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ACTIVE NOT RECRUITING
NCT03887455
PHASE3

A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease

Sponsor: Eisai Inc.

View on ClinicalTrials.gov

Summary

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term safety and tolerability of lecanemab in participants with EAD in the Extension Phase and whether the long-term effects of lecanemab as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase. Extension Phase Part B will continue dosing with lecanemab in countries where lecanemab may not be commercially available.

Official title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

1906

Start Date

2019-03-27

Completion Date

2026-12-31

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

Lecanemab IV

Administered as IV infusion.

DRUG

Placebo

Biweekly (once every 2 weeks) administered as IVinfusion.

DRUG

Lecanemab SC

Administered weekly as a SC injection.

Locations (247)

Banner Alzheimer's Institute- Clinical Trials Department

Phoenix, Arizona, United States

Banner Sun Health Research

Sun City, Arizona, United States

Neurological Associates of Tucson dba Center for Neurosciences

Tucson, Arizona, United States

Neurology Center of North Orange County

Fullerton, California, United States

Irvine Clinical Research

Irvine, California, United States

University of California - Los Angeles

Los Angeles, California, United States

Pacific Neuroscience Medical Group

Oxnard, California, United States

Stanford University Medical Center

Palo Alto, California, United States

Pacific Research Network, Inc

San Diego, California, United States

Sharp Neurocognitive Research Center

San Diego, California, United States

UCSF Memory and Aging Center

San Francisco, California, United States

Apex Research Institute

Santa Ana, California, United States

St Joseph Heritage Healthcare

Santa Rosa, California, United States

ImmunoE Research Center

Centennial, Colorado, United States

Mile High Research Center

Denver, Colorado, United States

Associated Neurologists of Southern Connecticut

Fairfield, Connecticut, United States

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

Yale University School Of Medicine

New Haven, Connecticut, United States

Research Center for Clinical Studies, Inc.

Norwalk, Connecticut, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

JEM Research Institute

Atlantis, Florida, United States

Bradenton Research Center, Inc.

Bradenton, Florida, United States

Linfritz Research Institute, Inc.

Coral Gables, Florida, United States

Brain Matters Research

Delray Beach, Florida, United States

Neuropsychiatric Research Center of Southwest FL

Fort Myers, Florida, United States

Infinity Clinical Research

Hollywood, Florida, United States

Clincloud, LLC

Maitland, Florida, United States

BioMed Research Institute

Miami, Florida, United States

Finlay Medical Research

Miami, Florida, United States

CCM Clinical Research Group

Miami, Florida, United States

Advance Medical Research Center

Miami, Florida, United States

Advanced Clinical Research Network

Miami, Florida, United States

Gonzalez MD & Aswad MD Health Services

Miami, Florida, United States

Vitae Research Center

Miami, Florida, United States

Miami Jewish Health Systems

Miami, Florida, United States

Allied Biomedical Research (Clinical Trial)

Miami, Florida, United States

Pharmax Research of South Florida, Inc

Miami, Florida, United States

IMIC, Inc.

Miami, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Galiz Research

Miami Springs, Florida, United States

Renstar Medical Research

Ocala, Florida, United States

Synexus Clinical Research US, Inc.

Orlando, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, United States

Quantum Laboratories Inc.

Pompano Beach, Florida, United States

Neurostudies, Inc.

Port Charlotte, Florida, United States

Progressive Medical Research

Port Orange, Florida, United States

Alzheimer's Research and Treatment Center

Stuart, Florida, United States

Infinity Clinical Research, LLC

Sunrise, Florida, United States

Stedman Clinical Trials, LLC

Tampa, Florida, United States

USF Suncoast Gerontology Center

Tampa, Florida, United States

Charter Research

The Villages, Florida, United States

Synexus Clinical Research

The Villages, Florida, United States

Alzheimer's Research and Treatment Center

Wellington, Florida, United States

Premiere Research Institute, West Palm

West Palm Beach, Florida, United States

Emory University Cognitive Neurology Clinic & ADRC

Atlanta, Georgia, United States

Columbus Memory Center

Columbus, Georgia, United States

iResearch Atlanta, LLC

Decatur, Georgia, United States

NeuroStudies.net, LLC

Decatur, Georgia, United States

Hawaii Pacific Neuroscience

Honolulu, Hawaii, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Fort Wayne Neurological Center

