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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

2029-06-30

Last Updated

2026-04-07

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 Mesa Vista Hospital

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

North Bay Neuroscience Research Institute

Sebastopol, 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

Advanced Clinical Research Network

Coral Gables, 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

Charter Research

Lady Lake, Florida, United States

Alzheimer's Research and Treatment Center

Lake Worth, Florida, United States

Clincloud, LLC

Maitland, Florida, United States

Gonzalez MD & Aswad MD Health Services

Miami, 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

Rios Medical Center, Inc.

Miami, Florida, United States

Vitae Research Center

Miami, Florida, United States

Miami Jewish Health Systems

Miami, Florida, United States

Visionary Investigators Network

Miami, Florida, United States

Allied Biomedical Research (Clinical Trial)

Miami, Florida, United States

Pharmax Research of South Florida, Inc

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

Bioclinica Research

Orlando, Florida, United States

Neurology Associates of Ormond Beach

Ormond Beach, Florida, United States

Advanced Research Consultants, Inc.

Palm Beach Gardens, Florida, United States

IMIC, Inc.

Palmetto Bay, 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

Bioclinica Research

The Villages, 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

Partners Population Health

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

Charlotte, 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

OH Clinical Research Partners

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

Keystone Clinical Studies, LLC

Norristown, Pennsylvania, United States

University of Pennsylvania

Philadelphia, 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

Roper St. Francis Healthcare

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

True North Clinical Research Halifax, Inc.

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

Hôpital de Hautepierre

Strasbourg, Bas Rhin, France

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

Hôpital Lariboisière

Paris, Paris, France

Hôpital neurologique Pierre Wertheimer

Bron, France

Eisai Trial Site #5

Günzburg, Baden-Wurttemberg, Germany

Eisai Trial Site #2

Mannheim, Baden-Wurttemberg, Germany

Eisai Trial Site #6

Berlin, Germany

Eisai Trial Site #1

Bielefeld, Germany

Eisai Trial Site #4

Erbach im Odenwald, Germany

Eisai Trial Site #3

München, Germany

Ospedale "Card. G. Panico" -

Tricase, LE, 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

ASST-Monza, Ospedale San Gerardo

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

Eisai Trial Site #4

Obu-shi, Aichi-ken, Japan

Eisai Trial Site #15

Chiba, Chiba, Japan

Eisai Trial Site #6

Yoshida-gun, Fukui, Japan

Eisai Trial Site #1

Fujioka-shi, Gunma, Japan

Eisai Trial Site #32

Ōtake, Hiroshima, Japan

Eisai Trial Site #30

Sapporo, Hokkaido, Japan

Eisai Trial Site #28

Himeji-shi, Hyōgo, Japan

Eisai Trial Site #19

Kobe, Hyōgo, Japan

Eisai Trial Site #24

Toride-shi, Ibaraki, Japan

Eisai Trial Site #9

Kahoku, Ishikawa-ken, Japan

Eisai Trial Site #7

Atsugi-shi, Kanagawa, Japan

Eisai Trial Site #17

Fujisawa-shi, Kanagawa, Japan

Eisai Trial Site #20

Kawasaki-shi, Kanagawa, Japan

Eisai Trial Site #2

Yokohama, Kanagawa, Japan

Eisai Trial Site #33

Higashimorokatagun, Miyazaki, Japan

Eisai Trial Site #22

Niigata, Niigata, Japan

Eisai Trial Site #16

Kurashiki-shi, Okayama-ken, Japan

Eisai Trial Site #8

Hirakata, Osaka, Japan

Eisai Trial Site #26

Suita-shi, Osaka, Japan

Eisai Trial Site #18

Saitama-shi, Saitama, Japan

Eisai Trial Site #31

Ōtsu, Shiga, Japan

Eisai Trial Site #5

Bunkyo-ku, Tokyo, Japan

Eisai Trial Site #29

Bunkyo-ku, Tokyo, Japan

Eisai Trial Site #13

Hachioji-shi, Tokyo, Japan

Eisai Trial Site #12

Musashino-shi, Tokyo, Japan

Eisai Trial Site #23

Shinagawa-ku, Tokyo, Japan

Eisai Trial Site #25

Shinjuku-ku, Tokyo, Japan

Eisai Trial Site #10

Shinjuku-ku, Tokyo, Japan

Eisai Trial Site #3

Yamagata, Yamagata, Japan

Eisai Trial Site #21

Hōfu, Yamaguchi, Japan

Eisai Trial Site #14

Ube-shi, Yamaguchi, Japan

Eisai Trial Site #11

Osaka, Japan

Eisai Trial Site #27

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

Fundacion ACE, Barcelona

Barcelona, Spain

Hospital Clinic i Provincial de Barcelona

Barcelona, Spain

Hospital Santa Cruz y San Pablo

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

Sahlgrenska University Hospital

Gothenburg, Västra Götalandslän, Sweden

Memory Clinic, Malmö University Hospital

Malmo, 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