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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Early Alzheimer's Disease
• Intervention / Treatment: Drug: Lecanemab; Drug: Lecanemab; Drug: Placebo

Detailed Description

All administrations of study drug will be administered in the clinic; However, home administrations of 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.

• Study Type: Interventional
• Enrollment (Actual): 1906
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital - Translational Research Centre
    • Macquarie Park, New South Wales, Australia, 2229
      • KaRa Institute of Neurological Diseases
  • Queensland
    • Chermside Brisbane, Queensland, Australia, 4032
      • The Prince Charles Hospital/Internal Medicine & Dementia Research Unit
  • South Australia
    • Woodville South, Adelaid, South Australia, Australia, 5011
      • Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital
  • Victoria
    • Ivanhoe, Victoria, Australia, 3081
      • Austin Health - Medical and Cognitive Research Unit
    • Malvern, Victoria, Australia, 3144
      • HammondCare Malvern Clinical Trials Unit
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Australian Alzheimer's Research Foundation
• Canada
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1Z9
      • Okanagan Clinical Trials
    • West Vancouver, British Columbia, Canada, V7T 1C5
      • Health Research
  • Nova Scotia
    • Halifax, Nova Scotia, Canada, B3S 1M7
      • True North Clinical Research Halifax, Inc.
    • Kentville, Nova Scotia, Canada, B4N 4K9
      • True North Clinical Research Kentville, Inc.
  • Ontario
    • London, Ontario, Canada, N6C 0A7
      • St. Joseph's HC- Parkwood Institute
    • Ottawa, Ontario, Canada, K1Z 1G3
      • Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic
    • Peterborough, Ontario, Canada, K9H 2P4
      • Kawartha Centre - Redefining Healthy Aging
    • Toronto, Ontario, Canada, M3B 2S7
      • Toronto Memory Program (Neurology Research Inc.)
  • Quebec
    • Gatineau, Quebec, Canada, J8T 8JI
      • Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • MoCA Clinic and Institute/NeuroSearch Developpements Inc.
    • Sherbrooke, Quebec, Canada, J1J 2G2
      • Q&T Research Sherbrooke Inc.
• China
  • Beijing
    • Beijing, Beijing, China, 100050
      • Beijing Friendship Hospital, Capital Medical University
    • Beijing, Beijing, China, 100053
      • Xuanwu Hospital Capital Medical University
    • Beijing, Beijing, China, 100070
      • Beijing Tiantan Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510180
      • Guangzhou First people's Hospital
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University
    • Guangzhou, Guangdong, China, 510450
      • Guangzhou Huiai Hospital
  • Guangzhou
    • Guangzhou, Guangzhou, China, 510080
      • Guangdong Provincial People's Hospital
  • Hebei
    • Shijiazhuang, Hebei, China, 50000
      • The Second Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China, 450003
      • Henan Provincial People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Inner Mongolia Autonomous Region
    • Baotou, Inner Mongolia Autonomous Region, China, 014040
      • Baotou Central Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China, 210008
      • Nanjing Drum Tower Hospital
    • Nanjing, Jiangsu, China, 210029
      • Nanjing Brain Hospital, Affiliated to Nanjing Medical University
  • Jilin
    • Changchun, Jilin, China, 130000
      • The First Bethune Hospital of Jilin University
  • Qinghai
    • Xining, Qinghai, China, 810007
      • Qinghai Provincial People's Hospital
  • Shandong
    • Jinan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200065
      • Shanghai Tongji Hospital
    • Shanghai, Shanghai, China, 200215
      • Renji Hospital Shanghai Jiaotong Universtiy School of Medicine
    • Shanghai, Shanghai, China, 200233
      • Shanghai Sixth People's Hospital
  • Tianjin
    • Tianjin, Tianjin, China, 300350
      • Tianjin Huanhu Hospital
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310016
      • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
