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BAN2401 for People with Early Alzheimer's Disease (Clarity AD)

Recruiting

This Phase III trial will test the effectiveness of the experimental drug BAN2401 as a possible treatment for Alzheimer's disease. 

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 90 Years All No
March 29, 2019
July 3, 2024
1566

Participants with Mild Cognitive Impairment (MCI) Due to Alzheimer's Disease

  • Meet the National Institute of Aging-Alzheimer's Association (NIA-AA) core clinical criteria for intermediate likelihood of MCI due to Alzheimer's
  • Have a global Clinical Dementia Rating (CDR) score of 0.5 and CDR Memory Box score of 0.5 or greater

Participants with Mild Alzheimer's Disease

  • Meet the NIA-AA core clinical criteria for probable Alzheimer's disease dementia and have a global CDR score of 0.5 to 1 and a CDR Memory Box score of 0.5 or greater

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 II
  • Positive measure of brain amyloid pathology
  • Mini-Mental State Examination score of 22 to 30
  • Body mass index of 17 to 35
  • If taking Alzheimer's medications, including acetylcholinesterase inhibitors and/or memantine, must be on a stable dose for at least 12 weeks
  • Must have been on stable doses of all other permitted medications for at least 4 weeks

  • Any neurological condition other than Alzheimer's disease that may be contributing to cognitive impairment
  • History of transient ischemic attacks, stroke, or seizures within past year
  • Any psychiatric diagnosis or symptoms, such as hallucinations, major depression, or delusions, that could interfere with study
  • Geriatric Depression Scale score of 8 or greater
  • Inability to undergo magnetic resonance imaging (MRI), including cardiac pacemaker/defibrillator and metal implants
  • Evidence of other significant lesions on brain MRI that could indicate a dementia diagnosis other than Alzheimer's disease
  • Any other unstable or not adequately controlled medical condition, such as cardiac, respiratory, gastrointestinal, or liver disease, or conditions that could affect participant safety or interfere with study assessments
  • Prior exposure to BAN2401

BAN2401 is a monoclonal antibody that binds to large oligomers, called protofibrils, and neutralizes their damage to brain cells. This 18-month study will test the effectiveness of the study drug in people with MCI or early Alzheimer's disease. Participants will be randomly assigned to an intravenous infusion of either the study drug or a placebo every two weeks for 18 months.

For more information on this trial, contact Eisai Medical Information at 888-274-2378 or esi_medinfo@eisai.com.

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute- Clinical Trials Department
Phoenix Arizona 85006 Recruiting

Barrow Neurological Institute
Phoenix Arizona 85013 Not yet recruiting

Banner Sun Health Research
Sun City Arizona 85351 Recruiting

Neurological Associates of Tucson dba Center for Neurosciences
Tucson Arizona 85718 Recruiting

Neurology Center of North Orange County
Fullerton California 92835 Recruiting

Irvine Clinical Research
Irvine California 92614 Recruiting

University of California - Los Angeles
Los Angeles California 90045 Not yet recruiting

Pacific Neuroscience Medical Group
Oxnard California 93030 Recruiting

Stanford University Medical Center
Palo Alto California 94304 Not yet recruiting

Pacific Research Network, Inc
San Diego California 92103 Recruiting

Sharp Mesa Vista Hospital
San Diego California 92123 Recruiting

UCSF Memory and Aging Center
San Francisco California 94158 Recruiting

Apex Research Institute
Santa Ana California 92705 Recruiting

St Joseph Heritage Healthcare
Santa Rosa California 95403 Recruiting

North Bay Neuroscience Research Institute
Sebastopol California 95472 Recruiting

Mile High Research Center
Denver Colorado 80218 Not yet recruiting

Associated Neurologists of Southern Connecticut
Fairfield Connecticut 06824 Not yet recruiting

Institute for Neurodegenerative Disorders
New Haven Connecticut 06510 Not yet recruiting

Yale University School Of Medicine
New Haven Connecticut 06510 Recruiting

Research Center for Clinical Studies, Inc.
Norwalk Connecticut 06851 Recruiting

Georgetown University Hospital
Washington District of Columbia 20057 Recruiting

JEM Research Institute
Atlantis Florida 33462 Recruiting

Bradenton Research Center, Inc.
Bradenton Florida 34205 Recruiting

Advanced Clinical Research Network
Coral Gables Florida 33134 Recruiting

Linfritz Research Institute, Inc.
Coral Gables Florida 33134 Not yet recruiting

Brain Matters Research
Delray Beach Florida 33445 Recruiting

Neuropsychiatric Research Center of Southwest FL
Fort Myers Florida 33912 Recruiting

