Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Confirm Safety and Efficacy of BAN2401 in Participants With Early Alzheimer's Disease (Clarity AD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03887455
Recruitment Status : Recruiting
First Posted : March 25, 2019
Last Update Posted : October 23, 2020
Sponsor:
Collaborator:
Biogen
Information provided by (Responsible Party):
Eisai Inc.

Brief Summary:
This study will be conducted to evaluate the efficacy of BAN2401 in participants with early Alzheimer's disease (EAD) by determining the superiority of BAN2401 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 BAN2401 in participants with EAD in the Extension Phase and whether the long-term effects of BAN2401 as measured by the CDR-SB at the end of the Core Study is maintained over time in the Extension Phase.

Condition or disease Intervention/treatment Phase
Early Alzheimer's Disease Drug: BAN2401 Drug: Placebo Phase 3

Detailed Description:
All infusion will be administered in the clinic; However, home infusions will be allowed per sponsor approval according to country and local guidelines during the COVID-19 pandemic and following its resolution, where permitted.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1566 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : March 27, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : August 29, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Core Study: BAN2401 10 mg/kg biweekly Drug: BAN2401
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.

Placebo Comparator: Core Study: Placebo Drug: Placebo
Biweekly (once every 2 weeks) administered i.v. infusion.

Experimental: Extension Phase: BAN2401 10 mg/kg biweekly Drug: BAN2401
10 mg/kg biweekly (once every 2 weeks) administered as i.v. infusion.




Primary Outcome Measures :
  1. Core Study: Change from Baseline in the CDR-SB at 18 Months [ Time Frame: Baseline, 18 months ]
  2. Extension Phase: Number of Participants With Adverse Events (AEs), Clinically Significant Change From Baseline in Vital Signs Values, Abnormal MRI and ECG Values, Clinically Significant Findings in Laboratory Values, Positive ADAs, and any Suicidality [ Time Frame: Month 18 up to Month 45 ]
    Here MRI means magnetic resonance imaging, ECG means electrocardiogram, and ADAs means antidrug antibodies.

  3. Extension Phase: Change from Core Study Baseline in CDR-SB [ Time Frame: Baseline up to Month 45 ]

Secondary Outcome Measures :
  1. Core Study: Change from Baseline in the Amyloid Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVR) Composite at 18 Months [ Time Frame: Baseline, 18 months ]
  2. Core Study: Change from Baseline in Alzheimer's Disease Composite Score (ADCOMS) at 18 Months [ Time Frame: Baseline, 18 months ]
  3. Core Study: Change from Baseline in Alzheimer Disease Assessment Scale - Cognitive Subscale 14 (ADAS-cog14) at 18 Months [ Time Frame: Baseline, 18 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • Have a BMI >17 and <35
  • 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

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 BAN2401
  • Participants who were dosed in a clinical study involving any new chemical entities for Alzheimer's disease (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

    • TIA, stroke, or seizures
    • 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 (however, lesions diagnosed as meningiomas or arachnoid cysts and <1 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
    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03887455


Contacts
Layout table for location contacts
Contact: Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

Locations
Hide Hide 250 study locations
