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RECRUITING
NCT07717411
PHASE3

A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the efficacy and safety of trontinemab in participants with biomarker evidence of Alzheimer's Disease (AD) pathology but with no cognitive or functional impairment, who are at risk for progression to mild cognitive impairment (MCI) due to AD or dementia due to AD.

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease

Key Details

Gender

All

Age Range

55 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

1600

Start Date

2026-11-30

Completion Date

2032-09-03

Last Updated

2026-09-10

Healthy Volunteers

No

Interventions

DRUG

Trontinemab

Participants will receive IV trontinemab.

DRUG

Placebo

Participants will receive IV placebo.

Locations (7)

Irvine Center for Clinical Research

Irvine, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

K2 Medical Research, LLC

Maitland, Florida, United States

Basil Clinical

Laurelton, New York, United States

Toronto Memory Program

Toronto, Ontario, Canada

Xuanwu Hospital, Capital Medical University

Beijing, China

Surrey and Borders NHS Foundation Trust

Chertsey, United Kingdom