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

Phase 3

Active, not recruiting

• Conditions: Early Alzheimer's Disease
• Interventions: Drug: Lecanemab; Drug: Placebo

• Registration Number: NCT03887455
• Lead Sponsor: Eisai Inc.

Brief Summary

This study will be conducted to evaluate the efficacy of lecanemab in participants with early Alzheimer's disease (EAD) by determining the superiority of lecanemab compared with placebo on the change from baseline in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) at 18 months of treatment in the Core Study. This study will also evaluate the long-term saf...

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2019-03-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-25
• Study Start: 2019-03-27
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-08
• Last Update Posted: 2024-07-09
• Primary Completion: 2027-09-15
• Study Completion: 2027-09-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1906

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 biweekly or BAN2401 720 mg subcutaneously weekly.
• Participants enrolling into the subcutaneous 360 mg autoinjector substudy must have previously received BAN2401 by either intravenous administration and/or subcutaneous autoinjector administration and must have completed Visit 82 (Extension Week 79) at a minimum, regardless of previous route of administration

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

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extension Phase: Lecanemab 10 mg/kg biweekly	Lecanemab	-
Extension Phase: Lecanemab 360 mg Subcutaneous Autoinjector Injection Weekly	Lecanemab	-
Core Study: Placebo	Placebo	-
Extension Phase: Lecanemab 720 mg Subcutaneous Injection Weekly	Lecanemab	This will include approximately 40 de novo participants (those that did not participate in the core study) with early Alzheimer disease (AD).
Core Study: Lecanemab 10 mg/kg biweekly	Lecanemab	-

Primary Outcome Measures

Name	Time	Method
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)	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 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 adv...
Extension Phase: Change from Core Study Baseline in CDR-SB	Baseline up to Month 69

Secondary Outcome Measures

Name	Time	Method
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 Amyloid Positron Emission Tomography (PET) Using Centiloids 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

Trial Locations

Locations (235)

Emory University Cognitive Neurology Clinic & ADRC; 🇺🇸 Atlanta, Georgia, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

Ohio State University; 🇺🇸 Columbus, Ohio, United States

Hôpital neurologique Pierre Wertheimer; 🇫🇷 Bron Cedex, France

Eisai Trial Site #2; 🇯🇵 Yokohama-shi, Kanagawa, Japan

Eisai Trial Site #1; 🇯🇵 Fujioka-shi, Gunma, Japan

JEM Research Institute; 🇺🇸 Atlantis, Florida, United States

Bradenton Research Center, Inc.; 🇺🇸 Bradenton, Florida, United States

Advanced Clinical Research Network; 🇺🇸 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; 🇺🇸 Stuart, Florida, United States

Galiz Research; 🇺🇸 Miami Springs, Florida, United States

Clincloud, LLC; 🇺🇸 Maitland, Florida, United States

Bioclinica Research; 🇺🇸 The Villages, Florida, United States

Renstar Medical Research; 🇺🇸 Ocala, 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

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company; 🇺🇸 Knoxville, Tennessee, United States

DBA The Memory Clinic; 🇺🇸 Bennington, Vermont, United States

The Prince Charles Hospital/Internal Medicine & Dementia Research Unit; 🇦🇺 Chermside Brisbane, Queensland, Australia

Okanagan Clinical Trials; 🇨🇦 Kelowna, British Columbia, Canada

True North Clinical Research Kentville, Inc.; 🇨🇦 Kentville, Nova Scotia, Canada

Guangzhou First People's Hospital; 🇨🇳 Guangzhou, Guangdong, China

Xiangya Hospital Central South University; 🇨🇳 Changsha, Hunan, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

Hopital de la Timone; 🇫🇷 Marseille, Cedex 05, France

Centre de Recherche Clinique du Gérontopôle; 🇫🇷 Toulouse, Haute Garonne, France

Eisai Trial Site #7; 🇯🇵 Atsugi-shi, Kanagawa, Japan

Eisai Trial Site #20; 🇯🇵 Kawasaki-shi, Kanagawa, Japan

Eisai Trial Site #33; 🇯🇵 Higashimorokatagun, Miyazaki, Japan

Eisai Trial Site #22; 🇯🇵 Niigata-shi, Niigata, Japan

Eisai Trial Site #18; 🇯🇵 Saitama-shi, Saitama, Japan

Eisai Trial Site #12; 🇯🇵 Musashino-shi, Tokyo, Japan

Eisai Trial Site #25; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Policlinica Guipuzcoa; 🇪🇸 San Sebastian, Guipuzcoa, Spain

Visionary Investigators Network; 🇺🇸 Miami, Florida, United States

Allied Biomedical Research (Clinical Trial); 🇺🇸 Miami, Florida, United States

Gonzalez MD & Aswad MD Health Services; 🇺🇸 Miami, Florida, United States

BioMed Research Institute; 🇺🇸 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

Pharmax Research of South Florida, Inc; 🇺🇸 Miami, Florida, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States

KU Wichita Center for Clinical Research; 🇺🇸 Wichita, Kansas, United States

Centro CAE Oroitu; 🇪🇸 Getxo, Bizkaia, Spain

University of Kansas Medical Center Research Institute; 🇺🇸 Kansas City, Kansas, United States

ImmunoE Research Center; 🇺🇸 Centennial, Colorado, United States

Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova; 🇮🇹 Genova, Italy

Fondazione Policlinico Agostino Gemelli - UCSC; 🇮🇹 Roma, Italy

Banner Alzheimer's Institute- Clinical Trials Department; 🇺🇸 Phoenix, Arizona, United States

Cleveland Clinic Lou Ruvo Center for Brain Health; 🇺🇸 Las Vegas, Nevada, United States

Las Vegas Medical Research; 🇺🇸 Las Vegas, Nevada, United States

Lynn Health Science Institute; 🇺🇸 Oklahoma City, Oklahoma, United States

Hôpital de Hautepierre; 🇫🇷 Strasbourg Cedex, Bas Rhin, France

Mile High Research Center; 🇺🇸 Denver, Colorado, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

Banner Sun Health Research; 🇺🇸 Sun City, Arizona, United States

Neurology Center of North Orange County; 🇺🇸 Fullerton, California, United States

Irvine Clinical Research; 🇺🇸 Irvine, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

Sharp Mesa Vista Hospital; 🇺🇸 San Diego, California, United States

Pacific Research Network, Inc; 🇺🇸 San Diego, California, United States

Apex Research Institute; 🇺🇸 Santa Ana, California, United States

UCSF Memory and Aging Center; 🇺🇸 San Francisco, California, United States

North Bay Neuroscience Research Institute; 🇺🇸 Sebastopol, California, United States

St Joseph Heritage Healthcare; 🇺🇸 Santa Rosa, California, United States

Georgetown University Hospital; 🇺🇸 Washington, District of Columbia, United States

Linfritz Research Institute, Inc.; 🇺🇸 Coral Gables, Florida, United States

Finlay Medical Research; 🇺🇸 Miami, Florida, United States

Infinity Clinical Research, LLC; 🇺🇸 Sunrise, Florida, United States

USF Suncoast Gerontology Center; 🇺🇸 Tampa, Florida, United States

Premiere Research Institute, West Palm; 🇺🇸 West Palm Beach, Florida, United States

NeuroStudies.net, LLC; 🇺🇸 Decatur, Georgia, United States

iResearch Atlanta, LLC; 🇺🇸 Decatur, Georgia, United States

Fort Wayne Neurological Center; 🇺🇸 Fort Wayne, Indiana, United States

Advocate Lutheran General Hospital; 🇺🇸 Park Ridge, Illinois, United States

Great Lakes Clinical Trials; 🇺🇸 Chicago, Illinois, United States

Partners Population Health; 🇺🇸 Belmont, Massachusetts, United States

ActivMed Practices & Research; 🇺🇸 Methuen, Massachusetts, United States

Donald S. Marks, MD. P.C.; 🇺🇸 Plymouth, Massachusetts, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Advanced Memory Research Institute of NJ, PC; 🇺🇸 Toms River, New Jersey, United States

Albany Medical College; 🇺🇸 Albany, New York, United States

Bio Behavioral Health; 🇺🇸 Toms River, New Jersey, United States

Neurological Associates of Albany, PC; 🇺🇸 Albany, New York, United States

New York University Medical Center PRIME; 🇺🇸 New York, New York, United States

University of Rochester; 🇺🇸 Rochester, New York, United States

Neurological Institute of New York; 🇺🇸 New York, New York, United States

Raleigh Neurology Associates, P.A. - Research Department; 🇺🇸 Raleigh, North Carolina, United States

ANI Neurology, PLLC d/b/a Alzheimer's Memory Center; 🇺🇸 Charlotte, North Carolina, United States

Columbs Neuroscience, LLC; 🇺🇸 Columbus, Ohio, United States

Summit Research Network (OR) Inc.; 🇺🇸 Portland, Oregon, United States

Neural Net Research, LLC; 🇺🇸 Portland, Oregon, United States

Keystone Clinical Studies, LLC; 🇺🇸 Norristown, Pennsylvania, United States

Butler Hospital - Memory and Aging Program; 🇺🇸 Providence, Rhode Island, United States

Rhode Island Mood & Memory Research Institute; 🇺🇸 East 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

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

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

Kingfisher Cooperative LLC; 🇺🇸 Spokane, Washington, United States

KaRa Institute of Neurological Diseases; 🇦🇺 Macquarie Park, New South Wales, Australia

HammondCare Malvern Clinical Trials Unit; 🇦🇺 Malvern, Victoria, Australia

Austin Health - Medical and Cognitive Research Unit; 🇦🇺 Ivanhoe, Victoria, Australia

Australian Alzheimer's Research Foundation; 🇦🇺 Nedlands, Western Australia, Australia

Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic; 🇨🇦 Ottawa, Ontario, Canada

Kawartha Centre - Redefining Healthy Aging; 🇨🇦 Peterborough, Ontario, Canada

Health Research; 🇨🇦 West Vancouver, British Columbia, Canada

St. Joseph's HC- Parkwood Institute; 🇨🇦 London, Ontario, Canada

True North Clinical Research Halifax, Inc.; 🇨🇦 Halifax, Nova Scotia, 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, China

Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University; 🇨🇳 Guangzhou, Guangdong, China

Beijing Tiantan Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Xuanwu Hospital Capital Medical University; 🇨🇳 Beijing, Beijing, China

Guangzhou Huiai Hospital; 🇨🇳 Guangzhou, Guangdong, China

Henan Provincial People's Hospital; 🇨🇳 Zhengzhou, Henan, China

Guangdong Provincial People's Hospital; 🇨🇳 Guangzhou, Guangzhou, China

The Second Hospital of Hebei Medical University; 🇨🇳 Shijiazhuang, Hebei, China

Nanjing Drum Tower Hospital; 🇨🇳 Nanjing, Jiangsu, China

Baotou Central Hospital; 🇨🇳 Baotou, Inner Mongolia Autonomous Region, China

Nanjing Brain Hospital, Affiliated to Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China

The First Bethune Hospital of Jilin University; 🇨🇳 Changchun, Jilin, China

Shanghai Tongji Hospital; 🇨🇳 Shanghai, Shanghai, China

Jinan Central Hospital; 🇨🇳 Jinan, Shandong, China

Qinghai Provincial People's Hospital; 🇨🇳 Xining, Qinghai, China

Renji Hospital Shanghai Jiaotong Universtiy School of Medicine; 🇨🇳 Shanghai, Shanghai, China

Tianjin Huanhu Hospital; 🇨🇳 Tianjin, Tianjin, China

Shanghai Sixth People's Hospital; 🇨🇳 Shanghai, Shanghai, China

Hôpital Gui de Chauliac; 🇫🇷 Montpellier, Cedex 5, France

Groupe Hospitalier Pitie-Salpetriere; 🇫🇷 Paris, Cedex, France

Hopital Guillaume et Renà LaÃnnec; 🇫🇷 Nantes, Cedex, France

Hôpital Lariboisière; 🇫🇷 Paris cedex 10, Paris, France

Eisai Trial Site #6; 🇯🇵 Yoshida-gun, Fukui, Japan

Eisai Trial Site #5; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Fondazione Istituto G.Giglio di Cefalù; 🇮🇹 Cefalu, Palermo, Italy

Ospedale "Card. G. Panico" -; 🇮🇹 Tricase, LE, Italy

ASST-Monza, Ospedale San Gerardo; 🇮🇹 Monza, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative; 🇮🇹 Milano, Italy

Ospedale S. Maria della Misericordia, S. Andrea delle Fratte; 🇮🇹 Perugia, Italy

Azienda Ospedaliero Universitaria Pisana; 🇮🇹 Pisa, Italy

Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane; 🇮🇹 Roma, Italy

Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"; 🇮🇹 Napoli, Italy

Eisai Trial Site #15; 🇯🇵 Chiba-shi, Chiba, Japan

Eisai Trial Site #32; 🇯🇵 Otake, Hiroshima, Japan

Eisai Trial Site #28; 🇯🇵 Himeji-shi, Hyogo, Japan

Eisai Trial Site #24; 🇯🇵 Toride-shi, Ibaraki, Japan

Eisai Trial Site #30; 🇯🇵 Sapporo-shi, Hokkaido, Japan

Eisai Trial Site #19; 🇯🇵 Kobe-shi, Hyogo, Japan

Eisai Trial Site #9; 🇯🇵 Kahoku, Ishikawa, Japan

Eisai Trial Site #17; 🇯🇵 Fujisawa-shi, Kanagawa, Japan

Eisai Trial Site #8; 🇯🇵 Hirakata, Osaka, Japan

Eisai Trial Site #26; 🇯🇵 Suita-shi, Osaka, Japan

Eisai Trial Site #31; 🇯🇵 Otsu-shi, Shiga, Japan

Eisai Trial Site #13; 🇯🇵 Hachioji-shi, Tokyo, Japan

Eisai Trial Site #23; 🇯🇵 Shinagawa-ku, Tokyo, Japan

Eisai Trial Site #10; 🇯🇵 Shinjuku-ku, Tokyo, Japan

Eisai Trial Site #14; 🇯🇵 Ube-shi, Yamaguchi, Japan

Eisai Trial Site #11; 🇯🇵 Osaka, Japan

Seoul National University Bundang Hospital; 🇰🇷 Seongnam-si, Seoul, Korea, Republic of

Eisai Trial Site #27; 🇯🇵 Osaka, Japan

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Chonnam National University Hospital; 🇰🇷 Gwangju, Jeolla-do, Korea, Republic of

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of

Inha University Hospital; 🇰🇷 Incheon, Korea, Republic of

Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Hanyang University Seoul Hospital; 🇰🇷 Seoul, Korea, Republic of

Konkuk University Medical Center; 🇰🇷 Seoul, Korea, Republic of

Asan Medical Center; 🇰🇷 Seoul, Korea, Republic of

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of

The Catholic University of Korea, Seoul ST. Mary's Hospital; 🇰🇷 Seoul, Korea, Republic of

Seoul National University Boramae Medical Center; 🇰🇷 Seoul, Korea, Republic of

First Moscow State Medical University n.a. I.M. Sechenov; 🇷🇺 Moscow, Russian Federation

Hospital General de Catalunya; 🇪🇸 Sant Cugat del Valles, Barcelona, Spain

National University Hospital; 🇸🇬 Singapore, Singapore

Fundación CITA-alzheimer Findazioa; 🇪🇸 Donostia San Sebastian, Gipuzkoa, 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; 🇪🇸 Cordoba, Spain

Complejo Hospitalario Ruber Juan Bravo; 🇪🇸 Madrid, Spain

Hospital Victoria Eugenia - Cruz Roja; 🇪🇸 Sevilla, Spain

Hospital de Salamanca; 🇪🇸 Salamanca, Spain

Hospital Universitari i Politècnic La Fe; 🇪🇸 Valencia, Spain

Memory Clinic, Malmö University Hospital; 🇸🇪 Malmö, Sweden

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västra Götalandslän, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Uppsala University Hospital, Uppsala; 🇸🇪 Uppsala, Sweden

Re:Cognition Health Ltd; 🇬🇧 London, United Kingdom

Sheffield Memory Service; 🇬🇧 Sheffield, South Yorkshire, United Kingdom

St. Pancras Clinical Research; 🇬🇧 London, United Kingdom

Stedman Clinical Trials, LLC; 🇺🇸 Tampa, Florida, United States

Texas Neurology, PA; 🇺🇸 Dallas, Texas, United States

Pacific Neuroscience Medical Group; 🇺🇸 Oxnard, California, United States

Columbus Memory Center; 🇺🇸 Columbus, Georgia, United States

University of California - Los Angeles; 🇺🇸 Los Angeles, California, United States

St Vincent's Hospital - Translational Research Centre; 🇦🇺 Darlinghurst, New South Wales, Australia

Institute for Neurodegenerative Disorders; 🇺🇸 New Haven, Connecticut, United States

Yale University School Of Medicine; 🇺🇸 New Haven, Connecticut, United States

PMG Research of Winston Salem; 🇺🇸 Winston-Salem, North Carolina, United States

OH Clinical Research Partners; 🇺🇸 Canton, Ohio, United States

Eisai Trial Site #21; 🇯🇵 Hofu, Yamaguchi, Japan

Research Center for Clinical Studies, Inc.; 🇺🇸 Norwalk, Connecticut, United States

Associated Neurologists of Southern Connecticut; 🇺🇸 Fairfield, Connecticut, United States

Boston Center for Memory; 🇺🇸 Newton, Massachusetts, United States

Hattiesburg Clinic; 🇺🇸 Hattiesburg, Mississippi, United States

Eisai Trial Site #3; 🇯🇵 Yamagata-shi, Yamagata, Japan

Eisai Trial Site #16; 🇯🇵 Kurashiki-shi, Okayama, Japan

Eisai Trial Site #29; 🇯🇵 Bunkyo-ku, Tokyo, Japan

Eisai Trial Site #4; 🇯🇵 Obu-shi, Aichi, Japan

Memory Assessment & Research Centre (MARC),; 🇬🇧 Southampton, Hampshire, United Kingdom

Neurological Associates of Tucson dba Center for Neurosciences; 🇺🇸 Tucson, Arizona, United States

Re:Cognition Health; 🇬🇧 Plymouth, Devon, United Kingdom

Senior Adult Specialty Research; 🇺🇸 Austin, Texas, United States

National Clinical Research Inc.-Richmond; 🇺🇸 Richmond, Virginia, United States

Hawaii Pacific Neuroscience; 🇺🇸 Honolulu, Hawaii, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States

Charing Cross Hospital; 🇬🇧 London, United Kingdom