Clinical trials›Early Alzheimer's Disease›Injection›Trial details
ActiveComing Soon (1–3 yrs) Treatment Study

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

For Condition: Early Alzheimer's Disease

ID: NCT03887455

Horizon Patient Guidance Summary

Our intelligence engine has synthesized this trial record to answer your most important questions in clear, simple terms:

How it’s taken
Injections / IV Shots
Expected Availability Horizon
Coming Soon (1–3 yrs away)
StageAdvanced Clinical Stage : Large-scale testing in thousands of patients. The final benchmark comparison phase closest to FDA approval and commercial release.
EligibleThis study is looking exclusively for patients diagnosed with the condition.
About This Clinical Trial

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 Full Scientific Objectives & Methods

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.

Study Timeline & Quick Facts
Trial Status
In Progress (Not Taking New Patients)
Total Target Enrollment
1.9K patients (Actual)
Study Start Date
2019-03-27
Est. Primary Completion
2029-06-30
Tested Drugs & Treatment Groups
DRUGLecanemab IV

Administered as IV infusion.

DRUGPlacebo

Biweekly (once every 2 weeks) administered as IVinfusion.

DRUGLecanemab SC

Administered weekly as a SC injection.

Treatment Arms Description

EXPERIMENTALCore Study: Lecanemab 10 milligram per kilogram (mg/kg) biweekly
PLACEBO_COMPARATORCore Study: Placebo
EXPERIMENTALExtension Phase: Lecanemab 10 mg/kg biweekly
EXPERIMENTALExtension Phase: Lecanemab Subcutaneous (SC) Injection Dose 1

This will include approximately 40 de novo participants (those that did not participate in the core study) with EAD.

EXPERIMENTALExtension Phase: Lecanemab SC Injection Dose 2
EXPERIMENTALExtension Phase: Lecanemab SC Injection Dose 3
EXPERIMENTALExtension Phase: Lecanemab SC Injection Dose 4
EXPERIMENTALExtension Phase: Lecanemab 10 mg/kg IV Infusion Once Every 4 Weeks (Q4W)
EXPERIMENTALExtension Phase B

Participants will receive Lecanemab 10 mg/kg IV infusion Q2W, or Q4W, or Dose 3, or Dose 4, SC injection, weekly.

Can I Join This Study?
Suitable For
Everyone welcome
Ages Welcome
Between 50 Years and 90 Years
Full Criteria Checklist
Who Can Join
  • 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
  • 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
  • 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 SC (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 SC BAN2401
  • Participants enrolling into the SC autoinjector substudy must have had at least 6 months exposure to BAN2401 10 mg/kg IV biweekly or at least 12 months exposure of BAN2401 Dose 1 subcutaneously weekly.
  • Participants enrolling into the SC Dose 3 autoinjector substudy must have previously received BAN2401 by either IV administration and/or SC autoinjector administration and must have completed Visit 82 (Extension Week 79) at a minimum, regardless of previous route of administration
  • Must have completed Week 207 in the Extension Phase
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
  • 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
  • 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)
  • 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
  • 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.
What is this Study Measuring?

Primary Outcome Measures

  • Core Study: Change from Baseline in the CDR-SB at 18 Months — Time Frame: Baseline, 18 months
  • Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs) — Time Frame: From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase

    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.

  • Extension Phase: Change from Core Study Baseline in CDR-SB — Time Frame: Baseline up to Month 66
  • Extension Phase Part B: Number of Participants Exposed to Lecanemab — Time Frame: From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)
View Secondary Outcome Measures (8)
  • Core Study: Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at 18 Months — Time Frame: Baseline, 18 months
  • Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months — Time Frame: Baseline, 18 months
  • Core Study: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months — Time Frame: 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 — Time Frame: Baseline, 18 months
  • Core Study: Number of Participants Reporting One or More TEAEs — Time Frame: From first dose of study drug up to approximately 21 months (including 3 months follow-up)

    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.

