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NCT07170150PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

11/12/2025

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

Banner Alzheimer?s Institute

Phoenix, Arizona 85006

United States

Sun Valley Research Center, Inc.

Imperial, California 92251

United States

Healthy Brain Clinic

Long Beach, California 90804

United States

Oakland Clinical

Oakland, California 94609

United States

Riverside Clinical

Riverside, California 92506

United States

Cenexel California Neuroscience Research, LLC

Sherman Oaks, California 91403

United States

Yale University

New Haven, Connecticut 06510

United States

JEM Research LLC

Atlantis, Florida 33462

United States

K2 Medical Research-Winter Garden

Clermont, Florida 34711

United States

Visionary Investigators Network- Neurology Aventura

Miami, Florida 33133

United States

Charter Research - Winter Park/Orlando

Orlando, Florida 32803

United States

Conquest Research - Lake Nona

Orlando, Florida 32832

United States

Alzheimer's Research and Treatment Center

Stuart, Florida 34996

United States

CenExel iResearch, LLC

Decatur, Georgia 30030

United States

Center for Advanced Research & Education

Gainesville, Georgia 30501

United States

Great Lakes Clinical Trials Chicago d/b/a Flourish Research Andersonville

Chicago, Illinois 60640

United States

Adams Clinical Boston

Boston, Massachusetts 02116

United States

Adams Clinical Watertown

Watertown, Massachusetts 02472

United States

Quest Research Institute

Farmington Hills, Michigan 48334

United States

University of Nebraska Medical Center

Omaha, Nebraska 68198-8440

United States

The Cognitive and Research Center of New Jersey

Springfield, New Jersey 07081

United States

IMA Clinical Research - Albuquerque

Albuquerque, New Mexico 87109

United States

AD-CARE, University of Rochester Medical Center

Rochester, New York 14620

United States

Summit Research Network Inc.