Layout table for location information
United States, Arizona
Banner Alzheimer's Institute- Clinical Trials Department Recruiting
Phoenix, Arizona, United States, 85006
Barrow Neurological Institute Not yet recruiting
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Recruiting
Sun City, Arizona, United States, 85351
Neurological Associates of Tucson dba Center for Neurosciences Recruiting
Tucson, Arizona, United States, 85718
United States, California
Neurology Center of North Orange County Recruiting
Fullerton, California, United States, 92835
Irvine Clinical Research Recruiting
Irvine, California, United States, 92614
University of California - Los Angeles Not yet recruiting
Los Angeles, California, United States, 90045
Pacific Neuroscience Medical Group Recruiting
Oxnard, California, United States, 93030
Stanford University Medical Center Not yet recruiting
Palo Alto, California, United States, 94304
Pacific Research Network, Inc Recruiting
San Diego, California, United States, 92103
Sharp Mesa Vista Hospital Recruiting
San Diego, California, United States, 92123
UCSF Memory and Aging Center Recruiting
San Francisco, California, United States, 94158
Apex Research Institute Recruiting
Santa Ana, California, United States, 92705
St Joseph Heritage Healthcare Recruiting
Santa Rosa, California, United States, 95403
North Bay Neuroscience Research Institute Recruiting
Sebastopol, California, United States, 95472
United States, Colorado
Mile High Research Center Not yet recruiting
Denver, Colorado, United States, 80218
United States, Connecticut
Associated Neurologists of Southern Connecticut Not yet recruiting
Fairfield, Connecticut, United States, 06824
Institute for Neurodegenerative Disorders Not yet recruiting
New Haven, Connecticut, United States, 06510
Yale University School Of Medicine Recruiting
New Haven, Connecticut, United States, 06510
Research Center for Clinical Studies, Inc. Recruiting
Norwalk, Connecticut, United States, 06851
United States, District of Columbia
Georgetown University Hospital Recruiting
Washington, District of Columbia, United States, 20057
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Bradenton Research Center, Inc. Recruiting
Bradenton, Florida, United States, 34205
Advanced Clinical Research Network Recruiting
Coral Gables, Florida, United States, 33134
Linfritz Research Institute, Inc. Not yet recruiting
Coral Gables, Florida, United States, 33134
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research Center of Southwest FL Recruiting
Fort Myers, Florida, United States, 33912
Infinity Clinical Research Recruiting
Hollywood, Florida, United States, 33024
Charter Research Recruiting
Lady Lake, Florida, United States, 32159
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Galiz Research Recruiting
Miami Springs, Florida, United States, 33016
BioMed Research Institute Recruiting
Miami, Florida, United States, 33126
Finlay Medical Research Recruiting
Miami, Florida, United States, 33126
CCM Clinical Research Group Recruiting
Miami, Florida, United States, 33133
Rios Medical Center, Inc. Not yet recruiting
Miami, Florida, United States, 33135
Vitae Research Center Recruiting
Miami, Florida, United States, 33135
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Visionary Investigators Network Recruiting
Miami, Florida, United States, 33137
Allied Biomedical Research (Clinical Trial) Recruiting
Miami, Florida, United States, 33155
Visionary Investigators Network Recruiting
Miami, Florida, United States, 33180
Renstar Medical Research Recruiting
Ocala, Florida, United States, 34470
Waypoint Clinical Research, LLC Withdrawn
Ocoee, Florida, United States, 34761
Bioclinica Research Recruiting
Orlando, Florida, United States, 32806
