AzTrials
AzTrials

Early Alzheimer's DiseasePhase 3Clarity ADNCT03887455

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

A Phase 3 study testing Lecanemab IV and Lecanemab SC in people with Early Alzheimer's Disease, run by Eisai Inc. at 247 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Early Alzheimer's Disease
What is being tested?
Lecanemab IV and Lecanemab SC
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,906 participants
Where
247 sitesin 14 countries
Study dates
27 Mar 2019to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's Alzheimer's disease
  • History of transient ischemic attacks (TIA), stroke, or seizures within 12 months of Screening
  • Any psychiatric diagnosis or symptoms (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
  • Geriatric Depression Scale (GDS) score >=8 at Screening
  • Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example in skull and cardiac devices other than those approved as safe for use in MRI scanners)
  • Evidence of other clinically significant lesions on brain MRI at Screening that could indicate a dementia diagnosis other than Alzheimer's disease
Show all 29Show fewer
  • Other significant pathological findings on brain MRI at screening, including but not limited to: more than 4 microhemorrhages (defined as 10 millimeter [mm] or less at the greatest diameter); a single macrohemorrhage >10 mm at greatest diameter; an area of superficial siderosis; evidence of vasogenic edema; evidence of cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors (however, lesions diagnosed as meningiomas or arachnoid cysts and <1 centimeter [cm] at their greatest diameter need not be exclusionary)
  • Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
  • Participants with a bleeding disorder that is not under adequate control (including a platelet count <50,000 or international normalized ratio [INR] >1.5 for participants who are not on anticoagulant treatment, example, warfarin). Participants who are on anticoagulant therapy should have their anticoagulant status optimized and be on a stable dose for 4 weeks before Screening. Participants who are on anticoagulant therapy are not permitted to participate in cerebrospinal fluid (CSF) assessments
  • Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Participation in a clinical study involving any therapeutic monoclonal antibody, protein derived from a monoclonal antibody, immunoglobulin therapy, or vaccine within 6 months before screening unless it can be documented that the participant was randomized to placebo
  • Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapies and any β-site amyloid precursor protein cleaving enzyme [BACE] inhibitor therapies) unless it can be documented that the participant only received placebo
  • Participants who have any known prior exposure to lecanemab
  • Participants who were dosed in a clinical study involving any new chemical entities for AD within 6 months prior to screening unless it can be documented that the participant was in a placebo treatment arm
  • Extension Phase: Exclusion Criteria
  • Participants who discontinued early from the Core Study
  • Participants who develop the following conditions from the time of Screening for the Core Study to the start of the Extension Phase
  • Any neurological condition that may be contributing to cognitive impairment above and beyond that caused by the participant's AD
  • Any psychiatric diagnosis or symptoms, (example, hallucinations, major depression, or delusions) that could interfere with study procedures in the participant
  • Contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (example, in skull and cardiac devices other than those approved as safe for use in MRI scanners)
  • Other significant pathological findings on brain MRI during the Core Study including but not limited to: cerebral contusion, encephalomalacia, aneurysms, vascular malformations, or infective lesions; evidence of multiple lacunar infarcts or stroke involving a major vascular territory, severe small vessel, or white matter disease; space occupying lesions; or brain tumors will be exclusionary if based on the opinion of the investigator, with consultation of medical monitor, these findings may interfere with the study procedures or safety
  • Hypersensitivity to BAN2401 or any of the excipients, or to any monoclonal antibody treatment
  • Any immunological disease which is not adequately controlled, or which requires chronic treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives of monoclonal antibodies), systemic immunosuppressants, or plasmapheresis during the study
  • Any other clinically significant abnormalities in physical examination, vital signs, laboratory tests, or ECG, which in the opinion of the investigator require further investigation or treatment or which may interfere with study procedures or safety
  • Malignant neoplasms (except for basal or squamous cell carcinoma in situ of the skin, or localized prostate cancer in male participants) that are not stably and adequately controlled or which, based on the opinion of the investigator, may interfere with the participant's safety or participation in the study
  • Any other medical conditions (example, cardiac, respiratory, gastrointestinal, renal disease) which are not stably and adequately controlled, or which in the opinion of the investigator(s) could affect the participant's safety or interfere with the study assessments
  • Severe visual or hearing impairment that would prevent the participant from performing psychometric tests accurately
  • Extension Phase Part B: Exclusion Criteria
  • -In countries where lecanemab is authorized for use in APOE4 noncarriers and heterozygous carriers only, APOE4 homozygous carriers will not be eligible for participation in Extension Phase Part B. Any APOE4 homozygous carriers that are already participating in Extension Phase Part B in such countries will be discontinued from the study.

