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

Start: February 2014
End: December 2020
Enrollment: 1150

What Is This Study About?

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.

Do I Qualify To Participate in This Study?

Minimum Age: 65 Years

Maximum Age: 85 Years

Must have:

  • 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

Must NOT have:

  • 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
 

Who Is the General Study Contact?

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.

Study Contact
Alzheimer's Therapeutic Research Institute
1-844-247-8839
A4-participate@usc.edu

Need Help?

Contact NIA’s Alzheimer’s and related Dementias Education and Referral (ADEAR) Center at 800-438-4380 or email ADEAR.

Where Is This Study Located?

Alabama
University of Alabama at Birmingham
Birmingham, AL 35294
Arizona
Banner Health Research Institute
Phoenix, AZ 85006
Barrow Neurological Institute
Phoenix, AZ 85013
Banner Sun Health Research Institute
Sun City, AZ 85351
California
Institute for Memory Impairment & Neurological Disorders
Irvine, CA 92697
University of California - San Diego
La Jolla, CA 92037
University of Southern California School of Medicine
Los Angeles, CA 90033
University of California - Los Angeles
Los Angeles, CA 90095
Univ of California Irvine College of Medicine
Orange, CA 92868
Veterans Affairs Medical Center Palo Alto
Palo Alto, CA 94304
Sutter Medical Group
Sacramento, CA 95816
Univ of California San Francisco
San Francisco, CA 94158
Syrentis Clinical Research
Santa Ana, CA 92705
University of California, Davis - Health Systems
Walnut Creek, CA 94598
Connecticut
Yale University School of Medicine
New Haven, CT 06510
District of Columbia
Georgetown University Hospital
Washington, DC 20057
Howard University Hospital
Washington, DC 20060
Florida
Brain Matters Research
Delray Beach, FL 33445
Mayo Clinic-Jacksonville
Jacksonville, FL 32224
Wien Center for Clinical Research
Miami Beach, FL 33140
Compass Research - Orlando
Orlando, FL 32806
University of South Florida
Tampa, FL 33613
Compass Research -The Villages
The Villages, FL 32162
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, FL 33407
Georgia
Emory University
Atlanta, GA 30322
Illinois
Northwestern University
Chicago, IL 60611
Rush Alzheimer's Disease Center
Chicago, IL 60612
Great Lakes Clinical Trials
Chicago, IL 60640
Indiana
Indiana University School of Medicine
Indianapolis, IN 46202
Iowa
University of Iowa
Iowa City, IA 52242
Kansas
University of Kansas Hospital
Fairway, KS 66205
Kentucky
University of Kentucky
Lexington, KY 40504
Louisiana
Pennington Biomedical Research Center
Baton Rouge, LA 70808-4124
Maryland
Johns Hopkins University School of Medicine
Baltimore, MD 21093
Massachusetts
Brigham and Womens Hospital
Boston, MA 02115
Boston University Medical Center
Boston, MA 02118
Michigan
University of Michigan
Ann Arbor, MI 48105
Minnesota
Mayo Clinic
Rochester, MN 55905
Missouri
Washington University School of Medicine
Saint Louis, MO 63110
Nebraska
Univ of Nebraska Med Center
Omaha, NE 68198
Nevada
Cleveland Clinic of Las Vegas
Las Vegas, NV 89106
New York
Dent Neurological Institute
Amherst, NY 14226
New York University Medical Center
New York, NY 10016
Weill Cornell Medical College
New York, NY 10021
Mount Sinai School of Medicine
New York, NY 10029
Columbia University Medical Center
New York, NY 10032
University of Rochester
Rochester, NY 14620
North Carolina
Wake Forest University School of Medicine
Winston-Salem, NC 27157
Ohio
Case Western Reserve University
Beachwood, OH 44122
Oklahoma
Tulsa Clinical Research LLC
Tulsa, OK 74104
Oregon
Oregon Health and Science University
Portland, OR 97239
Pennsylvania
Drexel University College of Medicine at EPPI
Philadelphia, PA 19102
University of Pennsylvania Hospital
Philadelphia, PA 19104
University of Pittsburgh Medical Center
Pittsburgh, PA 15213
Rhode Island
Butler Hospital
Providence, RI 02906
Rhode Island Hospital
Providence, RI 02906
South Carolina
Roper Hospital
Charleston, SC 29401
Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, TX 75235
Baylor College of Medicine
Houston, TX 77030
Houston Methodist
Houston, TX 77030
Washington
University of Washington School of Medicine
Seattle, WA 98108
Wisconsin
University of Wisconsin-Madison Hospital and Health Clinic
Madison, WI 53705
British Columbia
Site
Vancouver, BC V6T 2B5
Ontario
Site
London, ON N6C 0A7
Site
Toronto, ON M3B2S7
Site
Toronto, ON M4N 3M5

Who Sponsors This Study?

Lead: Eli Lilly and Company

Collaborator Sponsor

  • Alzheimer's Therapeutic Research Institute (ATRI)

Source: ClinicalTrials.gov ID: NCT02008357