• France
  • Bron Cedex, France, 69500
    • Hôpital Neurologique Pierre Wertheimer
  • Bas Rhin
    • Strasbourg Cedex, Bas Rhin, France, 67200
      • Hopital de Hautepierre
  • Cedex
    • Nantes, Cedex, France, 44093
      • Hopital Guillaume et Renà LaÃnnec
    • Paris, Cedex, France, 75013
      • Groupe Hospitalier Pitie-Salpetriere
  • Cedex 05
    • Marseille, Cedex 05, France, 13385
      • Hopital de la Timone
  • Cedex 5
    • Montpellier, Cedex 5, France, 34295
      • Hopital Gui de Chauliac
  • Haute Garonne
    • Toulouse, Haute Garonne, France, 31059
      • Centre de Recherche Clinique du Gérontopôle
  • Paris
    • Paris cedex 10, Paris, France, 75010
      • Hopital Lariboisiere
• Germany
  • Berlin, Germany, 12203
    • Eisai Trial Site #6
  • Bielefeld, Germany, 33647
    • Eisai Trial Site #1
  • Erbach, Germany, 64711
    • Eisai Trial Site #4
  • Munchen, Germany, 81675
    • Eisai Trial Site #3
  • Baden Wuerttemberg
    • Günzburg, Baden Wuerttemberg, Germany, 89312
      • Eisai Trial Site #5
  • Baden-Wurttemberg
    • Mannheim, Baden-Wurttemberg, Germany, D-68159
      • Eisai Trial Site #2
• Italy
  • Genova, Italy, 16132
    • Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova
  • Milano, Italy, 20122
    • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative
  • Monza, Italy, 20900
    • ASST-Monza, Ospedale San Gerardo
  • Napoli, Italy, 80138
    • Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"
  • Perugia, Italy, 06132
    • Ospedale S. Maria della Misericordia, S. Andrea delle Fratte
  • Pisa, Italy, 56126
    • Azienda Ospedaliero Universitaria Pisana
  • Roma, Italy, 00168
    • Fondazione Policlinico Agostino Gemelli - UCSC
  • Roma, Italy, 00185
    • Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane
  • LE
    • Tricase, LE, Italy, 73039
      • Ospedale "Card. G. Panico" -
  • Palermo
    • Cefalu, Palermo, Italy, 90015
      • Fondazione Istituto G.Giglio di Cefalù
• Japan
  • Osaka, Japan, 5458586
    • Eisai Trial Site #11
  • Osaka, Japan, 5560017
    • Eisai Trial Site #27
  • Aichi
    • Obu-shi, Aichi, Japan, 4748511
      • Eisai Trial Site #4
  • Chiba
    • Chiba-shi, Chiba, Japan, 260-8656
      • Eisai Trial Site #15
  • Fukui
    • Yoshida-gun, Fukui, Japan, 9101193
      • Eisai Trial Site #6
  • Gunma
    • Fujioka-shi, Gunma, Japan, 3750017
      • Eisai Trial Site #1
  • Hiroshima
    • Otake, Hiroshima, Japan, 7390696
      • Eisai Trial Site #32
  • Hokkaido
    • Sapporo-shi, Hokkaido, Japan, 650033
      • Eisai Trial Site #30
  • Hyogo
    • Himeji-shi, Hyogo, Japan, 6700981
      • Eisai Trial Site #28
    • Kobe-shi, Hyogo, Japan, 6500017
      • Eisai Trial Site #19
  • Ibaraki
    • Toride-shi, Ibaraki, Japan, 302-0004
      • Eisai Trial Site #24
  • Ishikawa
    • Kahoku, Ishikawa, Japan, 920-0293
      • Eisai Trial Site #9
  • Kanagawa
    • Atsugi-shi, Kanagawa, Japan, 2438551
      • Eisai Trial Site #7
    • Fujisawa-shi, Kanagawa, Japan, 2510038
      • Eisai Trial Site #17
    • Kawasaki-shi, Kanagawa, Japan, 2118533
      • Eisai Trial Site #20
    • Yokohama-shi, Kanagawa, Japan, 2350012
      • Eisai Trial Site #2
  • Miyazaki
    • Higashimorokatagun, Miyazaki, Japan, 880-1111
      • Eisai Trial Site #33
  • Niigata
    • Niigata-shi, Niigata, Japan, 9500983
      • Eisai Trial Site #22
  • Okayama
    • Kurashiki-shi, Okayama, Japan, 7100813
      • Eisai Trial Site #16
  • Osaka
    • Hirakata, Osaka, Japan, 5731121
      • Eisai Trial Site #8
    • Suita-shi, Osaka, Japan, 565-0871
      • Eisai Trial Site #26
  • Saitama
    • Saitama-shi, Saitama, Japan, 338-8577
      • Eisai Trial Site #18
  • Shiga
    • Otsu-shi, Shiga, Japan, 520-2192
      • Eisai Trial Site #31
  • Tokyo
    • Bunkyo-ku, Tokyo, Japan, 113-0034
      • Eisai Trial Site #5
    • Bunkyo-ku, Tokyo, Japan, 180-8610
      • Eisai Trial Site #29
    • Hachioji-shi, Tokyo, Japan, 193-0998
      • Eisai Trial Site #13
    • Musashino-shi, Tokyo, Japan, 180-8610
      • Eisai Trial Site #12
    • Shinagawa-ku, Tokyo, Japan, 142-0054
      • Eisai Trial Site #23
