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NCT07169578PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

9/17/2025

Completion Date

6/7/2028

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).

Eligibility Criteria

Age Range: 50 years to 90 years

Inclusion Criteria: * Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner * Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted) * Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181/Aβ42 ratio may be used as an alternative option if amyloid PET is not available * Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4 * Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0 * Participant- and/or Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening * A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order * Availability of a "study partner" as defined by the protocol Exclusion Criteria: * Any evidence of a condition other than AD that may affect cognition * History or presence of clinically significant cerebrovascular disease * History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma * History or presence of clinically significant intracranial mass * MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI * Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments * History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death

Interventions

DRUG

Trontinemab

OTHER

Placebo

Interested in This Trial?

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Conditions

Alzheimers Disease

Locations

University of Alabama at Birmingham

Birmingham, Alabama 35233

United States

Banner Sun Health Research Institute

Sun City, Arizona 85351

United States

Irvine Center for Clinical Research

Irvine, California 92614

United States

Inglewood Clinicals

Los Angeles, California 90056

United States

UCSF - Memory and Aging Center

San Francisco, California 94158

United States

Syrentis Clinical Research

Santa Ana, California 92705

United States

K2 Medical Research - The Villages

Lady Lake, Florida 32159

United States

K2 Medical Research, LLC

Maitland, Florida 32751

United States

Renstar Medical Research

Ocala, Florida 34470

United States

Axiom Brain Health LLC

Tampa, Florida 33609

United States

Charter Research - Lady Lake/The Villages

The Villages, Florida 32162

United States

Alzheimer?s Research and Treatment Center

Wellington, Florida 33414

United States

Conquest Research, LLC

Winter Park, Florida 32789

United States

Alzheimer's Research and Treatment Center - Columbus

Columbus, Georgia 31904

United States

Accel Research Sites-NeuroStudies

Decatur, Georgia 30030

United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii 96817

United States

RE:Cognition (Chicago)

Chicago, Illinois 60611

United States

Tandem Clinical Research, LLC

Marrero, Louisiana 70072

United States

Brigham and Womens Hospital

Boston, Massachusetts 02115

United States

Boston Center for Memory

Newton, Massachusetts 02459

United States

Washington University School of Medicine

St Louis, Missouri 63110

United States

The Cognitive and Research Center of New Jersey

Ridgewood, New Jersey 07450

United States

Basil Clinical

Laurelton, New York 11413-2016

United States

Weill Cornell Medical College

New York, New York 10021

United States

Adams Clinical Harlem

New York, New York 10029

United States

Adams Clinical Bronx

The Bronx, New York 10461

United States

Triad Clinical Trials

Greensboro, North Carolina 27410

United States

Ohio State University

Columbus, Ohio 43221

United States

Butler Hospital

Providence, Rhode Island 02906

United States

Genesis Neuroscience Clinic

Knoxville, Tennessee 37909

United States

K2 Medical Research - Nashville

Nashville, Tennessee 37204

United States

Kerwin Research Center, LLC

Dallas, Texas 75231

United States

South Texas Research Institute - Edinburg

Edinburg, Texas 78539

United States

Re:Cognition Health - Houston

Houston, Texas 77030

United States

National Clinical Research Inc.-Richmond

Richmond, Virginia 23294

United States

Hospital Italiano

CABA, C1199ABA

Argentina

Sanatorio del Sur S.A.