Fort Wayne, Indiana, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Kansas Medical Center Research Institute

Kansas City, Kansas, United States

KU Wichita Center for Clinical Research

Wichita, Kansas, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

McLean Hospital

Belmont, Massachusetts, United States

Brigham and Women's Hospital

Boston, Massachusetts, United States

ActivMed Practices & Research

Methuen, Massachusetts, United States

Boston Center for Memory

Newton, Massachusetts, United States

Donald S. Marks, MD. P.C.

Plymouth, Massachusetts, United States

Hattiesburg Clinic

Hattiesburg, Mississippi, United States

Washington University

St Louis, Missouri, United States

Cleveland Clinic Lou Ruvo Center for Brain Health

Las Vegas, Nevada, United States

Las Vegas Medical Research

Las Vegas, Nevada, United States

Advanced Memory Research Institute of NJ, PC

Toms River, New Jersey, United States

Bio Behavioral Health

Toms River, New Jersey, United States

Albany Medical College

Albany, New York, United States

Neurological Associates of Albany, PC

Albany, New York, United States

New York University Medical Center PRIME

New York, New York, United States

Neurological Institute of New York

New York, New York, United States

University of Rochester

Rochester, New York, United States

ANI Neurology, PLLC d/b/a Alzheimer's Memory Center

Matthews, North Carolina, United States

Raleigh Neurology Associates, P.A. - Research Department

Raleigh, North Carolina, United States

PMG Research of Winston Salem

Winston-Salem, North Carolina, United States

NeuroScience Research Center LLC

Canton, Ohio, United States

Cleveland Clinic

Cleveland, Ohio, United States

Columbs Neuroscience, LLC

Columbus, Ohio, United States

Ohio State University

Columbus, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Summit Research Network (OR) Inc.

Portland, Oregon, United States

Neural Net Research, LLC

Portland, Oregon, United States

Oregon Health & Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Keystone Clinical Studies, LLC

Plymouth Meeting, Pennsylvania, United States

Rhode Island Mood & Memory Research Institute

East Providence, Rhode Island, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Butler Hospital - Memory and Aging Program

Providence, Rhode Island, United States

Ralph H. Johnson VA Health Care System

North Charleston, South Carolina, United States

Coastal Neurology, P.A.

Port Royal, South Carolina, United States

Neurology Clinic, P.C.

Cordova, Tennessee, United States

Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company

Knoxville, Tennessee, United States

Senior Adult Specialty Research

Austin, Texas, United States

Texas Neurology, PA

Dallas, Texas, United States

Kerwin Research Center

Dallas, Texas, United States

Baylor College of Medicine AD and Memory Disorders Center

Houston, Texas, United States

Clinical Trial Network

Houston, Texas, United States

DBA The Memory Clinic

Bennington, Vermont, United States

National Clinical Research Inc.-Richmond

Richmond, Virginia, United States

Kingfisher Cooperative LLC

Spokane, Washington, United States

St Vincent's Hospital - Translational Research Centre

Darlinghurst, New South Wales, Australia

KaRa Institute of Neurological Diseases

Macquarie Park, New South Wales, Australia

The Prince Charles Hospital/Internal Medicine & Dementia Research Unit

Chermside Brisbane, Queensland, Australia

Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital

Woodville South, Adelaid, South Australia, Australia

Austin Health - Medical and Cognitive Research Unit

Ivanhoe, Victoria, Australia

HammondCare Malvern Clinical Trials Unit

Malvern, Victoria, Australia

Australian Alzheimer's Research Foundation

Nedlands, Western Australia, Australia

Okanagan Clinical Trials

Kelowna, British Columbia, Canada

Health Research

West Vancouver, British Columbia, Canada

Centricity Research Halifax

Halifax, Nova Scotia, Canada

True North Clinical Research Kentville, Inc.

