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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,906

Participants

Timeline

Start Date

March 27, 2019

Primary Completion Date

June 30, 2029

Study Completion Date

June 30, 2029

Conditions
Early Alzheimer's Disease
Interventions
DRUG

Lecanemab IV

Administered as IV infusion.

DRUG

Placebo

Biweekly (once every 2 weeks) administered as intravenous infusion.

DRUG

Lecanemab SC

Administered weekly as a subcutaneous injection.

Trial Locations (247)

2010

St Vincent's Hospital - Translational Research Centre, Darlinghurst

2229

KaRa Institute of Neurological Diseases, Macquarie Park

3081

Austin Health - Medical and Cognitive Research Unit, Ivanhoe

3144

HammondCare Malvern Clinical Trials Unit, Malvern

4032

The Prince Charles Hospital/Internal Medicine & Dementia Research Unit, Chermside Brisbane

5011

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

6009

Australian Alzheimer's Research Foundation, Nedlands

8025

Hospital Santa Cruz y San Pablo, Barcelona

10016

New York University Medical Center PRIME, New York

10032

Neurological Institute of New York, New York

12203

Eisai Trial Site #6, Berlin

12208

Albany Medical College, Albany

Neurological Associates of Albany, PC, Albany

13385

Hopital de la Timone, Marseille

13620

Seoul National University Bundang Hospital, Seongnam-si

Seoul National University Bundang Hospital, Seongnam-si

14011

Hospital Universitario Reina Sofía, Córdoba

14620

University of Rochester, Rochester

16132

Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova, Genova

19104

University of Pennsylvania, Philadelphia

19403

Keystone Clinical Studies, LLC, Norristown

20009

Fundación CITA-alzheimer Findazioa, Donostia / San Sebastian

20014

Policlinica Guipuzcoa, Donostia / San Sebastian

20057

Georgetown University Hospital, Washington D.C.

