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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

2026-10-13

Healthy Volunteers

No

Interventions

DRUG

Trontinemab

Participants will receive IV trontinemab.

DRUG

Placebo

Participants will receive IV placebo.

Locations (34)

Irvine Center for Clinical Research

Irvine, California, United States

Healthy Brain Clinic

Long Beach, California, United States

Oakland Clinical

Oakland, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

K2 Medical Research, LLC

Maitland, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Charter Research - Winter Park/Orlando

Orlando, Florida, United States

Conquest Research - Lake Nona

Orlando, Florida, United States

Charter Research - Lady Lake/The Villages

The Villages, Florida, United States

Conquest Research, LLC

Winter Park, Florida, United States

Basil Clinical

Laurelton, New York, United States

Sana Research, LLC

Arlington, Virginia, United States

Hospital Italiano de Buenos Aires

Buenos Aires, Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales, Australia

KaRa Institute of Neurological Diseases

Macquarie Park, New South Wales, Australia

Kelowna Health and Memory Centre Ltd.

Kelowna, British Columbia, Canada

Toronto Memory Program

Toronto, Ontario, Canada

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, Guangdong, China

The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Yan'an University Xianyang Hospital

Xianyang, Shaanxi, China

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, China

Xuanwu Hospital, Capital Medical University

Beijing, China

Sir Run Run Shaw Hospital Zhejiang University

Hangzhou, China

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, China

Nanjing First Hospital

Nanjing, China

The Second Affiliated Hospital of Suzhou University

Suzhou, China

Taipei Veterans General Hospital

Taipei, Taiwan

Scottish Brain Sciences

Aberdeen, United Kingdom

Re:Cognition Health Birmingham

Birmingham, United Kingdom

Surrey and Borders NHS Foundation Trust

Chertsey, United Kingdom

Scottish Brain Sciences

Edinburgh, United Kingdom

Re:Cognition Health London

London, United Kingdom

Charing Cross Hospital

London, United Kingdom

Moorgreen Hospital

Southampton, United Kingdom