Trial locations and contacts

247 sites in 14 countries.

247 sites in 14 countries

United States112 sites

  • Albany Medical College

    Albany, New York, 12208

  • Neurological Associates of Albany, PC

    Albany, New York, 12208

  • Emory University Cognitive Neurology Clinic & ADRC

    Atlanta, Georgia, 30329

  • JEM Research Institute

    Atlantis, Florida, 33462

  • Senior Adult Specialty Research

    Austin, Texas, 78757

  • McLean Hospital

    Belmont, Massachusetts, 02478

  • DBA The Memory Clinic

    Bennington, Vermont, 05201

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Bradenton Research Center, Inc.

    Bradenton, Florida, 34205

  • NeuroScience Research Center LLC

    Canton, Ohio, 44718

  • ImmunoE Research Center

    Centennial, Colorado, 80112

  • Great Lakes Clinical Trials

    Chicago, Illinois, 60640

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Columbus Memory Center

    Columbus, Georgia, 31909

  • Columbs Neuroscience, LLC

    Columbus, Ohio, 43020

  • Ohio State University

    Columbus, Ohio, 43210

  • Linfritz Research Institute, Inc.

    Coral Gables, Florida, 33134

  • Neurology Clinic, P.C.

    Cordova, Tennessee, 38018

  • Texas Neurology, PA

    Dallas, Texas, 75206

  • Kerwin Research Center

    Dallas, Texas, 75231

  • iResearch Atlanta, LLC

    Decatur, Georgia, 30030

  • NeuroStudies.net, LLC

    Decatur, Georgia, 30030

  • Brain Matters Research

    Delray Beach, Florida, 33445

  • Mile High Research Center

    Denver, Colorado, 80218

  • Rhode Island Mood & Memory Research Institute

    East Providence, Rhode Island, 02914

  • Associated Neurologists of Southern Connecticut

    Fairfield, Connecticut, 06824

  • Neuropsychiatric Research Center of Southwest FL

    Fort Myers, Florida, 33912

  • Fort Wayne Neurological Center

    Fort Wayne, Indiana, 46804

  • Neurology Center of North Orange County

    Fullerton, California, 92835

  • Hattiesburg Clinic

    Hattiesburg, Mississippi, 39401

  • Infinity Clinical Research

    Hollywood, Florida, 33024

  • Hawaii Pacific Neuroscience

    Honolulu, Hawaii, 96817

  • Baylor College of Medicine AD and Memory Disorders Center

    Houston, Texas, 77030

  • Clinical Trial Network

    Houston, Texas, 77074

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • Irvine Clinical Research

    Irvine, California, 92614

  • University of Kansas Medical Center Research Institute

    Kansas City, Kansas, 66205

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

    Knoxville, Tennessee, 37920

  • Cleveland Clinic Lou Ruvo Center for Brain Health

    Las Vegas, Nevada, 89106

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40504

  • University of California - Los Angeles

    Los Angeles, California, 90045

  • Clincloud, LLC

    Maitland, Florida, 32751

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

    Matthews, North Carolina, 28105

  • ActivMed Practices & Research

    Methuen, Massachusetts, 01844

  • BioMed Research Institute

    Miami, Florida, 33126

  • Finlay Medical Research

    Miami, Florida, 33126

  • CCM Clinical Research Group

    Miami, Florida, 33133

  • Advance Medical Research Center

    Miami, Florida, 33135

  • Advanced Clinical Research Network

    Miami, Florida, 33135

  • Gonzalez MD & Aswad MD Health Services

    Miami, Florida, 33135

  • Vitae Research Center

    Miami, Florida, 33135

  • Miami Jewish Health Systems

    Miami, Florida, 33137

  • Allied Biomedical Research (Clinical Trial)

    Miami, Florida, 33155

  • Pharmax Research of South Florida, Inc

    Miami, Florida, 33175

  • IMIC, Inc.

