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ACTIVE NOT RECRUITING
NCT07169578
PHASE3

A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \[MCI\] to mild dementia due to AD).

Official title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1101

Start Date

2025-09-17

Completion Date

2028-02-16

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DRUG

Trontinemab

Participants will receive IV trontinemab.

OTHER

Placebo

Participants will receive IV placebo.

Locations (142)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Irvine Center for Clinical Research

Irvine, California, United States

Inglewood Clinicals

Los Angeles, California, United States

UCSF - Memory and Aging Center

San Francisco, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

K2 Medical Research - The Villages

Lady Lake, Florida, United States

K2 Medical Research, LLC

Maitland, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Axiom Brain Health LLC

Tampa, Florida, United States

Charter Research - Lady Lake/The Villages

The Villages, Florida, United States

Alzheimer?s Research and Treatment Center

Wellington, Florida, United States

Conquest Research, LLC

Winter Park, Florida, United States

Alzheimer's Research and Treatment Center - Columbus

Columbus, Georgia, United States

Accel Research Sites-NeuroStudies

Decatur, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

RE:Cognition (Chicago)

Chicago, Illinois, United States

Tandem Clinical Research, LLC

Marrero, Louisiana, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Boston Center for Memory

Newton, Massachusetts, United States

Washington University School of Medicine

St Louis, Missouri, United States

The Cognitive and Research Center of New Jersey

Ridgewood, New Jersey, United States

Basil Clinical

Laurelton, New York, United States

Weill Cornell Medical College

New York, New York, United States

Adams Clinical Harlem

New York, New York, United States

Adams Clinical Bronx

The Bronx, New York, United States

Triad Clinical Trials

Greensboro, North Carolina, United States

Ohio State University

Columbus, Ohio, United States

Butler Hospital

Providence, Rhode Island, United States

Genesis Neuroscience Clinic

Knoxville, Tennessee, United States

K2 Medical Research - Nashville

Nashville, Tennessee, United States

Kerwin Research Center, LLC

Dallas, Texas, United States

South Texas Research Institute - Edinburg

Edinburg, Texas, United States

Re:Cognition Health - Houston

Houston, Texas, United States

National Clinical Research Inc.-Richmond

Richmond, Virginia, United States

Hospital Italiano

CABA, Argentina

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais, Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo, Brazil

Richmond Clinical Trials

Richmond, British Columbia, Canada

Baycrest Academy for Research and Education

North YORK, Ontario, Canada

Toronto Memory Program

Toronto, Ontario, Canada

Centricity East York

Toronto, Ontario, Canada

Toronto Western Hospital

Toronto, Ontario, Canada

Clinique Memoire de Montreal

Montreal, Quebec, Canada

Alpha Recherche Clinique

Québec, Canada

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Peking University First Hospital

Beijing, China

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, China

Beijing Tiantan Hospital,Capital Medical University

Beijing, China

Peking University Sixth Hospital

Beijing, China

The First Hospital of Jilin University

Changchun, China

West China Hospital - Sichuan University

Chengdu, China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China

Fujian Medical University Union Hospital

Fuzhou, China

Guangdong General Hospital

Guangzhou, China

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University

Hangzhou, China

The First Affiliated Hospital of Anhui Medical University

Hefei, China

Anhui Provincial Hospital

Hefei, China

Zhongda Hospital Affiliated to Southeast University

Nanjing, China

Nanjing Brain Hospital

Nanjing, China

Nanjing First Hospital

Nanjing, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, China

Huashan Hospital, Fudan University

Shanghai, China

Shanghai First People's Hospital

Shanghai, China

Shanghai Sixth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, China

Shanghai Pudong Hospital

Shanghai, China

The Second Affiliated Hospital of Soochow University

Suzhou, China

Tianjin Medical University General Hospital

Tianjin, China

Hôpital Broca

Le Kremlin Bicétre Cedex, France

Hopital B Roger Salengro

Lille, France

Hôpital de la Timone

Marseille, France

Hopital Lariboisiere

Paris, France

CHU Rennes - Hopital Pontchaillou

Rennes, France

Gerontopole

Toulouse, France

CHRU - Hôpital Bretonneau

Tours, France

Hôpital de Brabois

Vandœuvre-lès-Nancy, France

Hopital des Charpennes

Villeurbanne, France

Uniklinik RWTH Aachen

Aachen, Germany

Zentrum für klinische Forschung Dr. med. Irma Schöll

Bad Homburg, Germany

Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie

Bayreuth, Germany

St. Josef-Hospital, Klinik für Neurologie

Bochum, Germany

Gesundheit Nord, Klinikum Bremen-Ost

Bremen, Germany

NeuroCentrum Odenwald

Erbach/Odenwald, Germany

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

Freiburg im Breisgau, Germany

MVZ Rheumatologie und Autoimummedizin Hamburg GmbH

Hamburg, Germany

Neurology UKSH Campus Kiel

Kiel, Germany

Klinikum rechts der Isar der TU München

München, Germany

Gemeinschaftspraxis Dr. Wolfram von Pannwitz, MBA & Dr. med. Marie Perle Brinckmann

Steglitz, Germany

Krankenhaus der Barmherzigen Brüder Trier

Trier, Germany

Universitätsklinikum Ulm

Ulm, Germany

Fondazione Santa Lucia IRCCS

Rome, Lazio, Italy

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio, Italy

Azienda Ospedaliero Universitaria San Martino

Genoa, Liguria, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

Kyoto University Hospital

Kyoto, Japan

National Hospital Organization Utano National Hospital

Kyoto, Japan

And 42 more locations on ClinicalTrials.gov