Infinity Clinical Research
Hollywood Florida 33024 Recruiting

Charter Research
Lady Lake Florida 32159 Recruiting

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449 Recruiting

BioMed Research Institute
Miami Florida 33126 Recruiting

Finlay Medical Research
Miami Florida 33126 Recruiting

CCM Clinical Research Group
Miami Florida 33133 Recruiting

Rios Medical Center, Inc.
Miami Florida 33135 Not yet recruiting

Vitae Research Center
Miami Florida 33135 Recruiting

Miami Jewish Health Systems
Miami Florida 33137 Recruiting

Visionary Investigators Network
Miami Florida 33137 Recruiting

Allied Biomedical Research (Clinical Trial)
Miami Florida 33155 Recruiting

Visionary Investigators Network
Miami Florida 33180 Recruiting

Galiz Research
Miami Springs Florida 33016 Recruiting

Renstar Medical Research
Ocala Florida 34470 Recruiting

Waypoint Clinical Research, LLC
Ocoee Florida 34761 Withdrawn

Bioclinica Research
Orlando Florida 32806 Recruiting

Gutierrez Medical Center/ Research
Orlando Florida 32807 Not yet recruiting

Neurology Associates of Ormond Beach
Ormond Beach Florida 32174 Recruiting

Advanced Research Consultants, Inc.
Palm Beach Gardens Florida 33410 Recruiting

IMIC, Inc.
Palmetto Bay Florida 33157 Recruiting

Quantum Laboratories Inc.
Pompano Beach Florida 33064 Recruiting

Neurostudies, Inc.
Port Charlotte Florida 33952 Recruiting

Progressive Medical Research
Port Orange Florida 32127 Recruiting

Infinity Clinical Research, LLC
Sunrise Florida 33351 Recruiting

Stedman Clinical Trials, LLC
Tampa Florida 33613 Recruiting

USF Suncoast Gerontology Center
Tampa Florida 33613 Not yet recruiting

Bioclinica Research
The Villages Florida 32162 Recruiting

Premiere Research Institute, West Palm
West Palm Beach Florida 33407 Recruiting

Emory University Cognitive Neurology Clinic & ADRC
Atlanta Georgia 30329 Recruiting

Columbus Memory Center
Columbus Georgia 31909 Recruiting

iResearch Atlanta, LLC
Decatur Georgia 30030 Recruiting

NeuroStudies.net, LLC
Decatur Georgia 30033 Recruiting

Hawaii Pacific Neuroscience
Honolulu Hawaii 96817 Recruiting

Advocate Lutheran General Hospital
Park Ridge Illinois 60068 Recruiting

Fort Wayne Neurological Center
Fort Wayne Indiana 46804 Recruiting

Indiana University School of Medicine
Indianapolis Indiana 46202 Recruiting

University of Kansas Medical Center Research Institute
Kansas City Kansas 66160 Not yet recruiting

KU Wichita Center for Clinical Research
Wichita Kansas 67214 Recruiting

University of Kentucky Medical Center
Lexington Kentucky 40504 Recruiting

Partners Population Health
Belmont Massachusetts 02478 Not yet recruiting

Brigham and Women's Hospital
Boston Massachusetts 02115 Not yet recruiting

Boston University School of Medicine
Boston Massachusetts 02118 Not yet recruiting

ActivMed Practices & Research
Methuen Massachusetts 01844 Recruiting

Boston Center for Memory
Newton Massachusetts 02459 Recruiting

Donald S. Marks, MD. P.C.
Plymouth Massachusetts 02360 Recruiting

Hattiesburg Clinic
Hattiesburg Mississippi 39401 Not yet recruiting

Washington University
Saint Louis Missouri 63108 Recruiting

Millenium Psychiatric Associates, LLC
Saint Louis Missouri 63132 Not yet recruiting

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106 Not yet recruiting

Las Vegas Medical Research
Las Vegas Nevada 89113 Recruiting

Advanced Memory Research Institute of NJ, PC
Toms River New Jersey 08755 Recruiting

Neurology Specialists of Monmouth County, PA
West Long Branch New Jersey 07764 Recruiting

