Clinical trial NCT03887455: A Study to Confirm Safety and Efficacy of Lecanemab in Participants With Early Alzheimer's Disease
Official title: A Placebo-Controlled, Double-Blind, Parallel-Group, 18-Month Study With an Open-Label Extension Phase to Confirm Safety and Efficacy of BAN2401 in Subjects With Early Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Early Alzheimer's Disease
Keywords: BAN2401
Clinical Dementia Rating-Sum of Boxes
Mild cognitive impairment
Alzheimer's disease/prodromal Alzheimer's disease
Mild Alzheimer's disease dementia
Clarity AD
Lecanemab
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
Collaborators: name: Biogen
First posted: 2019-03-25
Enrollment: 1906
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Eligibility criteria: 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 biweekly or BAN2401 Dose 1 subcutaneously weekly.
* Participants enrolling into the subcutaneous Dose 3 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

Primary outcomes:
measure: Core Study: Change from Baseline in the CDR-SB at 18 Months
timeFrame: Baseline, 18 months
measure: Extension Phase: Number of Participants Reporting One or More Treatment-emergent Adverse Events (TEAEs)
timeFrame: From first dose of study drug up to approximately 51 months (including 3 months follow up) for the extension phase
measure: Extension Phase: Change from Core Study Baseline in CDR-SB
timeFrame: Baseline up to Month 69
Secondary outcomes:
measure: Core Phase: Change From Baseline in Amyloid Positron Emission Tomography (PET) Using Centiloids at 18 Months
timeFrame: Baseline, 18 months
measure: Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months
timeFrame: Baseline, 18 months
measure: Core Phase: Change From Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months
timeFrame: Baseline, 18 months
measure: 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
timeFrame: Baseline, 18 months
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner Alzheimer's Institute- Clinical Trials Department
state: Arizona
city: Sun City
country: United States
facility: Banner Sun Health Research
state: Arizona
city: Tucson
country: United States
facility: Neurological Associates of Tucson dba Center for Neurosciences
state: Arizona
city: Fullerton
country: United States
facility: Neurology Center of North Orange County
state: California
city: Irvine
country: United States
facility: Irvine Clinical Research
state: California
city: Los Angeles
country: United States
facility: University of California - Los Angeles
state: California
city: Oxnard
country: United States
facility: Pacific Neuroscience Medical Group
state: California
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
city: San Diego
country: United States
facility: Pacific Research Network, Inc
state: California
city: San Diego
country: United States
facility: Sharp Mesa Vista Hospital
state: California
city: San Francisco
country: United States
facility: UCSF Memory and Aging Center
state: California
city: Santa Ana
country: United States
facility: Apex Research Institute
state: California
city: Santa Rosa
country: United States
facility: St Joseph Heritage Healthcare
state: California
city: Sebastopol
country: United States
facility: North Bay Neuroscience Research Institute
state: California
city: Centennial
country: United States
facility: ImmunoE Research Center
state: Colorado
city: Denver
country: United States
facility: Mile High Research Center
state: Colorado
city: Fairfield
country: United States
facility: Associated Neurologists of Southern Connecticut
state: Connecticut
city: New Haven
country: United States
facility: Institute for Neurodegenerative Disorders
state: Connecticut
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Research Center for Clinical Studies, Inc.
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
city: Atlantis
country: United States
facility: JEM Research Institute
state: Florida
city: Bradenton
country: United States
facility: Bradenton Research Center, Inc.
state: Florida
city: Coral Gables
country: United States
facility: Advanced Clinical Research Network
state: Florida
city: Coral Gables
country: United States
facility: Linfritz Research Institute, Inc.