Gutierrez Medical Center/ Research Not yet recruiting
Orlando, Florida, United States, 32807
Neurology Associates of Ormond Beach Recruiting
Ormond Beach, Florida, United States, 32174
Advanced Research Consultants, Inc. Recruiting
Palm Beach Gardens, Florida, United States, 33410
IMIC, Inc. Recruiting
Palmetto Bay, Florida, United States, 33157
Quantum Laboratories Inc. Recruiting
Pompano Beach, Florida, United States, 33064
Neurostudies, Inc. Recruiting
Port Charlotte, Florida, United States, 33952
Progressive Medical Research Recruiting
Port Orange, Florida, United States, 32127
Infinity Clinical Research, LLC Recruiting
Sunrise, Florida, United States, 33351
Stedman Clinical Trials, LLC Recruiting
Tampa, Florida, United States, 33613
USF Suncoast Gerontology Center Not yet recruiting
Tampa, Florida, United States, 33613
Bioclinica Research Recruiting
The Villages, Florida, United States, 32162
Premiere Research Institute, West Palm Recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University Cognitive Neurology Clinic & ADRC Recruiting
Atlanta, Georgia, United States, 30329
Columbus Memory Center Recruiting
Columbus, Georgia, United States, 31909
iResearch Atlanta, LLC Recruiting
Decatur, Georgia, United States, 30030
NeuroStudies.net, LLC Recruiting
Decatur, Georgia, United States, 30033
United States, Hawaii
Hawaii Pacific Neuroscience Recruiting
Honolulu, Hawaii, United States, 96817
United States, Illinois
Advocate Lutheran General Hospital Recruiting
Park Ridge, Illinois, United States, 60068
United States, Indiana
Fort Wayne Neurological Center Recruiting
Fort Wayne, Indiana, United States, 46804
Indiana University School of Medicine Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center Research Institute Not yet recruiting
Kansas City, Kansas, United States, 66160
KU Wichita Center for Clinical Research Recruiting
Wichita, Kansas, United States, 67214
United States, Kentucky
University of Kentucky Medical Center Recruiting
Lexington, Kentucky, United States, 40504
United States, Massachusetts
Partners Population Health Not yet recruiting
Belmont, Massachusetts, United States, 02478
Brigham and Women's Hospital Not yet recruiting
Boston, Massachusetts, United States, 02115
Boston University School of Medicine Not yet recruiting
Boston, Massachusetts, United States, 02118
ActivMed Practices & Research Recruiting
Methuen, Massachusetts, United States, 01844
Boston Center for Memory Recruiting
Newton, Massachusetts, United States, 02459
Donald S. Marks, MD. P.C. Recruiting
Plymouth, Massachusetts, United States, 02360
United States, Mississippi
Hattiesburg Clinic Not yet recruiting
Hattiesburg, Mississippi, United States, 39401
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63108
Millenium Psychiatric Associates, LLC Not yet recruiting
Saint Louis, Missouri, United States, 63132
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health Not yet recruiting
Las Vegas, Nevada, United States, 89106
Las Vegas Medical Research Recruiting
Las Vegas, Nevada, United States, 89113
United States, New Jersey
Advanced Memory Research Institute of NJ, PC Recruiting
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County, PA Recruiting
West Long Branch, New Jersey, United States, 07764
United States, New York
Albany Medical College Recruiting
Albany, New York, United States, 12208
Neurological Associates of Albany, PC Recruiting
Albany, New York, United States, 12208
New York University Medical Center PRIME Recruiting
New York, New York, United States, 10016
Cornell U - Weill Cornell Medicine Not yet recruiting
New York, New York, United States, 10021
Neurological Institute of New York Recruiting
New York, New York, United States, 10032