    Miami, Florida, 33176

  • Visionary Investigators Network

    Miami, Florida, 33176

  • Visionary Investigators Network

    Miami, Florida, 33180

  • Galiz Research

    Miami Springs, Florida, 33016

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticut, 06510

  • Yale University School Of Medicine

    New Haven, Connecticut, 06510

  • New York University Medical Center PRIME

    New York, New York, 10016

  • Neurological Institute of New York

    New York, New York, 10032

  • Boston Center for Memory

    Newton, Massachusetts, 02459

  • Ralph H. Johnson VA Health Care System

    North Charleston, South Carolina, 29401

  • Research Center for Clinical Studies, Inc.

    Norwalk, Connecticut, 06851

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma, 73112

  • Synexus Clinical Research US, Inc.

    Orlando, Florida, 32806

  • Neurology Associates of Ormond Beach

    Ormond Beach, Florida, 32174

  • Pacific Neuroscience Medical Group

    Oxnard, California, 93030

  • Advanced Research Consultants, Inc.

    Palm Beach Gardens, Florida, 33410

  • Stanford University Medical Center

    Palo Alto, California, 94304

  • Advocate Lutheran General Hospital

    Park Ridge, Illinois, 60068

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Banner Alzheimer's Institute- Clinical Trials Department

    Phoenix, Arizona, 85006

  • Donald S. Marks, MD. P.C.

    Plymouth, Massachusetts, 02360

  • Keystone Clinical Studies, LLC

    Plymouth Meeting, Pennsylvania, 19462

  • Quantum Laboratories Inc.

    Pompano Beach, Florida, 33064

  • Neurostudies, Inc.

    Port Charlotte, Florida, 33952

  • Progressive Medical Research

    Port Orange, Florida, 32127

  • Coastal Neurology, P.A.

    Port Royal, South Carolina, 29935

  • Summit Research Network (OR) Inc.

    Portland, Oregon, 97210

  • Neural Net Research, LLC

    Portland, Oregon, 97225

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • Butler Hospital - Memory and Aging Program