Kentville, Nova Scotia, Canada

St. Joseph's HC- Parkwood Institute

London, Ontario, Canada

Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic

Ottawa, Ontario, Canada

Kawartha Centre - Redefining Healthy Aging

Peterborough, Ontario, Canada

Toronto Memory Program (Neurology Research Inc.)

Toronto, Ontario, Canada

Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais

Gatineau, Quebec, Canada

MoCA Clinic and Institute/NeuroSearch Developpements Inc.

Greenfield Park, Quebec, Canada

Q&T Research Sherbrooke Inc.

Sherbrooke, Quebec, Canada

Beijing Friendship Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Xuanwu Hospital Capital Medical University

Beijing, Beijing Municipality, China

Beijing Tiantan Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

Guangzhou Huiai Hospital

Guangzhou, Guangdong, China

Guangdong Provincial People's Hospital

Guangzhou, Guangzhou, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Xiangya Hospital Central South University

Changsha, Hunan, China

Baotou Central Hospital

Baotou, Inner Mongolia, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Nanjing Brain Hospital, Affiliated to Nanjing Medical University

Nanjing, Jiangsu, China

The First Bethune Hospital of Jilin University

Changchun, Jilin, China

Qinghai Provincial People's Hospital

Xining, Qinghai, China

Jinan Central Hospital

Jinan, Shandong, China

Shanghai Tongji Hospital

Shanghai, Shanghai Municipality, China

Renji Hospital Shanghai Jiaotong Universtiy School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, China

Tianjin Huanhu Hospital

Tianjin, Tianjin Municipality, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Hopital de la Timone

Marseille, Cedex 05, France

Hôpital Gui de Chauliac

Montpellier, Cedex 5, France

Hopital Guillaume et Renà LaÃnnec

Nantes, Cedex, France

Groupe Hospitalier Pitie-Salpetriere

Paris, Cedex, France

Centre de Recherche Clinique du Gérontopôle

Toulouse, Haute Garonne, France

Centre de Neurologie Cognitive du Pr Paquet

Paris, Paris, France

Hôpital neurologique Pierre Wertheimer

Bron, France

Hôpitaux Universitaire de Strasbourg

Strasbourg, France

Bezirkskrankenhaus Guenzburg

Guenzburg, Baden-Wurttemberg, Germany

Central Institute o Mental Health - Department of Psychaitry

Mannheim, Baden-Wurttemberg, Germany

Klinik und Hochschulambulanz für Psychiatrie und Psychotherapie, Charité Universitätsmedizin Berlin, Gedächtnissprechstunde am ECRC

Berlin, Germany

Neurozentrum Bielefeld Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische

Bielefeld, Germany

Neuro Centrum Science GmbH

Erbach im Odenwald, Germany

TU Munchen

München, Germany

Ospedale "Card. G. Panico" -

Tricase, Lecce, Italy

Fondazione Istituto G.Giglio di Cefalù

Cefalù, Palermo, Italy

Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova

Genova, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative

Milan, Italy

IRCCS San Gerado dei Tintori

Monza, Italy

Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"

Naples, Italy

Ospedale S. Maria della Misericordia, S. Andrea delle Fratte

Perugia, Italy

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Fondazione Policlinico Agostino Gemelli - UCSC