University of Rochester Recruiting
Rochester, New York, United States, 14620
United States, North Carolina
ANI Neurology, PLLC d/b/a Alzheimer's Memory Center Recruiting
Charlotte, North Carolina, United States, 28270
Raleigh Neurology Associates, P.A. - Research Department Recruiting
Raleigh, North Carolina, United States, 27607
PMG Research of Winston Salem Not yet recruiting
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Insight Clinical Trials, LLC Withdrawn
Beachwood, Ohio, United States, 44122
OH Clinical Research Partners Not yet recruiting
Canton, Ohio, United States, 44718
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44195
Columbs Neuroscience, LLC Recruiting
Columbus, Ohio, United States, 43020
Ohio State University Recruiting
Columbus, Ohio, United States, 43221
United States, Oregon
Summit Research Network (OR) Inc. Recruiting
Portland, Oregon, United States, 97210
Neural Net Research, LLC Recruiting
Portland, Oregon, United States, 97225
Oregon Health & Science University Not yet recruiting
Portland, Oregon, United States, 97239
United States, Pennsylvania
Keystone Clinical Studies, LLC Recruiting
Norristown, Pennsylvania, United States, 19403
University of Pennsylvania Not yet recruiting
Philadelphia, Pennsylvania, United States, 19104
United States, Rhode Island
Rhode Island Mood & Memory Research Institute Recruiting
East Providence, Rhode Island, United States, 02914
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Butler Hospital - Memory and Aging Program Recruiting
Providence, Rhode Island, United States, 02906
United States, South Carolina
Roper St. Francis Healthcare Not yet recruiting
North Charleston, South Carolina, United States, 29406
Coastal Neurology, P.A. Recruiting
Port Royal, South Carolina, United States, 29935
United States, Tennessee
Neurology Clinic, P.C. Recruiting
Cordova, Tennessee, United States, 38018
Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
Senior Adult Specialty Research Recruiting
Austin, Texas, United States, 78757
Texas Neurology, PA Recruiting
Dallas, Texas, United States, 75214
Kerwin Research Center Recruiting
Dallas, Texas, United States, 75231
Baylor College of Medicine AD and Memory Disorders Center Recruiting
Houston, Texas, United States, 77030
Clinical Trial Network Not yet recruiting
Houston, Texas, United States, 77074
United States, Vermont
DBA The Memory Clinic Recruiting
Bennington, Vermont, United States, 05201
United States, Virginia
National Clinical Research Inc.-Richmond Recruiting
Richmond, Virginia, United States, 23294
United States, Washington
Kingfisher Cooperative LLC Recruiting
Spokane, Washington, United States, 99202
Australia, New South Wales
St Vincent's Hospital - Translational Research Centre Not yet recruiting
Darlinghurst, New South Wales, Australia, 2010
NSW Neurodegenerative Clinical Trials (HammondCare) Not yet recruiting
Greenwich, New South Wales, Australia, 2065
KaRa Institute of Neurological Diseases Not yet recruiting
Macquarie Park, New South Wales, Australia, 2229
Australia, Queensland
The Prince Charles Hospital/Internal Medicine & Dementia Research Unit Not yet recruiting
Chermside Brisbane, Queensland, Australia, 4032
Australia, South Australia
Central Adelaide Local Health Network, The Queen Elizabeth Hospital and the Royal Adelaide Hospital Not yet recruiting
Woodville South, Adelaid, South Australia, Australia, 5011
Australia, Victoria
Austin Health - Medical and Cognitive Research Unit Not yet recruiting
Ivanhoe, Victoria, Australia, 3081
HammondCare Malvern Clinical Trials Unit Not yet recruiting
Malvern, Victoria, Australia, 3144
Australia, Western Australia
Australian Alzheimer's Research Foundation Not yet recruiting