Portland, Oregon 97210

United States

Flourish Research ? Philadelphia

Plymouth Meeting, Pennsylvania 19462

United States

Palmetto Clinical Trials

Summerville, South Carolina 29485

United States

Gadolin Research, LLC

Beaumont, Texas 77702

United States

Kerwin Medical Center

Dallas, Texas 75216

United States

Re:Cognition Health - Fort Worth

Fort Worth, Texas 76104

United States

Mt.Olympus Medical Research

Katy, Texas 77450

United States

El Faro Health and Therapeutics

Rio Grande City, Texas 78582

United States

Sana Research, LLC

Arlington, Virginia 22205

United States

Re:Cognition Health

Fairfax, Virginia 22031

United States

INECO Neurociencias Orono

Rosario, Santa Fe Province S2000DTC

Argentina

CIER

C. A. B. A., C1055AAF

Argentina

Fundacion Scherbovsky

Mendoza, 5500

Argentina

Royal Prince Alfred Hospital

Camperdown, New South Wales 2050

Australia

Southern Neurology

Kogarah, New South Wales 2217

Australia

KaRa Institute of Neurological Diseases

Macquarie Park, New South Wales 2113

Australia

Flinders Medical Centre

Bedford Park, South Australia 5042

Australia

Queen Elizabeth Hospital

Woodville, South Australia 5011

Australia

Box Hill Hospital

Box Hill, Victoria 3128

Australia

Austin Health

Heidelberg, Victoria 3084

Australia

Alfred Hospital

Melbourne, Victoria 3004

Australia

Alzheimer?s Research Australia

Nedlands, Western Australia 6009

Australia

L2 Ip Instituto de Pesquisas Clinicas Ltda ME

Brasília, Federal District 70200-730

Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná 81210-310

Brazil

Clinica Clinilive ltda

Maringá, Paraná 87013-250

Brazil

Instituto do Cerebro do Rio Grande do Sul

Porto Alegre, Rio Grande do Sul 90610-000

Brazil

Clinica Neurologica

Joinville, Santa Catarina 89202-190

Brazil

CEMEC - Centro Multidisciplinar de Estudos Clínicos

São Bernardo do Campo, São Paulo 09715-090

Brazil

Okanagan Clinical Trials

Kelowna, British Columbia V1Y 1Z9

Canada

Centricity Research

Halifax, Nova Scotia B3S 1N2

Canada

Parkwood Institute Main Building

London, Ontario N6C0A7

Canada

The Ottawa Memory Clinic

Ottawa, Ontario K1Z 1G3

Canada

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario K9H 2P4

Canada

Sunnybrook Health Sciences Centre

Toronto, Ontario M4N 3M5

Canada

St. Michael's Hospital

Toronto, Ontario M5B 1W8

Canada

Genge Partners Inc.

Montreal, Quebec H4A 3T2

Canada

Aalborg Universitetshospital

Aalborg, 9000

Denmark

Aarhus Universitetshospital Skejby

Aarhus N, 8200

Denmark

Rigshospitalet, Hukommelsesklinikken

København Ø, 2100

Denmark

CHU Amiens Hopital Sud

Amiens Cedex1, 80054

France

Centre Hospitalier Universitaire de Bordeaux Hopital Pellegrin

Bordeaux, 33076

France

Groupement Hospitalier Est - Hôpital Neurologique

Bron, 69677

France

CHU Dupruytren - Limoges

Limoges, 87042

France

Hopital Gui de Chauliac

Montpellier, 34295

France

Ch Pitie Salpetriere

Paris, 75651

France

CHU de Rouen Hopital

Rouen, 76031

France

Hop Guillaume Et Rene Laennec

Saint-Herblain, 44800

France

Hôpital Robertsau

Strasbourg, 67000

France

Universitaetsklinikum Erlangen

Erlangen, Bavaria 91054

Germany

Ambulates Gesundheitszentrum der Charité GmbH

Berlin, 12200

Germany

ECRC Experimental and Clinical Research Center, Charité Campus Berlin Buch, Memory Clinic

Berlin, 13125

Germany

German Center for Neurodegenerative Diseases (DZNE)

Bonn, 53127

Germany

Universitätsklinikum Köln

Cologne, 50937

Germany

Medizinische Fakultät Carl Gustav Carus

Dresden, 01307

Germany

Universitätsklinikum des Saarlandes Klinik f. Psychiatrie und Psychotherapie

Homburg/Saar, 66421

Germany

Universitätsklinikum Jena, Klinik für Neurologie

Jena, 07747

Germany

Universität Leipzig

Leipzig, 04103

Germany

Otto-von-Guericke-Universität Magdeburg

Magdeburg, 39120

Germany

Zentralinstitut für Seelische Gesundheit Abt.Gerontopsychiatrie

Mannheim, 68159

Germany

LMU Klinikum, Neurologische Klinik und Poliklinik

München, 81377

Germany

Ludwig-Maximilians-Univ.