San Miguel de Tucumán, T4000IDK

Argentina

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais 31270-901

Brazil

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul 90035-001

Brazil

Centro de Pesquisas Clinicas - CPCLIN

São Paulo, São Paulo 01228-200

Brazil

Richmond Clinical Trials

Richmond, British Columbia V6V 2L1

Canada

Baycrest Academy for Research and Education

North YORK, Ontario M6A 2E1

Canada

Toronto Memory Program

Toronto, Ontario M3B 2S7

Canada

Centricity East York

Toronto, Ontario M4G 3E8

Canada

Toronto Western Hospital

Toronto, Ontario M5T 2S8

Canada

Clinique Memoire de Montreal

Montreal, Quebec H2X 3B9

Canada

Alpha Recherche Clinique

Québec, G3K 2P8

Canada

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu 221002

China

Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality 200127

China

Peking University First Hospital

Beijing, 100034

China

Beijing Friendship Hospital Affiliated of Capital University of Medical Science

Beijing, 100050

China

Beijing Tiantan Hospital,Capital Medical University

Beijing, 100050

China

Peking University Sixth Hospital

Beijing, 100083

China

The First Hospital of Jilin University

Changchun, 130021

China

West China Hospital - Sichuan University

Chengdu, 610047

China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, 400016

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

Guangdong General Hospital

Guangzhou, 510030

China

The second Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510260

China

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

Hangzhou, 310016

China

The First Affiliated Hospital of Anhui Medical University

Hefei, 230022

China

Anhui Provincial Hospital

Hefei, 230088

China

Zhongda Hospital Affiliated to Southeast University

Nanjing, 210009

China

Nanjing Brain Hospital

Nanjing, 210029

China

Nanjing First Hospital

Nanjing, 210029

China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, 200025

China

Huashan Hospital, Fudan University

Shanghai, 200040

China

Shanghai First People's Hospital

Shanghai, 200080

China

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

Shanghai, 200233

China

Shanghai Pudong Hospital

Shanghai, 201399

China

The Second Affiliated Hospital of Soochow University

Suzhou, 215004

China

Tianjin Medical University General Hospital

Tianjin, 300052

China

Hôpital Broca

Le Kremlin Bicétre Cedex, 94275

France

Hopital B Roger Salengro

Lille, 59037

France

Hôpital de la Timone

Marseille, 13385

France

Hopital Lariboisiere

Paris, 75475

France

CHU Rennes - Hopital Pontchaillou

Rennes, 35033

France

Gerontopole

Toulouse, 31059

France

CHRU - Hôpital Bretonneau

Tours, 37000

France

Hôpital de Brabois

Vandœuvre-lès-Nancy, 54500

France

Hopital des Charpennes

Villeurbanne, 69100

France

Uniklinik RWTH Aachen

Aachen, 52074

Germany

Zentrum für klinische Forschung Dr. med. Irma Schöll

Bad Homburg, 61348

Germany

Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie

Bayreuth, 95445

Germany

St. Josef-Hospital, Klinik für Neurologie

Bochum, 44791

Germany

Gesundheit Nord, Klinikum Bremen-Ost

Bremen, 28325

Germany

NeuroCentrum Odenwald

Erbach/Odenwald, 64711

Germany

Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

Freiburg im Breisgau, 79106

Germany

MVZ Rheumatologie und Autoimummedizin Hamburg GmbH

Hamburg, 20095

Germany

Neurology UKSH Campus Kiel

Kiel, 24105

Germany

Klinikum rechts der Isar der TU München

München, 81675

Germany

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

Steglitz, 12163

Germany

Krankenhaus der Barmherzigen Brüder Trier

Trier, 54292

Germany

Universitätsklinikum Ulm

Ulm, 89081

Germany

Fondazione Santa Lucia IRCCS

Rome, Lazio 00179

Italy

Umberto I Policlinico di Roma-Università di Roma La Sapienza

Rome, Lazio 00185

Italy

Azienda Ospedaliero Universitaria San Martino

Genoa, Liguria 16132

Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy 25123

Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy 20132

Italy

Kyoto University Hospital

Kyoto, 606-8507

Japan

National Hospital Organization Utano National Hospital

Kyoto, 616-8255

Japan

Mishuku Hospital

Meguro-Ku, 153-0051

Japan

Mie University Hospital

Mie, 514-8507

Japan

Memory Clinic Ochanomizu

Tokyo, 113-0034

Japan

Keio University Hospital

Tokyo, 160-8582

Japan

Tokyo Metropolitan Institute for Geriatrics and Gerontology

Tokyo, 173-0015

Japan

National Center of Neurology and Psychiatry

Tokyo, 187-8551

Japan

Federation of National Public Service Personnel Mutual Aid Associations Tachikawa Hospital

Tokyo, 190-8531

Japan

P-One Clinic

Tokyo, 192-0071

Japan

Yamagata Tokusyukai Hospital

Yamagata, 990-0834

Japan

Centrum Medyczne Neuromed Sp. z.o.o.

Bydgoszcz, 85-163

Poland

NEURO-CARE Sp. z o.o. Sp. Komandytowa

Katowice, 40-749

Poland

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

Krakow, 31-505

Poland

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, 20-410

Poland

Nmedis sp. z o.o.

Rzeszów, 35-323

Poland

ETG Neuroscience Sp. z o.o.

Warsaw, 02-677

Poland

Centrum Leczenia Zaburzen Pamieci

Warsaw, 03-839

Poland

NZOZ WCA

Wroc?aw, 53-659

Poland

SPSK nr 1

Zabrze, 41-800

Poland

Hospital General De Catalunya

Sant Cugat del Vallès, Barcelona 8195

Spain

Hospital Mutua De Terrasa

Terrassa, Barcelona 08222

Spain

Policlínica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa 20014

Spain

Hospital Universitario de Santa Maria

Lleida, Lerida 25198

Spain

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid 28223

Spain

Hospital Vall d'Hebron

Barcelona, 08035

Spain

Hospital Universitario Reina Sofia

Córdoba, 14004

Spain

Hospital Universitario de la Princesa

Madrid, 28006

Spain

Hospital Universitario Dr. Peset

Valencia, 46017

Spain

Kaohsiung Medical University Hospital

Kaohsiung City, 807

Taiwan

Taipei Medical University ?Shuang Ho Hospital

New Taipei City, 23561

Taiwan

China Medical University Hospital

North Dist., 40447

Taiwan

Taichung Veterans General Hospital

Taichung, 40705

Taiwan

National Taiwan University Hospital

Taipei, 100

Taiwan

Taipei Veterans General Hospital

Taipei, 11217

Taiwan

Chang Gung Medical Foundation Linkou Branch

Taoyuan City, 333

Taiwan

Lynfield Mount hospital

Bradford, BD9 6DP

United Kingdom

Recognition Health Bristol

Bristol, BS32 4SY

United Kingdom

Surrey and Borders NHS Foundation Trust

Chertsey, KT16 9AU

United Kingdom

Department of Old Age Psychiatry Kings College

London, SE5 8AF

United Kingdom

RE:Cognition Health

London, W1G 8TA

United Kingdom

Charing Cross Hospital

London, W6 8RF

United Kingdom

Campus for Ageing & Vitality

Newcastle, NE4 5PL

United Kingdom

Tees,Esk and Wear Valleys NHS Foundation Trust

York, YO31 8TA

United Kingdom