    • Shinjuku-ku, Tokyo, Japan, 160-0023
      • Eisai Trial Site #25
    • Shinjuku-ku, Tokyo, Japan, 160-8582
      • Eisai Trial Site #10
  • Yamagata
    • Yamagata-shi, Yamagata, Japan, 9900834
      • Eisai Trial Site #3
  • Yamaguchi
    • Hofu, Yamaguchi, Japan, 7470802
      • Eisai Trial Site #21
    • Ube-shi, Yamaguchi, Japan, 755-8505
      • Eisai Trial Site #14
• Korea, Republic of
  • Busan, Korea, Republic of, 49201
    • Dong-A University Hospital
  • Incheon, Korea, Republic of, 22332
    • Inha University Hospital
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital
  • Seoul, Korea, Republic of, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, Korea, Republic of, 05030
    • Konkuk University Medical Center
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 06591
    • The Catholic University of Korea, Seoul St. Mary's Hospital
  • Seoul, Korea, Republic of, 04763
    • Hanyang University Seoul Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
  • Seoul, Korea, Republic of, 07061
    • Seoul National University Boramae Medical Center
  • Gyeonggi-do
    • Seongnam, Gyeonggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
  • Jeolla-do
    • Gwangju, Jeolla-do, Korea, Republic of, 61469
      • Chonnam National University Hospital
  • Seoul
    • Seongnam-si, Seoul, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital
• Russian Federation
  • Moscow, Russian Federation, 119991
    • First Moscow State Medical University n.a. I.M. Sechenov
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital
• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08028
    • Fundacion ACE, Barcelona
  • Barcelona, Spain, 8025
    • Hospital Santa Cruz y San Pablo
  • Cordoba, Spain, 14011
    • Hospital Universitario Reina Sofia
  • Madrid, Spain, 28006
    • Complejo Hospitalario Ruber Juan Bravo
  • Salamanca, Spain, 37005
    • Hospital de Salamanca
  • Sevilla, Spain, 41009
    • Hospital Victoria Eugenia - Cruz Roja
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Barcelona
    • Sant Cugat del Valles, Barcelona, Spain, 08195
      • Hospital General de Catalunya
  • Bizkaia
    • Getxo, Bizkaia, Spain, 48993
      • Centro CAE Oroitu
  • Gipuzkoa
    • Donostia San Sebastian, Gipuzkoa, Spain, 20009
      • Fundación CITA-alzheimer Findazioa
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20014
      • Policlinica Guipuzcoa
• Sweden
  • Malmö, Sweden, 20502
    • Memory Clinic, Malmö University Hospital
  • Stockholm, Sweden, 141 86
    • Karolinska University Hospital
  • Uppsala, Sweden, 751 85
    • Uppsala University Hospital, Uppsala
  • Västra Götalandslän
    • Gothenburg, Västra Götalandslän, Sweden, 43141
      • Sahlgrenska University Hospital
• United Kingdom
  • Birmingham, United Kingdom, B16 8LT
    • Re:Cognition Health Ltd
  • Guildford, United Kingdom, GU2 7YD
    • Re:Cognition Health Ltd
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, EC2Y 8 EA
    • St. Pancras Clinical Research
  • London, United Kingdom, W1G 9JF
    • Re:Cognition Health Ltd
  • Devon
    • Plymouth, Devon, United Kingdom, PL6 8BT
      • RE:Cognition Health
  • Hampshire
    • Southampton, Hampshire, United Kingdom, SO30 3JB
      • Memory Assessment & Research Centre (MARC),
  • South Yorkshire
    • Sheffield, South Yorkshire, United Kingdom, S5 7JT
      • Sheffield Memory Service
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute- Clinical Trials Department
    • Sun City, Arizona, United States, 85351
      • Banner Sun Health Research
    • Tucson, Arizona, United States, 85718
      • Neurological Associates of Tucson dba Center for Neurosciences
  • California
    • Fullerton, California, United States, 92835
      • Neurology Center of North Orange County
    • Irvine, California, United States, 92614
      • Irvine Clinical Research
    • Los Angeles, California, United States, 90045
      • University of California - Los Angeles
    • Oxnard, California, United States, 93030
      • Pacific Neuroscience Medical Group
    • Palo Alto, California, United States, 94304
      • Stanford University Medical Center