    Providence, Rhode Island, 02906

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

    Raleigh, North Carolina, 27607

  • National Clinical Research Inc.-Richmond

    Richmond, Virginia, 23294

  • University of Rochester

    Rochester, New York, 14620

  • Pacific Research Network, Inc

    San Diego, California, 92103

  • Sharp Neurocognitive Research Center

    San Diego, California, 92123

  • UCSF Memory and Aging Center

    San Francisco, California, 94158

  • Apex Research Institute

    Santa Ana, California, 92705

  • St Joseph Heritage Healthcare

    Santa Rosa, California, 95403

  • Kingfisher Cooperative LLC

    Spokane, Washington, 99202

  • Washington University

    St Louis, Missouri, 63108

  • Alzheimer's Research and Treatment Center

    Stuart, Florida, 34996

  • Banner Sun Health Research

    Sun City, Arizona, 85351

  • Infinity Clinical Research, LLC

    Sunrise, Florida, 33351

  • Stedman Clinical Trials, LLC

    Tampa, Florida, 33613

  • USF Suncoast Gerontology Center

    Tampa, Florida, 33613

  • Charter Research

    The Villages, Florida, 32162

  • Synexus Clinical Research

    The Villages, Florida, 32162

  • Advanced Memory Research Institute of NJ, PC

    Toms River, New Jersey, 08755

  • Bio Behavioral Health

    Toms River, New Jersey, 08755

  • Neurological Associates of Tucson dba Center for Neurosciences

    Tucson, Arizona, 85718

  • Georgetown University Hospital

    Washington D.C., District of Columbia, 20057

  • Alzheimer's Research and Treatment Center

    Wellington, Florida, 33414

  • Premiere Research Institute, West Palm

    West Palm Beach, Florida, 33407

  • KU Wichita Center for Clinical Research

    Wichita, Kansas, 67214

  • PMG Research of Winston Salem

    Winston-Salem, North Carolina, 27103

Other trials in United States

Japan33 sites

  • Shonan Atsugi Hospital

    Atsugi-shi, Kanagawa, 2438551

  • Memory clinic Ochanomizu

    Bunkyo-ku, Tokyo, 113-0034

  • The University of Tokyo Hospital

    Bunkyo-ku, Tokyo, 180-8610

  • Kashiwado hospital

    Chiba, Chiba, 260-8656

  • University of Fukui Hospital

    Eiheiji-cho, Yoshida-gun, Fukui, 9101193

  • Shinozuka Hospital

    Fujioka-shi, Gunma, 3750017

  • Kawashima Neurology Clinic

    Fujisawa-shi, Kanagawa, 2510038

  • Tokyo Medical University Hachioji Medeical Center

    Hachioji-shi, Tokyo, 193-0998

  • Keimei Memorial Hospital

    Higashimorokatagun, Miyazaki, 880-1111

  • Hyogo Prefectural HarimaHimeji General Medical Center

    Himeji-shi, Hyōgo, 6708560

  • Hatsuta Neurology Clinic

    Hirakata, Osaka, 5731121

  • Nagamitsu Clinic

    Hōfu, Yamaguchi, 7470802

  • Kanazawa Medical University Hospital

    Kahoku, Ishikawa-ken, 920-0293

  • Nippon Medical School Musashi Kosugi Hospital

    Kawasaki-shi, Kanagawa, 2118533

  • Kobe University Hospital

    Kobe, Hyōgo, 6500017

  • Katayama Medical Clinic

    Kurashiki-shi, Okayama-ken, 7100813

  • Japanese Red Cross Musashino Hospital

    Musashino-shi, Tokyo, 180-8610

  • General Rehabilitation Center Midori Hospital

    Niigata, Niigata, 9500983

  • National Center for Geriatrics and Gerontology

    Obu-shi, Aichi-ken, 4748511

  • Osaka City University Hospital

    Osaka, 5458586

  • Tominaga Hospital

    Osaka, 5560017

  • National Hospital Organizaton Hiroshima-Nishi Medical Center

    Ōtake, Hiroshima, 7390696

  • Shiga University of Medical Science Hospital

    Ōtsu, Shiga, 520-2192

  • Saitama Neuropsychiatric Institute

    Saitama-shi, Saitama, 338-8577

  • Sapporo Teishinkai Hospital

    Sapporo, Hokkaido, 650033

  • Showa University Hospital East Branch

    Shinagawa-ku, Tokyo, 142-0054

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • Keio University Hospital

    Shinjuku-ku, Tokyo, 160-8582

  • Osaka University Hospital

    Suita-shi, Osaka, 565-0871

  • Memory clinic Toride

    Toride-shi, Ibaraki, 302-0004

  • Yamaguchi University Hospital

    Ube-shi, Yamaguchi, 755-8505