Nedlands, Western Australia, Australia, 6009
Canada, British Columbia
Okanagan Clinical Trials Recruiting
Kelowna, British Columbia, Canada, V1Y 1Z9
Health Research Recruiting
West Vancouver, British Columbia, Canada, V7T 1C5
Canada, Nova Scotia
True North Clinical Research Halifax, Inc. Recruiting
Halifax, Nova Scotia, Canada, B3S 1M7
True North Clinical Research Kentville, Inc. Recruiting
Kentville, Nova Scotia, Canada, B4N 4K9
Canada, Ontario
St. Joseph's HC- Parkwood Institute Recruiting
London, Ontario, Canada, N6C 0A7
Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic Recruiting
Ottawa, Ontario, Canada, K1Z 1G3
Kawartha Centre - Redefining Healthy Aging Recruiting
Peterborough, Ontario, Canada, K9H 2P4
Toronto Memory Program (Neurology Research Inc.) Recruiting
Toronto, Ontario, Canada, M3B 2S7
Canada, Quebec
Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais Recruiting
Gatineau, Quebec, Canada, J8T 8JI
MoCA Clinic and Institute/NeuroSearch Developpements Inc. Recruiting
Greenfield Park, Quebec, Canada, J4V 2J2
Q&T Research Sherbrooke Inc. Recruiting
Sherbrooke, Quebec, Canada, J1J 2G2
Canada
CHU de Quebec - Hôpital de l' Enfant Jésus Not yet recruiting
Quebec, Canada
China, Beijing
Beijing Friendship Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100050
Xuanwu Hospital Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100053
Beijing Tiantan Hospital, Capital Medical University Not yet recruiting
Beijing, Beijing, China, 100070
China, Guangdong
Sun Yat-Sent Memorial Hospital of Sun Yat-Sen University Not yet recruiting
Guangzhou, Guangdong, China, 510120
Guangzhou First People's Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510180
Guangzhou Huiai Hospital Not yet recruiting
Guangzhou, Guangdong, China, 510450
China, Guangzhou
Guangdong Provincial People's Hospital Not yet recruiting
Guangzhou, Guangzhou, China, 510080
China, Hebei
The Second Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China, 50000
China, Henan
Henan Provincial People's Hospital Not yet recruiting
Zhengzhou, Henan, China, 450003
China, Hunan
Xiangya Hospital Central South University Not yet recruiting
Changsha, Hunan, China, 410008
China, Inner Mongolia Autonomous Region
Baotou Central Hospital Not yet recruiting
Baotou, Inner Mongolia Autonomous Region, China, 014040
China, Jiangsu
Nanjing Drum Tower Hospital Not yet recruiting
Nanjing, Jiangsu, China, 210008
Nanjing Brain Hospital, Affiliated to Nanjing Medical University Not yet recruiting
Nanjing, Jiangsu, China, 210029
China, Jilin
The First Bethune Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China, 130000
China, Qinghai
Qinghai Provincial People's Hospital Not yet recruiting
Xining, Qinghai, China, 810007
China, Shandong
Jinan Central Hospital Not yet recruiting
Jinan, Shandong, China, 250013
China, Shanghai
Shanghai Tongji Hospital Not yet recruiting
Shanghai, Shanghai, China, 200065
Renji Hospital Shanghai Jiaotong Universtiy School of Medicine Not yet recruiting
Shanghai, Shanghai, China, 200215
China, Tianjin
Tianjin Huanhu Hospital Not yet recruiting
Tianjin, Tianjin, China, 300350
China, Zhejiang
Sir Run Run Shaw Hospital, Zhejiang University School of Medicine Not yet recruiting
Hangzhou, Zhejiang, China, 310016
France
Hôpital de Hautepierre Recruiting
Strasbourg Cedex, Bas Rhin, France, 67200
Hopital de la Timone Recruiting
Marseille, Cedex 05, France, 13385
Hôpital Gui de Chauliac Recruiting
Montpellier, Cedex 5, France, 34295
Hopital Guillaume et Renà LaÃnnec Recruiting
Nantes, Cedex, France, 44093
Groupe Hospitalier Pitie-Salpetriere Recruiting
Paris, Cedex, France, 75013
Centre de Recherche Clinique du Gérontopôle Recruiting
Toulouse, Haute Garonne, France, 31059
Hôpital Lariboisière Recruiting