state: Florida
city: Delray Beach
country: United States
facility: Brain Matters Research
state: Florida
city: Fort Myers
country: United States
facility: Neuropsychiatric Research Center of Southwest FL
state: Florida
city: Hollywood
country: United States
facility: Infinity Clinical Research
state: Florida
city: Lady Lake
country: United States
facility: Charter Research
state: Florida
city: Lake Worth
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Maitland
country: United States
facility: Clincloud, LLC
state: Florida
city: Miami Springs
country: United States
facility: Galiz Research
state: Florida
city: Miami
country: United States
facility: Gonzalez MD & Aswad MD Health Services
state: Florida
city: Miami
country: United States
facility: BioMed Research Institute
state: Florida
city: Miami
country: United States
facility: Finlay Medical Research
state: Florida
city: Miami
country: United States
facility: CCM Clinical Research Group
state: Florida
city: Miami
country: United States
facility: Rios Medical Center, Inc.
state: Florida
city: Miami
country: United States
facility: Vitae Research Center
state: Florida
city: Miami
country: United States
facility: Miami Jewish Health Systems
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Miami
country: United States
facility: Allied Biomedical Research (Clinical Trial)
state: Florida
city: Miami
country: United States
facility: Pharmax Research of South Florida, Inc
state: Florida
city: Miami
country: United States
facility: Visionary Investigators Network
state: Florida
city: Ocala
country: United States
facility: Renstar Medical Research
state: Florida
city: Orlando
country: United States
facility: Bioclinica Research
state: Florida
city: Ormond Beach
country: United States
facility: Neurology Associates of Ormond Beach
state: Florida
city: Palm Beach Gardens
country: United States
facility: Advanced Research Consultants, Inc.
state: Florida
city: Palmetto Bay
country: United States
facility: IMIC, Inc.
state: Florida
city: Pompano Beach
country: United States
facility: Quantum Laboratories Inc.
state: Florida
city: Port Charlotte
country: United States
facility: Neurostudies, Inc.
state: Florida
city: Port Orange
country: United States
facility: Progressive Medical Research
state: Florida
city: Stuart
country: United States
facility: Alzheimer's Research and Treatment Center
state: Florida
city: Sunrise
country: United States
facility: Infinity Clinical Research, LLC
state: Florida
city: Tampa
country: United States
facility: Stedman Clinical Trials, LLC
state: Florida
city: Tampa
country: United States
facility: USF Suncoast Gerontology Center
state: Florida
city: The Villages
country: United States
facility: Bioclinica Research
state: Florida
city: West Palm Beach
country: United States
facility: Premiere Research Institute, West Palm
state: Florida
city: Atlanta
country: United States
facility: Emory University Cognitive Neurology Clinic & ADRC
state: Georgia
city: Columbus
country: United States
facility: Columbus Memory Center
state: Georgia
city: Decatur
country: United States
facility: iResearch Atlanta, LLC
state: Georgia
city: Decatur
country: United States
facility: NeuroStudies.net, LLC
state: Georgia
city: Honolulu
country: United States
facility: Hawaii Pacific Neuroscience
state: Hawaii
city: Chicago
country: United States
facility: Great Lakes Clinical Trials
state: Illinois
city: Park Ridge
country: United States
facility: Advocate Lutheran General Hospital
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Neurological Center
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Kansas City
country: United States
facility: University of Kansas Medical Center Research Institute
state: Kansas
city: Wichita
country: United States
facility: KU Wichita Center for Clinical Research
state: Kansas
city: Belmont
country: United States
facility: Partners Population Health
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Methuen
country: United States
facility: ActivMed Practices & Research
state: Massachusetts
city: Newton
country: United States
facility: Boston Center for Memory
state: Massachusetts
city: Plymouth
country: United States
facility: Donald S. Marks, MD. P.C.