  • Yamagata Tokushukai Hospital

    Yamagata, Yamagata, 9900834

  • Yokohama Brain and Spine Center

    Yokohama, Kanagawa, 2350012

Other trials in Japan

China21 sites

  • Baotou Central Hospital

    Baotou, Inner Mongolia, 014040

  • Beijing Friendship Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100050

  • Xuanwu Hospital Capital Medical University

    Beijing, Beijing Municipality, 100053

  • Beijing Tiantan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100070

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin, 130000

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

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

    Guangzhou, Guangdong, 510120

  • Guangzhou First People's Hospital

    Guangzhou, Guangdong, 510180

  • Guangzhou Huiai Hospital

    Guangzhou, Guangdong, 510450

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangzhou, 510080

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

    Hangzhou, Zhejiang, 310016

  • Jinan Central Hospital

    Jinan, Shandong, 250013

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

  • Nanjing Brain Hospital, Affiliated to Nanjing Medical University

    Nanjing, Jiangsu, 210029

  • Shanghai Tongji Hospital

    Shanghai, Shanghai Municipality, 200065

  • Renji Hospital Shanghai Jiaotong Universtiy School of Medicine

    Shanghai, Shanghai Municipality, 200215

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality, 200233

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 50000

  • Tianjin Huanhu Hospital

    Tianjin, Tianjin Municipality, 300350

  • Qinghai Provincial People's Hospital

    Xining, Qinghai, 810007

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450003

Other trials in China

South Korea13 sites

  • Dong-A University Hospital

    Busan, 49201

  • Chonnam National University Hospital

    Gwangju, Jeolla-do, 61469

  • Inha University Hospital

    Incheon, 22332

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Seoul National University Bundang Hospital

    Seongnam-si, Seoul, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Hanyang University Seoul Hospital

    Seoul, 04763

  • Konkuk University Medical Center

    Seoul, 05030

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

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

    Seoul, 06591

  • Seoul National University Boramae Medical Center

    Seoul, 07061

Other trials in South Korea

Spain12 sites

  • Hospital Santa Cruz y San Pablo

    Barcelona, 08025

  • Fundacion ACE, Barcelona

    Barcelona, 08028

  • Hospital Clinic i Provincial de Barcelona

    Barcelona, 08036

  • Hospital Universitario Reina Sofía

    Córdoba, 14011

  • Fundación CITA-alzheimer Findazioa

    Donostia / San Sebastian, Gipuzkoa, 20009

  • Policlinica Guipuzcoa

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Centro CAE Oroitu

    Getxo, Bizkaia, 48993

  • Complejo Hospitalario Ruber Juan Bravo

    Madrid, 28006

  • Hospital de Salamanca

    Salamanca, 37005

  • Hospital General de Catalunya

    Sant Cugat del Vallès, Barcelona, 08195

  • Hospital Victoria Eugenia - Cruz Roja

    Seville, 41009

  • Hospital Universitari i Politècnic La Fe

    Valencia, 46026

Other trials in Spain

Canada11 sites

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

    Gatineau, Quebec, J8T 8JI

  • MoCA Clinic and Institute/NeuroSearch Developpements Inc.

    Greenfield Park, Quebec, J4V 2J2

  • Centricity Research Halifax

    Halifax, Nova Scotia, B3S 1N2

  • Okanagan Clinical Trials

    Kelowna, British Columbia, V1Y 1Z9

  • True North Clinical Research Kentville, Inc.

    Kentville, Nova Scotia, B4N 4K9

  • St. Joseph's HC- Parkwood Institute

    London, Ontario, N6C 0A7

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

    Ottawa, Ontario, K1Z 1G3

  • Kawartha Centre - Redefining Healthy Aging

    Peterborough, Ontario, K9H 2P4

  • Q&T Research Sherbrooke Inc.

    Sherbrooke, Quebec, J1J 2G2

  • Toronto Memory Program (Neurology Research Inc.)

    Toronto, Ontario, M3B 2S7

  • Health Research

    West Vancouver, British Columbia, V7T 1C5

Other trials in Canada

Italy10 sites

  • Fondazione Istituto G.Giglio di Cefalù

    Cefalù, Palermo, 90015

  • Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova

    Genova, 16132

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

    Milan, 20122

  • IRCCS San Gerado dei Tintori

    Monza, 20900

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

    Naples, 80138

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

    Perugia, 06132

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, 56126

  • Fondazione Policlinico Agostino Gemelli - UCSC

    Roma, 00168

  • Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane

    Roma, 00185

  • Ospedale "Card. G. Panico" -

    Tricase, Lecce, 73039

Other trials in Italy

France8 sites

  • Hôpital neurologique Pierre Wertheimer

    Bron, 69677

  • Hopital de la Timone

    Marseille, Cedex 05, 13385

  • Hôpital Gui de Chauliac

    Montpellier, Cedex 5, 34000

  • Hopital Guillaume et Renà LaÃnnec

    Nantes, Cedex, 44093

  • Groupe Hospitalier Pitie-Salpetriere

    Paris, Cedex, 75013

  • Centre de Neurologie Cognitive du Pr Paquet

    Paris, Paris, 75475

  • Hôpitaux Universitaire de Strasbourg

    Strasbourg, 67000

  • Centre de Recherche Clinique du Gérontopôle

    Toulouse, Haute Garonne, 31059

Other trials in France

United Kingdom8 sites

  • Re:Cognition Health Ltd

    Birmingham, B16 8LT

  • Re:Cognition Health Ltd

    Guildford, GU2 7YD

  • St. Pancras Clinical Research

    London, EC2Y 8 EA

  • Re:Cognition Health Ltd

    London, W1G 9JF

  • Charing Cross Hospital

    London, W6 8RF

  • Re:Cognition Health

    Plymouth, Devon, PL6 8BT

  • Sheffield Memory Service

    Sheffield, South Yorkshire, S5 7JT

  • Memory Assessment & Research Centre (MARC),

    Southampton, Hampshire, SO30 3JB

Other trials in United Kingdom

Australia7 sites

  • The Prince Charles Hospital/Internal Medicine & Dementia Research Unit

    Chermside Brisbane, Queensland, 4032

  • St Vincent's Hospital - Translational Research Centre

    Darlinghurst, New South Wales, 2010

  • Austin Health - Medical and Cognitive Research Unit

    Ivanhoe, Victoria, 3081

  • KaRa Institute of Neurological Diseases

    Macquarie Park, New South Wales, 2229

  • HammondCare Malvern Clinical Trials Unit

    Malvern, Victoria, 3144

  • Australian Alzheimer's Research Foundation

    Nedlands, Western Australia, 6009

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

    Woodville South, Adelaid, South Australia, 5011

Other trials in Australia

Germany6 sites

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

    Berlin, 13125

  • Neurozentrum Bielefeld Schwerpunktpraxis fuer Neurologie, Psychiatrie und Klinische

    Bielefeld, 33647

  • Neuro Centrum Science GmbH

    Erbach im Odenwald, 64711

  • Bezirkskrankenhaus Guenzburg

    Guenzburg, Baden-Wurttemberg, 89312

  • Central Institute o Mental Health - Department of Psychaitry

    Mannheim, Baden-Wurttemberg, D-68159

  • TU Munchen

    München, 81675

Other trials in Germany

Sweden4 sites

  • Psykiatri kognition och äldrepsykiatri

    Gothenburg, Västra Götalandslän, 43141

  • Skånes universitetssjukhus

    Malmö, 211 46

  • Karolinska University Hospital

    Stockholm, 141 86

  • Uppsala University Hospital, Uppsala

    Uppsala, 751 85

Other trials in Sweden

Russia1 site

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

    Moscow, 119435

Other trials in Russia

Singapore1 site

  • National University Hospital

    Singapore, 119228

Other trials in Singapore

About this study

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

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.

Read the detailed description

All administrations of study drug will be administered in the clinic or in the home; However, home administrations of intravenous (IV) study drug will be allowed per sponsor approval according to country and local guidelines during the COVID-19 pandemic and following its resolution, where permitted.

Being tested
Lecanemab IV, Placebo, Lecanemab SC
Keywords
BAN2401, Clinical Dementia Rating-Sum of Boxes, Mild cognitive impairment, Alzheimer's disease/prodromal Alzheimer's disease, Mild Alzheimer's disease dementia, Clarity AD, Lecanemab
Medical subject headings
Alzheimer Disease, Cognitive Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Lecanemab IVDrug

    Also called BAN2401

    Administered as IV infusion.

  • PlaceboDrug

    Biweekly (once every 2 weeks) administered as IVinfusion.

  • Lecanemab SCDrug

    Also called BAN2401

    Administered weekly as a SC injection.

Study groups in NCT03887455
Study groupRoleWhat they receive
Core Study: Lecanemab 10 milligram per kilogram (mg/kg) biweeklyExperimentalNot described
Receives: Drug: Lecanemab IV
Core Study: PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo
Extension Phase: Lecanemab 10 mg/kg biweeklyExperimentalNot described
Receives: Drug: Lecanemab IV
Extension Phase: Lecanemab Subcutaneous (SC) Injection Dose 1ExperimentalThis will include approximately 40 de novo participants (those that did not participate in the core study) with EAD.
Receives: Drug: Lecanemab SC
Extension Phase: Lecanemab SC Injection Dose 2ExperimentalNot described
Receives: Drug: Lecanemab SC
Extension Phase: Lecanemab SC Injection Dose 3ExperimentalNot described
Receives: Drug: Lecanemab SC
Extension Phase: Lecanemab SC Injection Dose 4ExperimentalNot described
Receives: Drug: Lecanemab SC
Extension Phase: Lecanemab 10 mg/kg IV Infusion Once Every 4 Weeks (Q4W)ExperimentalNot described
Receives: Drug: Lecanemab IV
Extension Phase BExperimentalParticipants will receive Lecanemab 10 mg/kg IV infusion Q2W, or Q4W, or Dose 3, or Dose 4, SC injection, weekly.
Receives: Drug: Lecanemab IV; Drug: Lecanemab SC

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Core Study: Change from Baseline in the CDR-SB at 18 Months

    Measured: Baseline, 18 months

  2. Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)

    A TEAE is defined as an adverse event (AE) that emerges during treatment or within 30 days of the last dose of study drug, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) will be reported based on their regular measurement of vital signs, safety assessments of laboratory tests, antidrug antibody assessments, suicidality assessments, magnetic resonance imaging and electrocardiogram parameter values.

    Measured: From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase

  3. Extension Phase: Change from Core Study Baseline in CDR-SB

    Measured: Baseline up to Month 66

  4. Extension Phase Part B: Number of Participants Exposed to Lecanemab

    Measured: From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)

Secondary outcomes (8)

  1. Core Study: Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at 18 Months

    Measured: Baseline, 18 months

  2. Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months

    Measured: Baseline, 18 months

  3. Core Study: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months

    Measured: Baseline, 18 months

  4. Core Study: Change From Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment (ADCS MCI-ADL) at 18 Months

    Measured: Baseline, 18 months

  5. Core Study: Number of Participants Reporting One or More TEAEs

    A TEAE is defined as an AE that emerges during treatment or within 30 days of the last dose of study drug, having been absent at pretreatment (Baseline) or reemerges during treatment, having been present at pretreatment (Baseline) but stopped before treatment, or worsens in severity during treatment relative to the pretreatment state, when the adverse event was continuous. Number of participants with TEAEs (serious and non-serious adverse events) will be reported based on their regular measurement of vital signs, safety assessments of laboratory tests, suicidality assessments, magnetic resonance imaging and electrocardiogram parameter values.

    Measured: From first dose of study drug up to approximately 21 months (including 3 months follow-up)

  6. Core Study: Area Under the Curve of Lecanemab in Serum

    Measured: Up to 21 months

  7. Core Study: Average Concentration (Cav) of Lecanemab in Serum

    Measured: Up to 21 months

  8. Extension Phase Part B: Number of Participants Reporting AEs

    Measured: From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2019
  2. Study start27 Mar 2019
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,906 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03887455
Sponsor's protocol ID
BAN2401-G000-301
Other IDs
2018-004739-58, 2024-510887-22, 2018
Acronym
Clarity AD
Status last verified
Mar 2026
First submitted
21 Mar 2019
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Publications

  • Boustani M, Klein EG, Zimmer JA, Wang H, Engle SE, Phipps A, Japha M, Schilling T, Hartry A; Alzheimer's Disease Neuroimaging Initiative. Further data to address the Alzheimer's coverage with evidence development questions. Alzheimers Dement. 2026 Aug;22(8):e71724. doi: 10.1002/alz.71724.