    • San Diego, California, United States, 92123
      • Sharp Mesa Vista Hospital
    • San Diego, California, United States, 92103
      • Pacific Research Network, Inc
    • San Francisco, California, United States, 94158
      • UCSF Memory and Aging Center
    • Santa Ana, California, United States, 92705
      • Apex Research Institute
    • Santa Rosa, California, United States, 95403
      • St Joseph Heritage Healthcare
    • Sebastopol, California, United States, 95472
      • North Bay Neuroscience Research Institute
  • Colorado
    • Centennial, Colorado, United States, 80112
      • ImmunoE Research Center
    • Denver, Colorado, United States, 80218
      • Mile High Research Center
  • Connecticut
    • Fairfield, Connecticut, United States, 06824
      • Associated Neurologists of Southern Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University School of Medicine
    • New Haven, Connecticut, United States, 06510
      • Institute for Neurodegenerative Disorders
    • Norwalk, Connecticut, United States, 06851
      • Research Center for Clinical Studies, Inc.
  • District of Columbia
    • Washington, District of Columbia, United States, 20057
      • Georgetown University Hospital
  • Florida
    • Atlantis, Florida, United States, 33462
      • JEM Research Institute
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center, Inc.
    • Coral Gables, Florida, United States, 33134
      • Advanced Clinical Research Network
    • Coral Gables, Florida, United States, 33134
      • Linfritz Research Institute, Inc.
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest FL
    • Hollywood, Florida, United States, 33024
      • Infinity Clinical Research
    • Lady Lake, Florida, United States, 32159
      • Charter Research
    • Lake Worth, Florida, United States, 33449
      • Alzheimer's Research and Treatment Center
    • Maitland, Florida, United States, 32751
      • ClinCloud, LLC
    • Miami, Florida, United States, 33125
      • Gonzalez MD & Aswad MD Health Services
    • Miami, Florida, United States, 33126
      • BioMed Research Institute
    • Miami, Florida, United States, 33126
      • Finlay Medical Research
    • Miami, Florida, United States, 33133
      • CCM Clinical Research Group
    • Miami, Florida, United States, 33135
      • Rios Medical Center, Inc.
    • Miami, Florida, United States, 33135
      • Vitae Research Center
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Miami, Florida, United States, 33137
      • Visionary Investigators Network
    • Miami, Florida, United States, 33155
      • Allied Biomedical Research (Clinical Trial)
    • Miami, Florida, United States, 33175
      • Pharmax Research of South Florida, Inc
    • Miami, Florida, United States, 33180
      • Visionary Investigators Network
    • Miami Springs, Florida, United States, 33016
      • Galiz Research
    • Ocala, Florida, United States, 34470
      • Renstar Medical Research
    • Orlando, Florida, United States, 32806
      • Bioclinica Research
    • Ormond Beach, Florida, United States, 32174
      • Neurology Associates of Ormond Beach
    • Palm Beach Gardens, Florida, United States, 33410
      • Advanced Research Consultants, Inc.
    • Palmetto Bay, Florida, United States, 33157
      • IMIC, Inc.
    • Pompano Beach, Florida, United States, 33064
      • Quantum Laboratories Inc.
    • Port Charlotte, Florida, United States, 33952
      • Neurostudies, Inc.
    • Port Orange, Florida, United States, 32127
      • Progressive Medical Research
    • Stuart, Florida, United States, 34997
      • Alzheimer's Research and Treatment Center
    • Sunrise, Florida, United States, 33351
      • Infinity Clinical Research, LLC
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials, LLC
    • Tampa, Florida, United States, 33613
      • USF Suncoast Gerontology Center
    • The Villages, Florida, United States, 32162
      • Bioclinica Research
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute, West Palm
  • Georgia
    • Atlanta, Georgia, United States, 30329
      • Emory University Cognitive Neurology Clinic & ADRC