  • Core Study: Area Under the Curve of Lecanemab in Serum — Time Frame: Up to 21 months
  • Core Study: Average Concentration (Cav) of Lecanemab in Serum — Time Frame: Up to 21 months
  • Extension Phase Part B: Number of Participants Reporting AEs — Time Frame: From 48th month in extension phase part A to the end of extension phase part B (up to 24 months)
Where to Participate

This trial is recruiting at 247 study facilities worldwide. Click below to see if there is a clinic or hospital in your area:

Show All 247 Facilities & Contact Sites
Banner Alzheimer's Institute- Clinical Trials Department
Phoenix, Arizona, United States
Banner Sun Health Research
Sun City, Arizona, United States
Neurological Associates of Tucson dba Center for Neurosciences
Tucson, Arizona, United States
Neurology Center of North Orange County
Fullerton, California, United States
Irvine Clinical Research
Irvine, California, United States
University of California - Los Angeles
Los Angeles, California, United States
Pacific Neuroscience Medical Group
Oxnard, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Pacific Research Network, Inc
San Diego, California, United States
Sharp Mesa Vista Hospital
San Diego, California, United States
UCSF Memory and Aging Center
San Francisco, California, United States
Apex Research Institute
Santa Ana, California, United States
St Joseph Heritage Healthcare
Santa Rosa, California, United States
North Bay Neuroscience Research Institute
Sebastopol, California, United States
ImmunoE Research Center
Centennial, Colorado, United States
Mile High Research Center
Denver, Colorado, United States
Associated Neurologists of Southern Connecticut
Fairfield, Connecticut, United States
Institute for Neurodegenerative Disorders
New Haven, Connecticut, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
JEM Research Institute
Atlantis, Florida, United States
Bradenton Research Center, Inc.
Bradenton, Florida, United States
Advanced Clinical Research Network
Coral Gables, Florida, United States
Linfritz Research Institute, Inc.
Coral Gables, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest FL
Fort Myers, Florida, United States
Infinity Clinical Research
Hollywood, Florida, United States
Charter Research
Lady Lake, Florida, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States
Clincloud, LLC
Maitland, Florida, United States
Gonzalez MD & Aswad MD Health Services
Miami, Florida, United States
BioMed Research Institute
Miami, Florida, United States
Finlay Medical Research
Miami, Florida, United States
CCM Clinical Research Group
Miami, Florida, United States
Rios Medical Center, Inc.
Miami, Florida, United States
Vitae Research Center
Miami, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Allied Biomedical Research (Clinical Trial)
Miami, Florida, United States
Pharmax Research of South Florida, Inc
Miami, Florida, United States
Visionary Investigators Network
Miami, Florida, United States
Galiz Research
Miami Springs, Florida, United States
Renstar Medical Research
Ocala, Florida, United States
Bioclinica Research
Orlando, Florida, United States
Neurology Associates of Ormond Beach
Ormond Beach, Florida, United States
Advanced Research Consultants, Inc.
Palm Beach Gardens, Florida, United States
IMIC, Inc.
Palmetto Bay, Florida, United States
Quantum Laboratories Inc.
Pompano Beach, Florida, United States
Neurostudies, Inc.
Port Charlotte, Florida, United States
Progressive Medical Research
Port Orange, Florida, United States
Alzheimer's Research and Treatment Center
Stuart, Florida, United States
Infinity Clinical Research, LLC
Sunrise, Florida, United States
Stedman Clinical Trials, LLC
Tampa, Florida, United States
USF Suncoast Gerontology Center
Tampa, Florida, United States
Bioclinica Research
The Villages, Florida, United States
Premiere Research Institute, West Palm
West Palm Beach, Florida, United States
Emory University Cognitive Neurology Clinic & ADRC
Atlanta, Georgia, United States
Columbus Memory Center
Columbus, Georgia, United States
iResearch Atlanta, LLC
Decatur, Georgia, United States
NeuroStudies.net, LLC
Decatur, Georgia, United States
Hawaii Pacific Neuroscience
Honolulu, Hawaii, United States
Great Lakes Clinical Trials
Chicago, Illinois, United States
Advocate Lutheran General Hospital
Park Ridge, Illinois, United States
Fort Wayne Neurological Center
Fort Wayne, Indiana, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
KU Wichita Center for Clinical Research
Wichita, Kansas, United States
Partners Population Health
Belmont, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
ActivMed Practices & Research
Methuen, Massachusetts, United States
Boston Center for Memory
Newton, Massachusetts, United States
Donald S. Marks, MD. P.C.
Plymouth, Massachusetts, United States
Hattiesburg Clinic
Hattiesburg, Mississippi, United States
Washington University
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Las Vegas Medical Research
Las Vegas, Nevada, United States
Advanced Memory Research Institute of NJ, PC
Toms River, New Jersey, United States
Bio Behavioral Health
Toms River, New Jersey, United States
Albany Medical College
Albany, New York, United States
Neurological Associates of Albany, PC
Albany, New York, United States
New York University Medical Center PRIME
New York, New York, United States
Neurological Institute of New York
New York, New York, United States
University of Rochester
Rochester, New York, United States
ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
Charlotte, North Carolina, United States
Raleigh Neurology Associates, P.A. - Research Department
Raleigh, North Carolina, United States
PMG Research of Winston Salem
Winston-Salem, North Carolina, United States
OH Clinical Research Partners
Canton, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Columbs Neuroscience, LLC
Columbus, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Summit Research Network (OR) Inc.
Portland, Oregon, United States
Neural Net Research, LLC
Portland, Oregon, United States
Oregon Health & Science University
Portland, Oregon, United States
Keystone Clinical Studies, LLC
Norristown, Pennsylvania, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Rhode Island Mood & Memory Research Institute
East Providence, Rhode Island, United States
Rhode Island Hospital
Providence, Rhode Island, United States
Butler Hospital - Memory and Aging Program
Providence, Rhode Island, United States
Roper St. Francis Healthcare
North Charleston, South Carolina, United States
Coastal Neurology, P.A.
Port Royal, South Carolina, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company
Knoxville, Tennessee, United States
Senior Adult Specialty Research
Austin, Texas, United States
Texas Neurology, PA
Dallas, Texas, United States
Kerwin Research Center
Dallas, Texas, United States
Baylor College of Medicine AD and Memory Disorders Center
Houston, Texas, United States
Clinical Trial Network
Houston, Texas, United States
DBA The Memory Clinic
Bennington, Vermont, United States
National Clinical Research Inc.-Richmond
Richmond, Virginia, United States
Kingfisher Cooperative LLC
Spokane, Washington, United States
St Vincent's Hospital - Translational Research Centre
Darlinghurst, New South Wales, Australia
KaRa Institute of Neurological Diseases
Macquarie Park, New South Wales, Australia
The Prince Charles Hospital/Internal Medicine & Dementia Research Unit
Chermside Brisbane, Queensland, Australia
Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital
Woodville South, Adelaid, South Australia, Australia
Austin Health - Medical and Cognitive Research Unit
Ivanhoe, Victoria, Australia
HammondCare Malvern Clinical Trials Unit
Malvern, Victoria, Australia
Australian Alzheimer's Research Foundation
Nedlands, Western Australia, Australia
Okanagan Clinical Trials
Kelowna, British Columbia, Canada
Health Research
West Vancouver, British Columbia, Canada
True North Clinical Research Halifax, Inc.
Halifax, Nova Scotia, Canada
True North Clinical Research Kentville, Inc.
Kentville, Nova Scotia, Canada
St. Joseph's HC- Parkwood Institute
London, Ontario, Canada
Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic
Ottawa, Ontario, Canada
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, Canada
Toronto Memory Program (Neurology Research Inc.)
Toronto, Ontario, Canada
Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais
Gatineau, Quebec, Canada
MoCA Clinic and Institute/NeuroSearch Developpements Inc.
Greenfield Park, Quebec, Canada
Q&T Research Sherbrooke Inc.
Sherbrooke, Quebec, Canada
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Xuanwu Hospital Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Guangzhou First People's Hospital
Guangzhou, Guangdong, China
Guangzhou Huiai Hospital
Guangzhou, Guangdong, China
Guangdong Provincial People's Hospital
Guangzhou, Guangzhou, China
The Second Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Baotou Central Hospital
Baotou, Inner Mongolia, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Nanjing Brain Hospital, Affiliated to Nanjing Medical University
Nanjing, Jiangsu, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, China
Qinghai Provincial People's Hospital
Xining, Qinghai, China
Jinan Central Hospital
Jinan, Shandong, China
Shanghai Tongji Hospital
Shanghai, Shanghai Municipality, China
Renji Hospital Shanghai Jiaotong Universtiy School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai Sixth People's Hospital
Shanghai, Shanghai Municipality, China
Tianjin Huanhu Hospital
Tianjin, Tianjin Municipality, China
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Hôpital de Hautepierre
Strasbourg, Bas Rhin, France
Hopital de la Timone
Marseille, Cedex 05, France
Hôpital Gui de Chauliac
Montpellier, Cedex 5, France
Hopital Guillaume et Renà LaÃnnec
Nantes, Cedex, France
Groupe Hospitalier Pitie-Salpetriere
Paris, Cedex, France
Centre de Recherche Clinique du Gérontopôle
Toulouse, Haute Garonne, France
Hôpital Lariboisière
Paris, Paris, France
Hôpital neurologique Pierre Wertheimer
Bron, France
Eisai Trial Site #5
Günzburg, Baden-Wurttemberg, Germany
Eisai Trial Site #2
Mannheim, Baden-Wurttemberg, Germany
Eisai Trial Site #6
Berlin, Germany
Eisai Trial Site #1
Bielefeld, Germany
Eisai Trial Site #4
Erbach im Odenwald, Germany
Eisai Trial Site #3
München, Germany
Ospedale "Card. G. Panico" -
Tricase, LE, Italy
Fondazione Istituto G.Giglio di Cefalù
Cefalù, Palermo, Italy
Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova
Genova, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative
Milan, Italy
ASST-Monza, Ospedale San Gerardo
Monza, Italy
Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"
Naples, Italy
Ospedale S. Maria della Misericordia, S. Andrea delle Fratte
Perugia, Italy
Azienda Ospedaliero Universitaria Pisana
Pisa, Italy
Fondazione Policlinico Agostino Gemelli - UCSC
Roma, Italy
Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane
Roma, Italy
Eisai Trial Site #4
Obu-shi, Aichi-ken, Japan
Eisai Trial Site #15
Chiba, Chiba, Japan
Eisai Trial Site #6
Yoshida-gun, Fukui, Japan
Eisai Trial Site #1
Fujioka-shi, Gunma, Japan
Eisai Trial Site #32
Ōtake, Hiroshima, Japan
Eisai Trial Site #30
Sapporo, Hokkaido, Japan
Eisai Trial Site #28
Himeji-shi, Hyōgo, Japan
Eisai Trial Site #19