Paris cedex 10, Paris, France, 75010
Hôpital neurologique Pierre Wertheimer Recruiting
Bron Cedex, France, 69500
Germany
Eisai Trial Site #5 Not yet recruiting
Günzburg, Baden Wuerttemberg, Germany, 89312
Eisai Trial Site #2 Recruiting
Mannheim, Baden-Wurttemberg, Germany, D-68159
Eisai Trial Site #6 Not yet recruiting
Berlin, Germany, 12203
Eisai Trial Site #1 Recruiting
Bielefeld, Germany, 33647
Eisai Trial Site #4 Recruiting
Erbach, Germany, 64711
Eisai Trial Site #7 Not yet recruiting
Essen, Germany, 45356
Eisai Trial Site #3 Recruiting
Munchen, Germany, 81675
Italy
Ospedale "Card. G. Panico" - Recruiting
Tricase, LE, Italy, 73039
Fondazione Istituto G.Giglio di Cefalù Recruiting
Cefalu, Palermo, Italy, 90015
Clinica Neurologica, IRCCS Ospedale Policlinico San Martino, Genova Recruiting
Genova, Italy, 16132
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico - U.O.S.D. Malattie Neurodegenerative Recruiting
Milano, Italy, 20122
ASST-Monza, Ospedale San Gerardo Recruiting
Monza, Italy, 20900
Prima Clinica Neurologica, Primo Policlinico AOU "L. Vanvitelli" Not yet recruiting
Napoli, Italy, 80138
Ospedale S. Maria della Misericordia, S. Andrea delle Fratte Recruiting
Perugia, Italy, 06132
Azienda Ospedaliero Universitaria Pisana Not yet recruiting
Pisa, Italy, 56126
Fondazione Policlinico Agostino Gemelli - UCSC Recruiting
Roma, Italy, 00168
Universita' Sapienza di Roma - Dipartimento di Neuroscienze Umane Recruiting
Roma, Italy, 00185
Japan
Eisai Trial Site #4 Recruiting
Obu-shi, Aichi, Japan, 4748511
Eisai Trial Site #15 Recruiting
Chiba-shi, Chiba, Japan, 260-8656
Eisai Trial Site #6 Recruiting
Yoshida-gun, Fukui, Japan, 9101193
Eisai Trial Site #1 Recruiting
Fujioka-shi, Gunma, Japan, 3750017
Eisai Trial Site #32 Recruiting
Otake, Hiroshima, Japan, 7390696
Eisai Trial Site #30 Recruiting
Sapporo-shi, Hokkaido, Japan, 650033
Eisai Trial Site #28 Recruiting
Himeji-shi, Hyogo, Japan, 6700981
Eisai Trial Site #19 Recruiting
Kobe-shi, Hyogo, Japan, 6500017
Eisai Trial Site #24 Recruiting
Toride-shi, Ibaraki, Japan, 302-0004
Eisai Trial Site #9 Recruiting
Kahoku, Ishikawa, Japan, 920-0293
Eisai Trial Site #7 Recruiting
Atsugi-shi, Kanagawa, Japan, 2438551
Eisai Trial Site #17 Recruiting
Fujisawa-shi, Kanagawa, Japan, 2510038
Eisai Trial Site #20 Recruiting
Kawasaki-shi, Kanagawa, Japan, 2118533
Eisai Trial Site #2 Recruiting
Yokohama-shi, Kanagawa, Japan, 2350012
Eisai Trial Site #33 Recruiting
Higashimorokatagun, Miyazaki, Japan, 880-1111
Eisai Trial Site #22 Recruiting
Niigata-shi, Niigata, Japan, 9500983
Eisai Trial Site #16 Recruiting
Kurashiki-shi, Okayama, Japan, 7100813
Eisai Trial Site #8 Recruiting
Hirakata, Osaka, Japan, 5731121
Eisai Trial Site #26 Recruiting
Suita-shi, Osaka, Japan, 565-0871
Eisai Trial Site #18 Recruiting
Saitama-shi, Saitama, Japan, 338-8577
Eisai Trial Site #31 Recruiting
Otsu-shi, Shiga, Japan, 520-2192
Eisai Trial Site #5 Recruiting
Bunkyo-ku, Tokyo, Japan, 113-0034
Eisai Trial Site #29 Recruiting
Bunkyo-ku, Tokyo, Japan, 180-8610
Eisai Trial Site #13 Recruiting
Hachioji-shi, Tokyo, Japan, 193-0998
Eisai Trial Site #12 Recruiting
Musashino-shi, Tokyo, Japan, 180-8610
Eisai Trial Site #23 Recruiting
Shinagawa-ku, Tokyo, Japan, 142-0054
Eisai Trial Site #25 Recruiting
Shinjuku-ku, Tokyo, Japan, 160-0023
Eisai Trial Site #10 Recruiting
Shinjuku-ku, Tokyo, Japan, 160-8582
Eisai Trial Site #3 Recruiting
Yamagata-shi, Yamagata, Japan, 9900834
Eisai Trial Site #21 Recruiting
Hofu, Yamaguchi, Japan, 7470802
Eisai Trial Site #14 Recruiting
Ube-shi, Yamaguchi, Japan, 755-8505
Eisai Trial Site #11 Recruiting
Osaka, Japan, 5458586
Eisai Trial Site #27 Recruiting
Osaka, Japan, 5560017
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