    • Columbus, Georgia, United States, 31909
      • Columbus Memory Center
    • Decatur, Georgia, United States, 30030
      • iResearch Atlanta, LLC
    • Decatur, Georgia, United States, 30033
      • NeuroStudies.net, LLC
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Hawaii Pacific Neuroscience
  • Illinois
    • Chicago, Illinois, United States, 60640
      • Great Lakes Clinical Trials
    • Park Ridge, Illinois, United States, 60068
      • Advocate Lutheran General Hospital
  • Indiana
    • Fort Wayne, Indiana, United States, 46804
      • Fort Wayne Neurological Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center Research Institute
    • Wichita, Kansas, United States, 67214
      • KU Wichita Center for Clinical Research
  • Massachusetts
    • Belmont, Massachusetts, United States, 02478
      • Partners Population Health
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Methuen, Massachusetts, United States, 01844
      • ActivMed Practices & Research
    • Newton, Massachusetts, United States, 02459
      • Boston Center for Memory
    • Plymouth, Massachusetts, United States, 02360
      • Donald S. Marks, MD. P.C.
  • Mississippi
    • Hattiesburg, Mississippi, United States, 39401
      • Hattiesburg Clinic
  • Missouri
    • Saint Louis, Missouri, United States, 63108
      • Washington University
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health
    • Las Vegas, Nevada, United States, 89113
      • Las Vegas Medical Research
  • New Jersey
    • Toms River, New Jersey, United States, 08755
      • Advanced Memory Research Institute of NJ, PC
    • Toms River, New Jersey, United States, 08755
      • Bio Behavioral Health
  • New York
    • Albany, New York, United States, 12208
      • Albany Medical College
    • Albany, New York, United States, 12208
      • Neurological Associates of Albany, PC
    • New York, New York, United States, 10016
      • New York University Medical Center PRIME
    • New York, New York, United States, 10032
      • Neurological Institute of New York
    • Rochester, New York, United States, 14620
      • University of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28270
      • ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates, P.A. - Research Department
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston Salem
  • Ohio
    • Canton, Ohio, United States, 44718
      • OH Clinical Research Partners
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43221
      • Ohio State University
    • Columbus, Ohio, United States, 43020
      • Columbs Neuroscience, LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97210
      • Summit Research Network (OR) Inc.
    • Portland, Oregon, United States, 97225
      • Neural Net Research, LLC
  • Pennsylvania
    • Norristown, Pennsylvania, United States, 19403
      • Keystone Clinical Studies, LLC
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island Mood & Memory Research Institute
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital - Memory and Aging Program
  • South Carolina
    • North Charleston, South Carolina, United States, 29406
      • Roper St. Francis Healthcare
    • Port Royal, South Carolina, United States, 29935
      • Coastal Neurology, P.A.
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic, P.C.
    • Knoxville, Tennessee, United States, 37920
      • Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adult Specialty Research
    • Dallas, Texas, United States, 75214
      • Texas Neurology, PA
    • Dallas, Texas, United States, 75231
      • Kerwin Research Center
    • Houston, Texas, United States, 77074
      • Clinical Trial Network
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine AD and Memory Disorders Center
  • Vermont
    • Bennington, Vermont, United States, 05201
      • DBA The Memory Clinic
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research Inc.-Richmond
  • Washington
    • Spokane, Washington, United States, 99202
      • Kingfisher Cooperative LLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Core Study: Inclusion Criteria

