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Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4)

Active, not recruiting

This study will test whether an investigational drug, solanezumab, can slow the progression of memory problems associated with amyloid, a protein that forms plaques in the brains of people with Alzheimer disease. Participants who have normal thinking and memory function but may be at risk for developing Alzheimer's dementia are invited to participate. All volunteers will undergo a positron emission tomography (PET) scan to be determine their brain amyloid levels.

Minimum Age Maximum Age Gender Healthy Volunteers
65 Years 85 Years Both Yes
February 2014
December 2020
1150

  • Mini-Mental State Examination (MMSE) score of 25-30 inclusive
  • Global Clinical Dementia Rating (CDR) scale score of 0
  • Logical Memory II score of 6-18
  • PET scan that shows evidence of amyloid in the brain at screening
  • Study partner who has at least weekly contact with the participant (contact can be in person, via telephone, or by e-mail or other electronic means) and can provide information about him or her

  • Taking a prescription Alzheimer's medication (acetylcholinesterase inhibitor and/or memantine)
  • Lack of good venous access that precludes intravenous drug delivery or multiple blood draws
  • Current serious or unstable illness, including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that could interfere with the study
  • History within the last 5 years of a serious infectious disease affecting the brain (including neurosyphilis, meningitis, or encephalitis) or head trauma resulting in protracted loss of consciousness
  • History within the last 5 years of a primary or recurrent malignant disease, with the exception of resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment
  • Known history of human immunodeficiency virus (HIV), clinically significant multiple or severe drug allergies, or severe post-treatment hypersensitivity reactions, including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, or exfoliative dermatitis
  • At serious risk for suicide; history within the past 2 years of major depression or bipolar disorder
  • History within the past 5 years of chronic alcohol or drug abuse/dependence
  • Residence in a skilled nursing facility or nursing home

The A4 study is a Phase III clinical trial for cognitively normal older adults whose brain scans show evidence of amyloid buildup, which places them at risk for memory loss and cognitive decline associated with Alzheimer's disease. The study will test the safety and efficacy of solanezumab, a monoclonal antibody, to see if it slows memory and cognitive decline and affects the buildup of amyloid plaques, as shown by brain imaging and other biomarkers. Participants will take either the study drug or a placebo as a monthly intravenous infusion for 3 years. Participants who do not qualify for A4 may be able to participate in a related substudy.

For more information about the A4 trial or study sites, please visit www.a4study.org. You may also call 1-844-A4-STUDY (1-844-247-8839) or e-mail A4-participate@usc.edu.

Name City State Zip Status Primary Contact
University of Alabama at Birmingham
Birmingham Alabama 35294

Banner Health Research Institute
Phoenix Arizona 85006

Barrow Neurological Institute
Phoenix Arizona 85013

Banner Sun Health Research Institute
Sun City Arizona 85351

Institute for Memory Impairment & Neurological Disorders
Irvine California 92697

University of California - San Diego
La Jolla California 92037

University of Southern California School of Medicine
Los Angeles California 90033

University of California - Los Angeles
Los Angeles California 90095

Univ of California Irvine College of Medicine
Orange California 92868

Veterans Affairs Medical Center Palo Alto
Palo Alto California 94304

Sutter Medical Group
Sacramento California 95816

Univ of California San Francisco
San Francisco California 94158

Syrentis Clinical Research
Santa Ana California 92705

University of California, Davis - Health Systems
Walnut Creek California 94598

Yale University School of Medicine
New Haven Connecticut 06510

Georgetown University Hospital
Washington District of Columbia 20057

Howard University Hospital
Washington District of Columbia 20060

Brain Matters Research
Delray Beach Florida 33445

Mayo Clinic-Jacksonville
Jacksonville Florida 32224

Wien Center for Clinical Research
Miami Beach Florida 33140

Compass Research - Orlando
Orlando Florida 32806

University of South Florida
Tampa Florida 33613

Compass Research -The Villages
The Villages Florida 32162

Premiere Research Institute at Palm Beach Neurology
West Palm Beach Florida 33407

Emory University
Atlanta Georgia 30322

Northwestern University
Chicago Illinois 60611

Rush Alzheimer's Disease Center
Chicago Illinois 60612

Great Lakes Clinical Trials
Chicago Illinois 60640

Indiana University School of Medicine
Indianapolis Indiana 46202

University of Iowa
Iowa City Iowa 52242

University of Kansas Hospital
Fairway Kansas 66205

University of Kentucky
Lexington Kentucky 40504

Pennington Biomedical Research Center
Baton Rouge Louisiana 70808-4124

Johns Hopkins University School of Medicine
Baltimore Maryland 21093

Brigham and Womens Hospital
Boston Massachusetts 02115

Boston University Medical Center
Boston Massachusetts 02118

University of Michigan
Ann Arbor Michigan 48105

Mayo Clinic
Rochester Minnesota 55905

Washington University School of Medicine
Saint Louis Missouri 63110

Univ of Nebraska Med Center
Omaha Nebraska 68198

Cleveland Clinic of Las Vegas
Las Vegas Nevada 89106

Dent Neurological Institute
Amherst New York 14226

New York University Medical Center
New York New York 10016

Weill Cornell Medical College
New York New York 10021

Mount Sinai School of Medicine
New York New York 10029

Columbia University Medical Center
New York New York 10032

University of Rochester
Rochester New York 14620

Wake Forest University School of Medicine
Winston-Salem North Carolina 27157

Case Western Reserve University
Beachwood Ohio 44122

Tulsa Clinical Research LLC
Tulsa Oklahoma 74104

Oregon Health and Science University
Portland Oregon 97239

Drexel University College of Medicine at EPPI
Philadelphia Pennsylvania 19102

University of Pennsylvania Hospital
Philadelphia Pennsylvania 19104

University of Pittsburgh Medical Center
Pittsburgh Pennsylvania 15213

Butler Hospital
Providence Rhode Island 02906

Rhode Island Hospital
Providence Rhode Island 02906

Roper Hospital
Charleston South Carolina 29401

University of Texas Southwestern Medical Center at Dallas
Dallas Texas 75235

Baylor College of Medicine
Houston Texas 77030

Houston Methodist
Houston Texas 77030

University of Washington School of Medicine
Seattle Washington 98108

University of Wisconsin-Madison Hospital and Health Clinic
Madison Wisconsin 53705

Site
Vancouver British Columbia V6T 2B5

Site
London Ontario N6C 0A7

Site
Toronto Ontario M3B2S7

Site
Toronto Ontario M4N 3M5

Eli Lilly and Company

  • Alzheimer's Therapeutic Research Institute (ATRI)

Name Role Affiliation
Eli Lilly Study Director

Name Phone Email
Alzheimer's Therapeutic Research Institute 1-844-247-8839 A4-participate@usc.edu

NCT02008357

Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)