Chonnam National University Hospital Recruiting
Gwangju, Jeolla-do, Korea, Republic of, 61469
Seoul National University Bundang Hospital Recruiting
Seongnam-si, Seoul, Korea, Republic of, 13620
Dong-A University Hospital Recruiting
Busan, Korea, Republic of, 49201
Inha University Hospital Recruiting
Incheon, Korea, Republic of, 22332
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital, Yonsei University Health System Recruiting
Seoul, Korea, Republic of, 03722
Hanyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of, 04763
Konkuk University Medical Center Recruiting
Seoul, Korea, Republic of, 05030
Asan Medical Center Recruiting
Seoul, Korea, Republic of, 05505
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
The Catholic University of Korea, Seoul ST. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Seoul National University Boramae Medical Center Recruiting
Seoul, Korea, Republic of, 07061
Russian Federation
First Moscow State Medical University n.a. I.M. Sechenov Not yet recruiting
Moscow, Russian Federation, 119991
Singapore
National University Hospital Not yet recruiting
Singapore, Singapore, 119228
Spain
Hospital General de Catalunya Recruiting
Sant Cugat del Valles, Barcelona, Spain, 08195
Centro CAE Oroitu Recruiting
Getxo, Bizkaia, Spain, 48993
Fundación CITA-alzheimer Findazioa Recruiting
Donostia San Sebastian, Gipuzkoa, Spain, 20009
Policlinica Guipuzcoa Recruiting
San Sebastian, Guipuzcoa, Spain, 20014
Fundacion ACE, Barcelona Recruiting
Barcelona, Spain, 08028
Hospital Clinic i Provincial de Barcelona Recruiting
Barcelona, Spain, 08036
Hospital Universitario Reina Sofía Recruiting
Cordoba, Spain, 14011
Complejo Hospitalario Ruber Juan Bravo Recruiting
Madrid, Spain, 28006
Hospital de Salamanca Recruiting
Salamanca, Spain, 37005
Hospital Victoria Eugenia - Cruz Roja Recruiting
Sevilla, Spain, 41009
Hospital Universitari i Politècnic La Fe Recruiting
Valencia, Spain, 46026
Sweden
Sahlgrenska University Hospital Not yet recruiting
Gothenburg, Västra Götalandslän, Sweden, 43141
Memory Clinic, Malmö University Hospital Not yet recruiting
Malmö, Sweden, 20502
Karolinska University Hospital Not yet recruiting
Stockholm, Sweden, 141 86
Uppsala University Hospital, Uppsala Not yet recruiting
Uppsala, Sweden, 751 85
United Kingdom
Re:Cognition Health Recruiting
Plymouth, Devon, United Kingdom, PL6 8BT
Memory Assessment & Research Centre (MARC), Recruiting
Southampton, Hampshire, United Kingdom, SO30 3JB
MAC Clinical Research Blackpool Withdrawn
Blackpool, Lancashire, United Kingdom, FY2 0JH
Sheffield Memory Service Recruiting
Sheffield, South Yorkshire, United Kingdom, S5 7JT
Re:Cognition Health Ltd Recruiting
Birmingham, United Kingdom, B16 8LT
Re:Cognition Health Ltd Recruiting
Guildford, United Kingdom, GU2 7YD
St. Pancras Clinical Research Recruiting
London, United Kingdom, EC2Y 8 EA
Re:Cognition Health Ltd Recruiting
London, United Kingdom, W1G 9JF
Charing Cross Hospital Recruiting
London, United Kingdom, W6 8RF
Sponsors and Collaborators
Eisai Inc.
Biogen
Layout table for additonal information
Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT03887455    
Other Study ID Numbers: BAN2401-G000-301
2018-004739-58 ( EudraCT Number )
First Posted: March 25, 2019    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Eisai's data sharing commitment and further information on how to request data can be found on our website http://eisaiclinicaltrials.com/.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Eisai Inc.:
BAN2401
Clinical Dementia Rating-Sum of Boxes
Mild cognitive impairment
Alzheimer's disease/prodromal Alzheimer's disease
Mild Alzheimer's disease dementia
Clarity AD
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders