Phase 3 Active, not recruiting NCT03887455

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

Eisai Inc. · Interventional, Randomized

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Enrollment closed (started March 2019). Expected completion: June 2029.

Study context: no flags matched. Amendment history is not available for this trial's data source.

Overview

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.

Full record on ClinicalTrials.gov (NCT ID NCT03887455).

Recruitment criteria

Age range: 50–90 · Sex: All · Healthy volunteers: Requires diagnosis

Study design

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Masking
Quadruple-blind
Intervention model
Parallel assignment
Primary purpose
Treatment
Enrollment target
— participants
Started
March 2019
Estimated completion
June 2029

Outcome measures

Locations & contacts

Filter by location Showing 247 of 247 sites

247 sites currently enrolling. Representative sites shown below; full site list on ClinicalTrials.gov.

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)

Sources

REG
ClinicalTrials.gov — NCT03887455
Trial registry · primary record
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