Trial intelligence / Profile preview

Trontinemab in early symptomatic Alzheimer's disease

NCT07170150Phase 3

Key facts

Status: Active, not recruiting
Start: Nov 2025
Primary completion: Feb 2028
Countries: 16
Sponsor: Roche
Modality: Monoclonal Antibodies

Drugs: trontinemab
Conditions: Alzheimer's disease (AD)

Overview

Phase 3, randomised, double-blind trial in Alzheimer's disease (AD) comparing Trontinemab with Placebo (2 arms). Primary endpoint: Clinical Dementia Rating Sum of Boxes at 72 weeks. Started Nov 2025; status: active, not recruiting.

Design

2 arms

Study design: RandomizedDouble-blind

Trontinemab
Participants will receive intravenous (IV) trontinemab.
Placebo
Participants will receive IV placebo.

Who it enrols

Participants with early symptomatic Alzheimer's disease (MCI to mild dementia) confirmed by amyloid PET or CSF biomarkers, MMSE >= 22, CDR-GS 0.5 or 1.0, and a study partner.

Endpoints

Primary

Clinical Dementia Rating Sum of Boxes72 weeks

Secondary

Alzheimer's Disease Assessment Scale-Cognition 1372 weeks
Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory72 weeks
Integrated Alzheimer's Disease Rating Scale72 weeks
Mini-Mental State Examination72 weeks
Clinical Dementia Rating Sum of Boxesup to 72w
Clinical Dementia Rating Global Score72 weeks
Adverse Events72 weeks
Columbia-Suicide Severity Rating Scale72 weeks

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