Albany Medical College
Albany New York 12208 Recruiting

Neurological Associates of Albany, PC
Albany New York 12208 Recruiting

New York University Medical Center PRIME
New York New York 10016 Recruiting

Cornell U - Weill Cornell Medicine
New York New York 10021 Not yet recruiting

Neurological Institute of New York
New York New York 10032 Recruiting

University of Rochester
Rochester New York 14620 Recruiting

ANI Neurology, PLLC d/b/a Alzheimer's Memory Center
Charlotte North Carolina 28270 Recruiting

Raleigh Neurology Associates, P.A. - Research Department
Raleigh North Carolina 27607 Recruiting

PMG Research of Winston Salem
Winston-Salem North Carolina 27103 Not yet recruiting

Insight Clinical Trials, LLC
Beachwood Ohio 44122 Withdrawn

OH Clinical Research Partners
Canton Ohio 44718 Not yet recruiting

Cleveland Clinic
Cleveland Ohio 44195 Recruiting

Columbs Neuroscience, LLC
Columbus Ohio 43020 Recruiting

Ohio State University
Columbus Ohio 43221 Recruiting

Summit Research Network (OR) Inc.
Portland Oregon 97210 Recruiting

Neural Net Research, LLC
Portland Oregon 97225 Recruiting

Oregon Health & Science University
Portland Oregon 97239 Not yet recruiting

Keystone Clinical Studies, LLC
Norristown Pennsylvania 19403 Recruiting

University of Pennsylvania
Philadelphia Pennsylvania 19104 Not yet recruiting

Rhode Island Mood & Memory Research Institute
East Providence Rhode Island 02914 Recruiting

Rhode Island Hospital
Providence Rhode Island 02903 Recruiting

Butler Hospital - Memory and Aging Program
Providence Rhode Island 02906 Recruiting

Roper St. Francis Healthcare
North Charleston South Carolina 29406 Not yet recruiting

Coastal Neurology, P.A.
Port Royal South Carolina 29935 Recruiting

Neurology Clinic, P.C.
Cordova Tennessee 38018 Recruiting

Alliance for Multispecialty Research LLC, New Orleans Center for Clinical Research / Volunteer Research Group, an AMR company
Knoxville Tennessee 37920 Recruiting

Senior Adult Specialty Research
Austin Texas 78757 Recruiting

Texas Neurology, PA
Dallas Texas 75214 Recruiting

Kerwin Research Center
Dallas Texas 75231 Recruiting

Baylor College of Medicine AD and Memory Disorders Center
Houston Texas 77030 Recruiting

Clinical Trial Network
Houston Texas 77074 Not yet recruiting

DBA The Memory Clinic
Bennington Vermont 05201 Recruiting

National Clinical Research Inc.-Richmond
Richmond Virginia 23294 Recruiting

Kingfisher Cooperative LLC
Spokane Washington 99202 Recruiting

Okanagan Clinical Trials
Kelowna British Columbia V1Y 1Z9 Recruiting

Health Research
West Vancouver British Columbia V7T 1C5 Recruiting

True North Clinical Research Halifax, Inc.
Halifax Nova Scotia B3S 1M7 Recruiting

True North Clinical Research Kentville, Inc.
Kentville Nova Scotia B4N 4K9 Recruiting

St. Joseph's HC- Parkwood Institute
London Ontario N6C 0A7 Recruiting

Recherches Neuro-Hippocampe, Inc., d/b/a Ottawa Memory Clinic
Ottawa Ontario K1Z 1G3 Recruiting

Kawartha Centre - Redefining Healthy Aging
Peterborough Ontario K9H 2P4 Recruiting

Toronto Memory Program (Neurology Research Inc.)
Toronto Ontario M3B 2S7 Recruiting

Recherches Neuro-Hippocampe Inc. d/b/a Clinique de la Mémoire de l'Outaouais
Gatineau Quebec J8T 8JI Recruiting

MoCA Clinic and Institute/NeuroSearch Developpements Inc.
Greenfield Park Quebec J4V 2J2 Recruiting

Q&T Research Sherbrooke Inc.
Sherbrooke Quebec J1J 2G2 Recruiting

CHU de Quebec - Hôpital de l' Enfant Jésus
Quebec Not yet recruiting

Eisai Inc.

  • Biogen

Name Phone Email
Eisai Medical Information 1-888-274-2378 esi_medinfo@eisai.com

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