Kobe, Hyōgo, Japan
Eisai Trial Site #24
Toride-shi, Ibaraki, Japan
Eisai Trial Site #9
Kahoku, Ishikawa-ken, Japan
Eisai Trial Site #7
Atsugi-shi, Kanagawa, Japan
Eisai Trial Site #17
Fujisawa-shi, Kanagawa, Japan
Eisai Trial Site #20
Kawasaki-shi, Kanagawa, Japan
Eisai Trial Site #2
Yokohama, Kanagawa, Japan
Eisai Trial Site #33
Higashimorokatagun, Miyazaki, Japan
Eisai Trial Site #22
Niigata, Niigata, Japan
Eisai Trial Site #16
Kurashiki-shi, Okayama-ken, Japan
Eisai Trial Site #8
Hirakata, Osaka, Japan
Eisai Trial Site #26
Suita-shi, Osaka, Japan
Eisai Trial Site #18
Saitama-shi, Saitama, Japan
Eisai Trial Site #31
Ōtsu, Shiga, Japan
Eisai Trial Site #5
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site #29
Bunkyo-ku, Tokyo, Japan
Eisai Trial Site #13
Hachioji-shi, Tokyo, Japan
Eisai Trial Site #12
Musashino-shi, Tokyo, Japan
Eisai Trial Site #23
Shinagawa-ku, Tokyo, Japan
Eisai Trial Site #25
Shinjuku-ku, Tokyo, Japan
Eisai Trial Site #10
Shinjuku-ku, Tokyo, Japan
Eisai Trial Site #3
Yamagata, Yamagata, Japan
Eisai Trial Site #21
Hōfu, Yamaguchi, Japan
Eisai Trial Site #14
Ube-shi, Yamaguchi, Japan
Eisai Trial Site #11
Osaka, Japan
Eisai Trial Site #27
Osaka, Japan
First Moscow State Medical University n.a. I.M. Sechenov
Moscow, Russia
National University Hospital
Singapore, Singapore
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Chonnam National University Hospital
Gwangju, Jeolla-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Seoul, South Korea
Dong-A University Hospital
Busan, South Korea
Inha University Hospital
Incheon, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Hanyang University Seoul Hospital
Seoul, South Korea
Konkuk University Medical Center
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
The Catholic University of Korea, Seoul ST. Mary's Hospital
Seoul, South Korea
Seoul National University Boramae Medical Center
Seoul, South Korea
Hospital General de Catalunya
Sant Cugat del Vallès, Barcelona, Spain
Centro CAE Oroitu
Getxo, Bizkaia, Spain
Fundación CITA-alzheimer Findazioa
Donostia / San Sebastian, Gipuzkoa, Spain
Policlinica Guipuzcoa
Donostia / San Sebastian, Guipuzcoa, Spain
Fundacion ACE, Barcelona
Barcelona, Spain
Hospital Clinic i Provincial de Barcelona
Barcelona, Spain
Hospital Santa Cruz y San Pablo
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Complejo Hospitalario Ruber Juan Bravo
Madrid, Spain
Hospital de Salamanca
Salamanca, Spain
Hospital Victoria Eugenia - Cruz Roja
Seville, Spain
Hospital Universitari i Politècnic La Fe
Valencia, Spain
Sahlgrenska University Hospital
Gothenburg, Västra Götalandslän, Sweden
Memory Clinic, Malmö University Hospital
Malmö, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital, Uppsala
Uppsala, Sweden
Re:Cognition Health
Plymouth, Devon, United Kingdom
Memory Assessment & Research Centre (MARC),
Southampton, Hampshire, United Kingdom
Sheffield Memory Service
Sheffield, South Yorkshire, United Kingdom
Re:Cognition Health Ltd
Birmingham, United Kingdom
Re:Cognition Health Ltd
Guildford, United Kingdom
St. Pancras Clinical Research
London, United Kingdom
Re:Cognition Health Ltd
London, United Kingdom
Charing Cross Hospital
London, United Kingdom
Trial Design & Scientific Setup
Allocation
randomized
Intervention Model
parallel
Primary Purpose
treatment
Masking
quadruple (participant, care_provider, investigator, outcomes_assessor)
Sponsoring Teams & Contacts
Lead Sponsoring Institution
Eisai Inc.
Collaborators: Biogen
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Scientific Literature & 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
  • 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 ↗
View Official Medical/Scientific 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