Roma, Italy

Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane

Roma, Italy

National Center for Geriatrics and Gerontology

Obu-shi, Aichi-ken, Japan

Kashiwado hospital

Chiba, Chiba, Japan

University of Fukui Hospital

Eiheiji-cho, Yoshida-gun, Fukui, Japan

Shinozuka Hospital

Fujioka-shi, Gunma, Japan

National Hospital Organizaton Hiroshima-Nishi Medical Center

Ōtake, Hiroshima, Japan

Sapporo Teishinkai Hospital

Sapporo, Hokkaido, Japan

Hyogo Prefectural HarimaHimeji General Medical Center

Himeji-shi, Hyōgo, Japan

Kobe University Hospital

Kobe, Hyōgo, Japan

Memory clinic Toride

Toride-shi, Ibaraki, Japan

Kanazawa Medical University Hospital

Kahoku, Ishikawa-ken, Japan

Shonan Atsugi Hospital

Atsugi-shi, Kanagawa, Japan

Kawashima Neurology Clinic

Fujisawa-shi, Kanagawa, Japan

Nippon Medical School Musashi Kosugi Hospital

Kawasaki-shi, Kanagawa, Japan

Yokohama Brain and Spine Center

Yokohama, Kanagawa, Japan

Keimei Memorial Hospital

Higashimorokatagun, Miyazaki, Japan

General Rehabilitation Center Midori Hospital

Niigata, Niigata, Japan

Katayama Medical Clinic

Kurashiki-shi, Okayama-ken, Japan

Hatsuta Neurology Clinic

Hirakata, Osaka, Japan

Osaka University Hospital

Suita-shi, Osaka, Japan

Saitama Neuropsychiatric Institute

Saitama-shi, Saitama, Japan

Shiga University of Medical Science Hospital

Ōtsu, Shiga, Japan

Memory clinic Ochanomizu

Bunkyo-ku, Tokyo, Japan

The University of Tokyo Hospital

Bunkyo-ku, Tokyo, Japan

Tokyo Medical University Hachioji Medeical Center

Hachioji-shi, Tokyo, Japan

Japanese Red Cross Musashino Hospital

Musashino-shi, Tokyo, Japan

Showa University Hospital East Branch

Shinagawa-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Keio University Hospital

Shinjuku-ku, Tokyo, Japan

Yamagata Tokushukai Hospital

Yamagata, Yamagata, Japan

Nagamitsu Clinic

Hōfu, Yamaguchi, Japan

Yamaguchi University Hospital

Ube-shi, Yamaguchi, Japan

Osaka City University Hospital

Osaka, Japan

Tominaga Hospital

Osaka, Japan

First Moscow State Medical University n.a. I.M. Sechenov

Moscow, Russia

National University Hospital

Singapore, Singapore

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Chonnam National University Hospital

Gwangju, Jeolla-do, South Korea

Seoul National University Bundang Hospital

Seongnam-si, Seoul, South Korea

Dong-A University Hospital

Busan, South Korea

Inha University Hospital

Incheon, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Hanyang University Seoul Hospital

Seoul, South Korea

Konkuk University Medical Center

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul ST. Mary's Hospital

Seoul, South Korea

Seoul National University Boramae Medical Center

Seoul, South Korea

Hospital General de Catalunya

Sant Cugat del Vallès, Barcelona, Spain

Centro CAE Oroitu

Getxo, Bizkaia, Spain

Fundación CITA-alzheimer Findazioa

Donostia / San Sebastian, Gipuzkoa, Spain

Policlinica Guipuzcoa

Donostia / San Sebastian, Guipuzcoa, Spain

Hospital Santa Cruz y San Pablo

Barcelona, Spain

Fundacion ACE, Barcelona

Barcelona, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital Universitario Reina Sofía

Córdoba, Spain

Complejo Hospitalario Ruber Juan Bravo

Madrid, Spain

Hospital de Salamanca

Salamanca, Spain

Hospital Victoria Eugenia - Cruz Roja

Seville, Spain

Hospital Universitari i Politècnic La Fe

Valencia, Spain

Psykiatri kognition och äldrepsykiatri

Gothenburg, Västra Götalandslän, Sweden

Skånes universitetssjukhus

Malmö, Sweden

Karolinska University Hospital

Stockholm, Sweden

Uppsala University Hospital, Uppsala

Uppsala, Sweden

Re:Cognition Health

Plymouth, Devon, United Kingdom

Memory Assessment & Research Centre (MARC),

Southampton, Hampshire, United Kingdom

Sheffield Memory Service

Sheffield, South Yorkshire, United Kingdom

Re:Cognition Health Ltd

Birmingham, United Kingdom

Re:Cognition Health Ltd

Guildford, United Kingdom

St. Pancras Clinical Research

London, United Kingdom

Re:Cognition Health Ltd

London, United Kingdom

Charing Cross Hospital

London, United Kingdom