60 to 80
Critères de participation
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.
Lieu de l'étude
The Rotman Research Institute at Baycrest
The Rotman Research Institute at BaycrestToronto, Ontario
Canada
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Howard Chertkow, Site 0109
41678525003078Local Institution - 0075
Local Institution - 0075Montreal, Quebec
Canada
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Site 0075
Toronto Western Hospital
Toronto Western HospitalToronto, Ontario
Canada
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Maria Carmela Tartaglia, Site 0044
4166035483Genge Partners Inc
Genge Partners IncMontreal, Quebec
Canada
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Angela Genge, Site 0248
514-891-8875MoCA Clinic & Institute (Memory Clinic)
MoCA Clinic & Institute (Memory Clinic)Greenfield Park, Quebec
Canada
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Ziad Nasreddine, Site 0113
4506727776Ottawa Memory Clinic
Ottawa Memory ClinicOttawa, Ontario
Canada
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Robert Bisson, Site 0112
8195101000Toronto Memory Program
Toronto Memory ProgramToronto, Ontario
Canada
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Manpreet Kaur, Site 0047
4163869761Local Institution - 0193
Local Institution - 0193Montreal, Quebec
Canada
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Site 0193
- Étude parrainée par
- Bristol-Myers Squibb
- Participants recherchés
- Plus d'informations
- ID de l'étude:
NCT06268886