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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

Phase 2
Active, not recruiting
Conditions
Alzheimer Disease, Early Onset
Interventions
Other: Placebo
Registration Number
NCT06268886
Lead Sponsor
Bristol-Myers Squibb
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ACTIVE_NOT_RECRUITING
Sex
All
Target Recruitment
310
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
PlaceboPlacebo-
BMS-986446 Dose BBMS-986446-
BMS-986446 Dose ABMS-986446-
Primary Outcome Measures
NameTimeMethod
Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET)At week 76
Secondary Outcome Measures
NameTimeMethod
Change from baseline in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) scoreAt week 76
Change from baseline in integrated Alzheimer's Disease Rating Scale (iADRS) scoreAt week 76
Change from baseline in Alzheimer's Disease Assessment Scale-Cognitive subscale (ADASCog14) scoreAt week 76
Change from baseline in Alzheimer's Disease Cooperative Study-instrumental Activities of Daily Living scale (ADCS-iADL) scoreAt week 76
Change from baseline in Mini Mental State Examination (MMSE) scoreAt week 76

Trial Locations

Locations (176)

Local Institution - 0068

🇺🇸

Chandler, Arizona, United States

Local Institution - 0102

🇺🇸

Gilbert, Arizona, United States

Local Institution - 0019

🇺🇸

Phoenix, Arizona, United States

Local Institution - 0018

🇺🇸

Scottsdale, Arizona, United States

Local Institution - 0026

🇺🇸

Scottsdale, Arizona, United States

Local Institution - 0077

🇺🇸

Tucson, Arizona, United States

Local Institution - 0038

🇺🇸

Tucson, Arizona, United States

Local Institution - 0164

🇺🇸

Encino, California, United States

Local Institution - 0139

🇺🇸

Fullerton, California, United States

Local Institution - 0191

🇺🇸

Irvine, California, United States

Scroll for more (166 remaining)
Local Institution - 0068
🇺🇸Chandler, Arizona, United States

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