state: Massachusetts
city: Hattiesburg
country: United States
facility: Hattiesburg Clinic
state: Mississippi
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo Center for Brain Health
state: Nevada
city: Las Vegas
country: United States
facility: Las Vegas Medical Research
state: Nevada
city: Toms River
country: United States
facility: Advanced Memory Research Institute of NJ, PC
state: New Jersey
city: Toms River
country: United States
facility: Bio Behavioral Health
state: New Jersey
city: Albany
country: United States
facility: Albany Medical College
state: New York
city: Albany
country: United States
facility: Neurological Associates of Albany, PC
state: New York
city: New York
country: United States
facility: New York University Medical Center PRIME
state: New York
city: New York
country: United States
facility: Neurological Institute of New York
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Charlotte
country: United States
facility: ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Neurology Associates, P.A. - Research Department
state: North Carolina
city: Winston-Salem
country: United States
facility: PMG Research of Winston Salem
state: North Carolina
city: Canton
country: United States
facility: OH Clinical Research Partners
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Columbs Neuroscience, LLC
state: Ohio
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
city: Oklahoma City
country: United States
facility: Lynn Health Science Institute
state: Oklahoma
city: Portland
country: United States
facility: Summit Research Network (OR) Inc.
state: Oregon
city: Portland
country: United States
facility: Neural Net Research, LLC
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Norristown
country: United States
facility: Keystone Clinical Studies, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: East Providence
country: United States
facility: Rhode Island Mood & Memory Research Institute
state: Rhode Island
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Providence
country: United States
facility: Butler Hospital - Memory and Aging Program
state: Rhode Island
city: North Charleston
country: United States
facility: Roper St. Francis Healthcare
state: South Carolina
city: Port Royal
country: United States
facility: Coastal Neurology, P.A.
state: South Carolina
city: Cordova
country: United States
facility: Neurology Clinic, P.C.
state: Tennessee
city: Knoxville
country: United States
facility: Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company
state: Tennessee
city: Austin
country: United States
facility: Senior Adult Specialty Research
state: Texas
city: Dallas
country: United States
facility: Texas Neurology, PA
state: Texas
city: Dallas
country: United States
facility: Kerwin Research Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine AD and Memory Disorders Center
state: Texas
city: Houston
country: United States
facility: Clinical Trial Network
state: Texas
city: Bennington
country: United States
facility: DBA The Memory Clinic
state: Vermont
city: Richmond
country: United States
facility: National Clinical Research Inc.-Richmond
state: Virginia
city: Spokane
country: United States
facility: Kingfisher Cooperative LLC
state: Washington
city: Darlinghurst
country: Australia
facility: St Vincent's Hospital - Translational Research Centre
state: New South Wales
city: Macquarie Park
country: Australia
facility: KaRa Institute of Neurological Diseases
state: New South Wales
city: Chermside Brisbane
country: Australia
facility: The Prince Charles Hospital/Internal Medicine & Dementia Research Unit
state: Queensland
city: Woodville South, Adelaid
country: Australia
facility: Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital
state: South Australia
city: Ivanhoe
country: Australia
facility: Austin Health - Medical and Cognitive Research Unit
state: Victoria
city: Malvern
country: Australia
facility: HammondCare Malvern Clinical Trials Unit
state: Victoria
city: Nedlands
country: Australia
facility: Australian Alzheimer's Research Foundation
state: Western Australia
city: Kelowna
country: Canada
facility: Okanagan Clinical Trials
state: British Columbia
city: West Vancouver
country: Canada
facility: Health Research
state: British Columbia
city: Halifax
country: Canada
facility: True North Clinical Research Halifax, Inc.
state: Nova Scotia
city: Kentville
country: Canada
facility: True North Clinical Research Kentville, Inc.
state: Nova Scotia
city: London
country: Canada
facility: St. Joseph's HC- Parkwood Institute
state: Ontario
city: Ottawa
country: Canada
facility: Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic
state: Ontario
city: Peterborough
country: Canada
facility: Kawartha Centre - Redefining Healthy Aging
state: Ontario
city: Toronto
country: Canada
facility: Toronto Memory Program (Neurology Research Inc.)
state: Ontario
city: Gatineau
country: Canada
facility: Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais
state: Quebec
city: Greenfield Park
country: Canada
facility: MoCA Clinic and Institute/NeuroSearch Developpements Inc.
state: Quebec
city: Sherbrooke
country: Canada
facility: Q&T Research Sherbrooke Inc.