Diagnosis: Mild Cognitive Impairment (MCI) due to Alzheimer's disease - intermediate likelihood:

• Meet the National Institute of Aging - Alzheimer's Association (NIA-AA) core clinical criteria for MCI due to Alzheimer's disease - intermediate likelihood
• Have a global Clinical Dementia Rating (CDR) score of 0.5 and CDR Memory Box score of 0.5 or greater at Screening and Baseline
• Report a history of subjective memory decline with gradual onset and slow progression over the last 1 year before Screening; must be corroborated by an informant

Mild Alzheimer's disease dementia:

• Meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia
• Have a global CDR score of 0.5 to 1.0 and a CDR Memory Box score of 0.5 or greater at Screening and Baseline

Key Inclusion Criteria that must be met by all participants:

• Objective impairment in episodic memory as indicated by at least 1 standard deviation below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II (WMS-IV LMII)
• Positive biomarker for brain amyloid pathology
• Male or female participants aged greater than or equal to (>=) 50 and less than or equal to (<=) 90 years, at the time of informed consent
• Mini mental state examination (MMSE) score >=22 at Screening and Baseline and <=30 at Screening and Baseline
• Body mass index (BMI) greater than (>)17 and less than (<) 35 at Screening
• If receiving an approved Alzheimer's disease treatment such as acetylcholinesterase inhibitor (AChEIs) or memantine or both for Alzheimer's disease, must be on a stable dose for at least 12 weeks prior to Baseline. Treatment-naive participants for Alzheimer's disease can be entered into the study. Unless otherwise stated, participants must have been on stable doses of all other (that is, non-Alzheimer's disease-related) permitted concomitant medications for at least 4 weeks prior to Baseline. Use of memantine will not be allowed for participants in Japan
• Have an identified study partner (defined as a person able to support the participant for the duration of the study and who spends at least 8 hours per week with the participant)
• Provide written informed consent. If a participant lacks capacity to consent in the investigator's opinion, the participant's assent should be obtained, if required in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study (example, Germany and Spain), they will not be enrolled

Extension Phase: Inclusion Criteria:

• Participants who have completed the Core Study (except de novo participants)
• Must continue to have a study partner who is willing and able to provide follow-up information on the participant throughout the course of the Extension Phase
• Provide written informed consent for the Extension Phase. If a participant lacks capacity to consent in the investigator's opinion, the participant's assent should be obtained, if required and in accordance with local laws, regulations and customs, plus the written informed consent of a legal representative should be obtained (capacity to consent and definition of legal representative should be determined in accordance with applicable local laws and regulations). In countries where local laws, regulations, and customs do not permit participants who lack capacity to consent to participate in this study (example, Germany and Spain), they will not be enrolled
• Participants entering the subcutaneous (vial) substudy at Extension Phase Week 1, must be willing to participate, or continue participating in the amyloid positron emission tomography (PET) substudy. All participants must have an amyloid PET scan within 4 weeks before starting subcutaneous BAN2401.
• Participants enrolling into the subcutaneous autoinjector substudy must have had at least 6 months exposure to BAN2401 10 mg/kg intravenously (IV) biweekly or BAN2401 720 mg subcutaneously (SC) weekly.

Exclusion Criteria

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Core Study: Lecanemab 10 mg/kg biweekly	Drug: Lecanemab; 10 milligram per kilogram (mg/kg) biweekly (once every 2 weeks) administered as i.v. infusion.; Other Names: BAN2401; Drug: Lecanemab; 720 milligram (mg) weekly administered as subcutaneous injection.
Placebo Comparator: Core Study: Placebo	Drug: Placebo; Biweekly (once every 2 weeks) administered as i.v. infusion.
Experimental: Extension Phase: Lecanemab 10 mg/kg biweekly	Drug: Lecanemab; 10 milligram per kilogram (mg/kg) biweekly (once every 2 weeks) administered as i.v. infusion.; Other Names: BAN2401; Drug: Lecanemab; 720 milligram (mg) weekly administered as subcutaneous injection.
Experimental: Extension Phase: Lecanemab 720 mg Subcutaneous Injection Weekly; This will include approximately 40 de novo participants (those that did not participate in the core study) with early Alzheimer disease (AD).	Drug: Lecanemab; 10 milligram per kilogram (mg/kg) biweekly (once every 2 weeks) administered as i.v. infusion.; Other Names: BAN2401; Drug: Lecanemab; 720 milligram (mg) weekly administered as subcutaneous injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Core Study: Change from Baseline in the CDR-SB at 18 Months		Baseline, 18 months
Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)	A TEAE is defined as an adverse event 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) were 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.	From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase
Extension Phase: Change from Core Study Baseline in CDR-SB		Baseline up to Month 69

Secondary Outcome Measures

Outcome Measure	Time Frame
Core Phase: Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at 18 Months	Baseline, 18 months
Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months	Baseline, 18 months
Core Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months	Baseline, 18 months
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	Baseline, 18 months

Collaborators and Investigators

• Sponsor: Eisai Inc.
• Collaborators: Biogen

Study record dates

Study Major Dates

• Study Start (Actual): March 27, 2019
• Primary Completion (Estimated): September 15, 2027
• Study Completion (Estimated): September 15, 2027

Study Registration Dates

• First Submitted: March 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 25, 2019

Study Record Updates

• Last Update Posted (Actual): June 12, 2023
• Last Update Submitted That Met QC Criteria: June 9, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Mild cognitive impairment; BAN2401; Lecanemab; Clinical Dementia Rating-Sum of Boxes; Alzheimer's disease/prodromal Alzheimer's disease; Mild Alzheimer's disease dementia; Clarity AD
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: BAN2401-G000-301; 2018-004739-58 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No