20122

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

20502

Memory Clinic, Malmö University Hospital, Malmo

20900

ASST-Monza, Ospedale San Gerardo, Monza

22332

Inha University Hospital, Incheon

23294

National Clinical Research Inc.-Richmond, Richmond

27103

PMG Research of Winston Salem, Winston-Salem

27607

Raleigh Neurology Associates, P.A. - Research Department, Raleigh

28006

Complejo Hospitalario Ruber Juan Bravo, Madrid

28270

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

29406

Roper St. Francis Healthcare, North Charleston

29935

Coastal Neurology, P.A., Port Royal

30030

iResearch Atlanta, LLC, Decatur

30033

NeuroStudies.net, LLC, Decatur

30329

Emory University Cognitive Neurology Clinic & ADRC, Atlanta

31059

Centre de Recherche Clinique du Gérontopôle, Toulouse

31909

Columbus Memory Center, Columbus

32127

Progressive Medical Research, Port Orange

32159

Charter Research, Lady Lake

32162

Bioclinica Research, The Villages

32174

Neurology Associates of Ormond Beach, Ormond Beach

32751

Clincloud, LLC, Maitland

32806

Bioclinica Research, Orlando

33016

Galiz Research, Miami Springs

33024

Infinity Clinical Research, Hollywood

33064

Quantum Laboratories Inc., Pompano Beach

33125

Gonzalez MD & Aswad MD Health Services, Miami

33126

BioMed Research Institute, Miami

Finlay Medical Research, Miami

33133

CCM Clinical Research Group, Miami

33134

Advanced Clinical Research Network, Coral Gables

Linfritz Research Institute, Inc., Coral Gables

33135

Rios Medical Center, Inc., Miami

Vitae Research Center, Miami

33137

Miami Jewish Health Systems, Miami

Visionary Investigators Network, Miami

33155

Allied Biomedical Research (Clinical Trial), Miami

33157

IMIC, Inc., Palmetto Bay

33175

Pharmax Research of South Florida, Inc, Miami

33180

Visionary Investigators Network, Miami

33351

Infinity Clinical Research, LLC, Sunrise

33407

Premiere Research Institute, West Palm, West Palm Beach

33410

Advanced Research Consultants, Inc., Palm Beach Gardens

33445

Brain Matters Research, Delray Beach

33449

Alzheimer's Research and Treatment Center, Lake Worth

33462

JEM Research Institute, Atlantis

33613

Stedman Clinical Trials, LLC, Tampa

USF Suncoast Gerontology Center, Tampa

33647

Eisai Trial Site #1, Bielefeld

33912

Neuropsychiatric Research Center of Southwest FL, Fort Myers

33952

Neurostudies, Inc., Port Charlotte

34205

Bradenton Research Center, Inc., Bradenton

34295

Hôpital Gui de Chauliac, Montpellier

34470

Renstar Medical Research, Ocala

34997

Alzheimer's Research and Treatment Center, Stuart

37005

Hospital de Salamanca, Salamanca

37920

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

38018

Neurology Clinic, P.C., Cordova

39401

Hattiesburg Clinic, Hattiesburg

41009

Hospital Victoria Eugenia - Cruz Roja, Seville

43020

Columbs Neuroscience, LLC, Columbus

43141

Sahlgrenska University Hospital, Gothenburg

43221

Ohio State University, Columbus

44093

Hopital Guillaume et Renà LaÃnnec, Nantes

44195

Cleveland Clinic, Cleveland

44718

OH Clinical Research Partners, Canton

46026

Hospital Universitari i Politècnic La Fe, Valencia

46202

Indiana University School of Medicine, Indianapolis

46804

Fort Wayne Neurological Center, Fort Wayne

48993

Centro CAE Oroitu, Getxo

49201

Dong-A University Hospital, Busan

50000

The Second Hospital of Hebei Medical University, Shijiazhuang

56126

Azienda Ospedaliero Universitaria Pisana, Pisa

60068

Advocate Lutheran General Hospital, Park Ridge

60640

Great Lakes Clinical Trials, Chicago

61469

Chonnam National University Hospital, Gwangju

63108

Washington University, St Louis

64711

Eisai Trial Site #4, Erbach im Odenwald

66160

University of Kansas Medical Center Research Institute, Kansas City

67200

Hôpital de Hautepierre, Strasbourg

67214

KU Wichita Center for Clinical Research, Wichita

69500

Hôpital neurologique Pierre Wertheimer, Bron

73039

"Ospedale Card. G. Panico -", Tricase

73112

Lynn Health Science Institute, Oklahoma City

75010

Hôpital Lariboisière, Paris

75013

Groupe Hospitalier Pitie-Salpetriere, Paris

75214

Texas Neurology, PA, Dallas

75231

Kerwin Research Center, Dallas

77030

Baylor College of Medicine AD and Memory Disorders Center, Houston

77074

Clinical Trial Network, Houston

78757

Senior Adult Specialty Research, Austin

80112

ImmunoE Research Center, Centennial

80138

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

80218

Mile High Research Center, Denver

81675

Eisai Trial Site #3, München

85006

Banner Alzheimer's Institute- Clinical Trials Department, Phoenix

85351

Banner Sun Health Research, Sun City

85718

Neurological Associates of Tucson dba Center for Neurosciences, Tucson

89106

Cleveland Clinic Lou Ruvo Center for Brain Health, Las Vegas

89113

Las Vegas Medical Research, Las Vegas

89312

Eisai Trial Site #5, Günzburg

90015

Fondazione Istituto G.Giglio di Cefalù, Cefalù

90045

University of California - Los Angeles, Los Angeles

92103

Pacific Research Network, Inc, San Diego

92123

Sharp Mesa Vista Hospital, San Diego

92614

Irvine Clinical Research, Irvine

92705

Apex Research Institute, Santa Ana

92835

Neurology Center of North Orange County, Fullerton

93030

Pacific Neuroscience Medical Group, Oxnard

94158

UCSF Memory and Aging Center, San Francisco

94304

Stanford University Medical Center, Palo Alto

95403

St Joseph Heritage Healthcare, Santa Rosa

95472

North Bay Neuroscience Research Institute, Sebastopol

96817

Hawaii Pacific Neuroscience, Honolulu

97210

Summit Research Network (OR) Inc., Portland

97225

Neural Net Research, LLC, Portland

97239

Oregon Health & Science University, Portland

99202

Kingfisher Cooperative LLC, Spokane

100050

Beijing Friendship Hospital, Capital Medical University, Beijing

100053

Xuanwu Hospital Capital Medical University, Beijing

100070

Beijing Tiantan Hospital, Capital Medical University, Beijing

119228

National University Hospital, Singapore

119991

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

130000

The First Bethune Hospital of Jilin University, Changchun

200065

Shanghai Tongji Hospital, Shanghai

200215

Renji Hospital Shanghai Jiaotong Universtiy School of Medicine, Shanghai

200233

Shanghai Sixth People's Hospital, Shanghai

210008

Nanjing Drum Tower Hospital, Nanjing

210029

Nanjing Brain Hospital, Affiliated to Nanjing Medical University, Nanjing

250013

Jinan Central Hospital, Jinan

300350

Tianjin Huanhu Hospital, Tianjin

310016

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

410008

Xiangya Hospital Central South University, Changsha

450003

Henan Provincial People's Hospital, Zhengzhou

510080

Guangdong Provincial People's Hospital, Guangzhou

510120

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

510180

Guangzhou First People's Hospital, Guangzhou

510450

Guangzhou Huiai Hospital, Guangzhou

650033

Eisai Trial Site #30, Sapporo

810007

Qinghai Provincial People's Hospital, Xining

2118533

Eisai Trial Site #20, Kawasaki-shi

2350012

Eisai Trial Site #2, Yokohama

2438551

Eisai Trial Site #7, Atsugi-shi

2510038

Eisai Trial Site #17, Fujisawa-shi

3750017

Eisai Trial Site #1, Fujioka-shi

4748511

Eisai Trial Site #4, Obu-shi

5458586

Eisai Trial Site #11, Osaka

5560017

Eisai Trial Site #27, Osaka

5731121

Eisai Trial Site #8, Hirakata

6500017

Eisai Trial Site #19, Kobe

6700981

Eisai Trial Site #28, Himeji-shi

7100813

Eisai Trial Site #16, Kurashiki-shi

7390696

Eisai Trial Site #32, Ōtake

7470802

Eisai Trial Site #21, Hōfu

9101193

Eisai Trial Site #6, Yoshida-gun

9500983

Eisai Trial Site #22, Niigata

9900834

Eisai Trial Site #3, Yamagata

06824

Associated Neurologists of Southern Connecticut, Fairfield

06510

Institute for Neurodegenerative Disorders, New Haven

Yale University School Of Medicine, New Haven

06851

Research Center for Clinical Studies, Inc., Norwalk

02478

Partners Population Health, Belmont

02115

Brigham and Women's Hospital, Boston

01844

ActivMed Practices & Research, Methuen

02459

Boston Center for Memory, Newton

02360

Donald S. Marks, MD. P.C., Plymouth

08755

Advanced Memory Research Institute of NJ, PC, Toms River

Bio Behavioral Health, Toms River

02914

Rhode Island Mood & Memory Research Institute, East Providence

02903

Rhode Island Hospital, Providence

02906

Butler Hospital - Memory and Aging Program, Providence

05201

DBA The Memory Clinic, Bennington

V1Y 1Z9

Okanagan Clinical Trials, Kelowna

V7T 1C5

Health Research, West Vancouver

B3S 1M7

True North Clinical Research Halifax, Inc., Halifax

B4N 4K9

True North Clinical Research Kentville, Inc., Kentville

N6C 0A7

St. Joseph's HC- Parkwood Institute, London

K1Z 1G3

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

K9H 2P4

Kawartha Centre - Redefining Healthy Aging, Peterborough

M3B 2S7

Toronto Memory Program (Neurology Research Inc.), Toronto

J8T 8JI

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

J4V 2J2

MoCA Clinic and Institute/NeuroSearch Developpements Inc., Greenfield Park

J1J 2G2

Q&T Research Sherbrooke Inc., Sherbrooke

014040

Baotou Central Hospital, Baotou

D-68159

Eisai Trial Site #2, Mannheim

06132

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

00168

Fondazione Policlinico Agostino Gemelli - UCSC, Roma

00185

Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane, Roma

260-8656

Eisai Trial Site #15, Chiba

302-0004

Eisai Trial Site #24, Toride-shi

920-0293

Eisai Trial Site #9, Kahoku

880-1111

Eisai Trial Site #33, Higashimorokatagun

565-0871

Eisai Trial Site #26, Suita-shi

338-8577

Eisai Trial Site #18, Saitama-shi

520-2192

Eisai Trial Site #31, Ōtsu

113-0034

Eisai Trial Site #5, Bunkyo-ku

180-8610

Eisai Trial Site #29, Bunkyo-ku

Eisai Trial Site #12, Musashino-shi

193-0998

Eisai Trial Site #13, Hachioji-shi

142-0054

Eisai Trial Site #23, Shinagawa-ku

160-0023

Eisai Trial Site #25, Shinjuku-ku

160-8582

Eisai Trial Site #10, Shinjuku-ku

755-8505

Eisai Trial Site #14, Ube-shi

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

04763

Hanyang University Seoul Hospital, Seoul

05030

Konkuk University Medical Center, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

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

07061

Seoul National University Boramae Medical Center, Seoul

08195

Hospital General de Catalunya, Sant Cugat del Vallès

08028

Fundacion ACE, Barcelona, Barcelona

08036

Hospital Clinic i Provincial de Barcelona, Barcelona

141 86

Karolinska University Hospital, Stockholm

751 85

Uppsala University Hospital, Uppsala, Uppsala

PL6 8BT

Re:Cognition Health, Plymouth

SO30 3JB

Memory Assessment & Research Centre (MARC),, Southampton

S5 7JT

Sheffield Memory Service, Sheffield

B16 8LT

Re:Cognition Health Ltd, Birmingham

GU2 7YD

Re:Cognition Health Ltd, Guildford

EC2Y 8 EA

St. Pancras Clinical Research, London

W1G 9JF

Re:Cognition Health Ltd, London

W6 8RF

Charing Cross Hospital, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Biogen

INDUSTRY

lead

Eisai Inc.

INDUSTRY