state: Quebec
city: Beijing
country: China
facility: Beijing Friendship Hospital, Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Xuanwu Hospital Capital Medical University
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital, Capital Medical University
state: Beijing
city: Guangzhou
country: China
facility: Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou First People's Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangzhou Huiai Hospital
state: Guangdong
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangzhou
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Changsha
country: China
facility: Xiangya Hospital Central South University
state: Hunan
city: Baotou
country: China
facility: Baotou Central Hospital
state: Inner Mongolia Autonomous Region
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Brain Hospital, Affiliated to Nanjing Medical University
state: Jiangsu
city: Changchun
country: China
facility: The First Bethune Hospital of Jilin University
state: Jilin
city: Xining
country: China
facility: Qinghai Provincial People's Hospital
state: Qinghai
city: Jinan
country: China
facility: Jinan Central Hospital
state: Shandong
city: Shanghai
country: China
facility: Shanghai Tongji Hospital
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital Shanghai Jiaotong Universtiy School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Shanghai Sixth People's Hospital
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Huanhu Hospital
state: Tianjin
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Strasbourg Cedex
country: France
facility: Hôpital de Hautepierre
state: Bas Rhin
city: Marseille
country: France
facility: Hopital de la Timone
state: Cedex 05
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
state: Cedex 5
city: Nantes
country: France
facility: Hopital Guillaume et RenÃ LaÃnnec
state: Cedex
city: Paris
country: France
facility: Groupe Hospitalier Pitie-Salpetriere
state: Cedex
city: Toulouse
country: France
facility: Centre de Recherche Clinique du Gérontopôle
state: Haute Garonne
city: Paris cedex 10
country: France
facility: Hôpital Lariboisière
state: Paris
city: Bron Cedex
country: France
facility: Hôpital neurologique Pierre Wertheimer
city: Günzburg
country: Germany
facility: Eisai Trial Site #5
state: Baden Wuerttemberg
city: Mannheim
country: Germany
facility: Eisai Trial Site #2
state: Baden-Wurttemberg
city: Berlin
country: Germany
facility: Eisai Trial Site #6
city: Bielefeld
country: Germany
facility: Eisai Trial Site #1
city: Erbach
country: Germany
facility: Eisai Trial Site #4
city: Munchen
country: Germany
facility: Eisai Trial Site #3
city: Tricase
country: Italy
facility: Ospedale "Card. G. Panico" -
state: LE
city: Cefalu
country: Italy
facility: Fondazione Istituto G.Giglio di Cefalù
state: Palermo
city: Genova
country: Italy
facility: Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova
city: Milano
country: Italy
facility: Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative
city: Monza
country: Italy
facility: ASST-Monza, Ospedale San Gerardo
city: Napoli
country: Italy
facility: Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli"
city: Perugia
country: Italy
facility: Ospedale S. Maria della Misericordia, S. Andrea delle Fratte
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana
city: Roma
country: Italy
facility: Fondazione Policlinico Agostino Gemelli - UCSC
city: Roma
country: Italy
facility: Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane
city: Obu-shi
country: Japan
facility: Eisai Trial Site #4
state: Aichi
city: Chiba-shi
country: Japan
facility: Eisai Trial Site #15
state: Chiba
city: Yoshida-gun
country: Japan
facility: Eisai Trial Site #6
state: Fukui
city: Fujioka-shi
country: Japan
facility: Eisai Trial Site #1
state: Gunma
city: Otake
country: Japan
facility: Eisai Trial Site #32
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Eisai Trial Site #30
state: Hokkaido
city: Himeji-shi
country: Japan
facility: Eisai Trial Site #28
state: Hyogo
city: Kobe-shi
country: Japan
facility: Eisai Trial Site #19
state: Hyogo
city: Toride-shi
country: Japan
facility: Eisai Trial Site #24