München, 81377

Germany

Universitätsklinikum Münster

Münster, 48149

Germany

Neuropraxis München Süd

Unterhaching, 82008

Germany

A. O. U. Federico II

Naples, Campania 80131

Italy

Nuovo Ospedale Civile S. Agostino-Estense

Modena, Emilia-Romagna 41126

Italy

Policlinico Universitario Agostino Gemelli

Rome, Lazio 00168

Italy

Ospedale Isola Tiberina - Gemelli Isola

Rome, Lazio 00186

Italy

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria 06156

Italy

Brain Attack Center Ota Memorial Hospital

Hiroshima, 720-0825

Japan

National Hospital Organization Hiroshima-Nishi Medical Center

Hiroshima, 739-0696

Japan

Kobe University Hospital

Hyōgo, 650-0017

Japan

Kagawa University Hospital

Kagawa, 761-0793

Japan

Kochi Medical School Hospital

Kochi, 783-8505

Japan

Okayama City Hospital

Okayama, 700-8557

Japan

Rijikai Medical Corporation Katayama Medical Clinic

Okayama, 710-0813

Japan

Kotobuki Social Medical Corporation Tominaga Clinic

Osaka, 556-0015

Japan

The University of Tokyo Hospital

Tokyo, 113-8655

Japan

Higashi-Shinjuku Clinic

Tokyo, 169-0072

Japan

Brain Research Center Den Bosch

's-Hertogenbosch, 5223 LA

Netherlands

Brain Research Center B.V

Amsterdam, 1081 GN

Netherlands

Brain Research Center Zwolle

Zwolle, 8025AZ

Netherlands

O?rodek Badawczo-Naukowo-Dydaktyczny Chorób Ot?piennych w ?cinawie

?cinawa, 59-330

Poland

ProNeuro Centrum Medyczne

?ory, 44-240

Poland

Uniwersytet Medyczny w Lodzi

?ód?, 92-216

Poland

Syberka-ClinHouse Sp. z o.o.

B?dzin, 42-500

Poland

Podlaskie Centrum Psychogeriatrii

Bia?ystok, 15-756

Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, 80-214

Poland

Szpital Uniwersytecki w Krakowie

Krakow, 30-688

Poland

Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa

Późna, 61-731

Poland

Centrum Medyczne "MEDYK"

Rzeszów, 35-326

Poland

Senior Sp. Z O.O. Poradnia Psychogeriatryczna

Sopot, 81-855

Poland

NeuroProtect

Warsaw, 01-684

Poland

Pusan National University Hospital

Busan, 602-739

South Korea

Chonnam National University Hospital

Gwangju, 61469

South Korea

Ajou University Medical Center

Gyeonggi-do, 16499

South Korea

St. Vincent's Hospital

Gyeonggi-do, 442-723

South Korea

Gachon University Gil Medical Center

Incheon, 21565

South Korea

Inha University Hospital

Incheon, 22332

South Korea

Seoul National University Bundang Hospital

Seongnam-si, 463-707

South Korea

Hanyang University Seoul Hospital

Seoul, 04763

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Ewha Womans University Hospital (Seoul)

Seoul, 07804

South Korea

Korea University Guro Hospital

Seoul, 08308

South Korea

Hospital Universitario Marques de Valdecilla

Santander, Cantabria 39011

Spain

Fundación ACE

Barcelona, 08028

Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, 08041

Spain

Hospital Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 de Octubre

Madrid, 28041

Spain

Hospital Victoria Eugenia

Seville, 41009

Spain

Hospital Virgen del Rocío

Seville, 41013

Spain

Hospital Universitario la Fe

Valencia, 46026

Spain

Inselspital Bern Medizin Neurologie

Bern, 3010

Switzerland

Hôpitaux universitaires de Genève

Geneva, 1211

Switzerland

CHUV Lausanne Méd.Neurologie

Lausanne, 1011

Switzerland

Ospedale Regionale di Lugano - Civico

Lugano, 6903

Switzerland

ReMind UK

Bath, BA1 3NG

United Kingdom

Re:Cognition Health Birmingham

Birmingham, B16 8QQ

United Kingdom

Scottish Brain Sciences

Edinburgh, EH12 9DQ

United Kingdom

Queen Elizabeth University Hospital Glasgow

Glasgow, G51 4TF

United Kingdom

St George?s Hospital

London, SW17 ORE

United Kingdom

RE:Cognition Health

London, W1G 8TA

United Kingdom

UCL Institute of Neurology

London, WC1N 3BG

United Kingdom

Manchester Mental Health and Social Care Trust

Manchester, M13 9WL

United Kingdom

Warneford Hospital

Oxford, OX3 7JX

United Kingdom

Lancashire and South Cumbria NHS Foundation Trust

Preston, PR2 8DW

United Kingdom

Southampton University Hospitals NHS Trust

Southampton, SO16 6YD

United Kingdom