    PubMed 42552749

  • Perry R, Kipps C, Soto Martin ME, Bozzali M, Logroscino G, Trafford S, Dhadda S, Kanekiyo M, Goodwin A, Hodgkinson M, Hersch S, Irizarry M, Kramer L, Froelich L. Lecanemab for treatment of individuals with early Alzheimer's Disease (AD) who are apolipoprotein E epsilon4 (ApoE epsilon4) non-carriers or heterozygotes. J Prev Alzheimers Dis. 2026 Apr;13(4):100507. doi: 10.1016/j.tjpad.2026.100507. Epub 2026 Feb 13.

    PubMed 41689888

  • Devanarayan V, Horie K, Wildsmith K, Doherty T, Andreozzi E, Charil A, Sachdev P, Kramer LD, Dhadda S, Irizarry MC. Combining CSF MTBR-tau243 and plasma pTau217 ratio enhances the prediction of continuous regional tau PET burden in early Alzheimer's disease. Alzheimers Dement. 2025 Nov;21(11):e70881. doi: 10.1002/alz.70881.

    PubMed 41170658

  • Devanarayan V, Ye Y, Zhu L, Tian L, Kramer L, Irizarry M, Dhadda S. Predicted natural progression as an Alzheimer's prognostic covariate improves the precision of lecanemab efficacy assessments and clinical trial efficiency. Alzheimers Dement. 2025 Mar;21(3):e70045. doi: 10.1002/alz.70045.

    PubMed 40042496

  • Devanarayan V, Charil A, Horie K, Doherty T, Llano DA, Andreozzi E, Sachdev P, Ye Y, Murali LK, Zhou J, Reyderman L, Hampel H, Kramer LD, Dhadda S, Irizarry MC; Alzheimer's Disease Neuroimaging Initiative (ADNI). Plasma pTau217 ratio predicts continuous regional brain tau accumulation in amyloid-positive early Alzheimer's disease. Alzheimers Dement. 2025 Feb;21(2):e14411. doi: 10.1002/alz.14411. Epub 2024 Nov 22.

    PubMed 39575854

  • Devanarayan V, Doherty T, Charil A, Sachdev P, Ye Y, Murali LK, Llano DA, Zhou J, Reyderman L, Hampel H, Kramer LD, Dhadda S, Irizarry MC. Plasma pTau217 predicts continuous brain amyloid levels in preclinical and early Alzheimer's disease. Alzheimers Dement. 2024 Aug;20(8):5617-5628. doi: 10.1002/alz.14073. Epub 2024 Jun 28.

    PubMed 38940656

  • Honig LS, Sabbagh MN, van Dyck CH, Sperling RA, Hersch S, Matta A, Giorgi L, Gee M, Kanekiyo M, Li D, Purcell D, Dhadda S, Irizarry M, Kramer L. Updated safety results from phase 3 lecanemab study in early Alzheimer's disease. Alzheimers Res Ther. 2024 May 10;16(1):105. doi: 10.1186/s13195-024-01441-8.

    PubMed 38730496

  • Tahami Monfared AA, Ye W, Sardesai A, Folse H, Chavan A, Aruffo E, Zhang Q. A Path to Improved Alzheimer's Care: Simulating Long-Term Health Outcomes of Lecanemab in Early Alzheimer's Disease from the CLARITY AD Trial. Neurol Ther. 2023 Jun;12(3):863-881. doi: 10.1007/s40120-023-00473-w. Epub 2023 Apr 2.

    PubMed 37009976

  • van Dyck CH, Swanson CJ, Aisen P, Bateman RJ, Chen C, Gee M, Kanekiyo M, Li D, Reyderman L, Cohen S, Froelich L, Katayama S, Sabbagh M, Vellas B, Watson D, Dhadda S, Irizarry M, Kramer LD, Iwatsubo T. Lecanemab in Early Alzheimer's Disease. N Engl J Med. 2023 Jan 5;388(1):9-21. doi: 10.1056/NEJMoa2212948. Epub 2022 Nov 29.

    PubMed 36449413

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lecanemab IV and Lecanemab SC in people with Early Alzheimer's Disease, run by Eisai Inc. at 247 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 247 sites in United States, Japan, China, South Korea, Spain and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Core Study: Change from Baseline in the CDR-SB at 18 Months (time frame: Baseline, 18 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03887455, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.

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