state: Ibaraki
city: Kahoku
country: Japan
facility: Eisai Trial Site #9
state: Ishikawa
city: Atsugi-shi
country: Japan
facility: Eisai Trial Site #7
state: Kanagawa
city: Fujisawa-shi
country: Japan
facility: Eisai Trial Site #17
state: Kanagawa
city: Kawasaki-shi
country: Japan
facility: Eisai Trial Site #20
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Eisai Trial Site #2
state: Kanagawa
city: Higashimorokatagun
country: Japan
facility: Eisai Trial Site #33
state: Miyazaki
city: Niigata-shi
country: Japan
facility: Eisai Trial Site #22
state: Niigata
city: Kurashiki-shi
country: Japan
facility: Eisai Trial Site #16
state: Okayama
city: Hirakata
country: Japan
facility: Eisai Trial Site #8
state: Osaka
city: Suita-shi
country: Japan
facility: Eisai Trial Site #26
state: Osaka
city: Saitama-shi
country: Japan
facility: Eisai Trial Site #18
state: Saitama
city: Otsu-shi
country: Japan
facility: Eisai Trial Site #31
state: Shiga
city: Bunkyo-ku
country: Japan
facility: Eisai Trial Site #5
state: Tokyo
city: Bunkyo-ku
country: Japan
facility: Eisai Trial Site #29
state: Tokyo
city: Hachioji-shi
country: Japan
facility: Eisai Trial Site #13
state: Tokyo
city: Musashino-shi
country: Japan
facility: Eisai Trial Site #12
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Eisai Trial Site #23
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Eisai Trial Site #25
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Eisai Trial Site #10
state: Tokyo
city: Yamagata-shi
country: Japan
facility: Eisai Trial Site #3
state: Yamagata
city: Hofu
country: Japan
facility: Eisai Trial Site #21
state: Yamaguchi
city: Ube-shi
country: Japan
facility: Eisai Trial Site #14
state: Yamaguchi
city: Osaka
country: Japan
facility: Eisai Trial Site #11
city: Osaka
country: Japan
facility: Eisai Trial Site #27
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
state: Jeolla-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Seoul
city: Busan
country: Korea, Republic of
facility: Dong-A University Hospital
city: Incheon
country: Korea, Republic of
facility: Inha University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Konkuk University Medical Center
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Seoul ST. Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Boramae Medical Center
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M. Sechenov
city: Singapore
country: Singapore
facility: National University Hospital
city: Sant Cugat del Valles
country: Spain
facility: Hospital General de Catalunya
state: Barcelona
city: Getxo
country: Spain
facility: Centro CAE Oroitu
state: Bizkaia
city: Donostia San Sebastian
country: Spain
facility: Fundación CITA-alzheimer Findazioa
state: Gipuzkoa
city: San Sebastian
country: Spain
facility: Policlinica Guipuzcoa
state: Guipuzcoa
city: Barcelona
country: Spain
facility: Fundacion ACE, Barcelona
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Santa Cruz y San Pablo
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Complejo Hospitalario Ruber Juan Bravo
city: Salamanca
country: Spain
facility: Hospital de Salamanca
city: Sevilla
country: Spain
facility: Hospital Victoria Eugenia - Cruz Roja
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic La Fe
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
state: Västra Götalandslän
city: Malmö
country: Sweden
facility: Memory Clinic, Malmö University Hospital
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital, Uppsala
city: Plymouth
country: United Kingdom
facility: Re:Cognition Health
state: Devon
city: Southampton
country: United Kingdom
facility: Memory Assessment & Research Centre (MARC),
state: Hampshire
city: Sheffield
country: United Kingdom
facility: Sheffield Memory Service
state: South Yorkshire
city: Birmingham
country: United Kingdom
facility: Re:Cognition Health Ltd
city: Guildford
country: United Kingdom
facility: Re:Cognition Health Ltd
city: London
country: United Kingdom
facility: St. Pancras Clinical Research
city: London
country: United Kingdom
facility: Re:Cognition Health Ltd
city: London
country: United Kingdom
facility: Charing Cross Hospital
Study officials:
References: