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Clinical Trials in Spain / NCT06268886
Active, not recruiting Phase 2

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

NCT06268886 · tracked via the Priya Life Science Spain tracker
Sponsor
Bristol-Myers Squibb
Phase
Phase 2
Started
2024-03-20
Last updated
2025-07-24

Condition(s) studied

Alzheimer Disease, Early Onset

Investigational drug(s) / intervention(s)

BMS-986446 →Placebo

BMS-986446: Specified dose on specified days

Placebo: Specified dose on specified days

Study 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.

Eligibility

Sex
ALL
Min age
50 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Change from baseline in brain tau deposition as measured by tau positron emission tomography (PET) — At week 76

Trial sites (176)

FacilityCityRegionStatus
Local Institution - 0068 Chandler Arizona
Local Institution - 0102 Gilbert Arizona
Local Institution - 0019 Phoenix Arizona
Local Institution - 0018 Scottsdale Arizona
Local Institution - 0026 Scottsdale Arizona
Local Institution - 0077 Tucson Arizona
Local Institution - 0038 Tucson Arizona
Local Institution - 0164 Encino California
Local Institution - 0139 Fullerton California
Local Institution - 0191 Irvine California
Local Institution - 0234 Long Beach California
Local Institution - 0142 Los Alamitos California
Local Institution - 0037 Napa California
Local Institution - 0209 Sacramento California
Local Institution - 0052 San Francisco California
Local Institution - 0137 Santa Ana California
Local Institution - 0046 Sherman Oaks California
Local Institution - 0106 Danbury Connecticut
Local Institution - 0148 New Haven Connecticut
Local Institution - 0056 New Haven Connecticut
Local Institution - 0153 Stamford Connecticut
Local Institution - 0022 Altamonte Springs Florida
Local Institution - 0048 Atlantis Florida
Local Institution - 0228 Boca Raton Florida
Local Institution - 0250 Boca Raton Florida
Local Institution - 0224 Bradenton Florida
Local Institution - 0020 Clermont Florida
Local Institution - 0009 Daytona Beach Florida
Local Institution - 0213 Fort Myers Florida
Local Institution - 0059 Greenacres City Florida
Local Institution - 0207 Hialeah Florida
Local Institution - 0212 Hialeah Florida
Local Institution - 0198 Hialeah Florida
Local Institution - 0151 Lady Lake Florida
Local Institution - 0146 Lakeland Florida
Local Institution - 0192 Maitland Florida
Local Institution - 0143 Maitland Florida
Local Institution - 0027 Merritt Island Florida
Local Institution - 0203 Miami Florida
Local Institution - 0058 Miami Florida

+ 136 more sites — see the full list on the official registry below.

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First-Line Systemic Therapies in Advanced Renal Cell Carcinoma in Spain Active, not recruiting
A Study to Assess BMS-986458 Alone and in Combination With Anti-lymphoma Agents in Relapsed/Refractory Non-Hodgkin Lymphomas Recruiting
A Study to Compare the Efficacy of Nivolumab and Relatlimab Plus Chemotherapy vs Pembrolizumab Plus Chemotherapy for Stage IV/Recurrent Non-squamous Non-small Cell Lung Cancer With PD-L1 Expression ≥ 1% Recruiting

Other trials for the same condition

Senolytic Therapy to Modulate the Progression of Alzheimer's Disease (SToMP-AD) Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06268886 on ClinicalTrials.gov ↗ ← All trials in Spain