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 | |
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University of Alabama at Birmingham
Birmingham, AL 35294
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| Arizona | |
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Banner Health Research Institute
Phoenix, AZ 85006
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Barrow Neurological Institute
Phoenix, AZ 85013
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Banner Sun Health Research Institute
Sun City, AZ 85351
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| California | |
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Institute for Memory Impairment & Neurological Disorders
Irvine, CA 92697
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University of California - San Diego
La Jolla, CA 92037
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University of Southern California School of Medicine
Los Angeles, CA 90033
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University of California - Los Angeles
Los Angeles, CA 90095
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Univ of California Irvine College of Medicine
Orange, CA 92868
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Veterans Affairs Medical Center Palo Alto
Palo Alto, CA 94304
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Sutter Medical Group
Sacramento, CA 95816
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Univ of California San Francisco
San Francisco, CA 94158
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Syrentis Clinical Research
Santa Ana, CA 92705
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University of California, Davis - Health Systems
Walnut Creek, CA 94598
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| Connecticut | |
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Yale University School of Medicine
New Haven, CT 06510
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| District of Columbia | |
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Georgetown University Hospital
Washington, DC 20057
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Howard University Hospital
Washington, DC 20060
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| Florida | |
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Brain Matters Research
Delray Beach, FL 33445
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Mayo Clinic-Jacksonville
Jacksonville, FL 32224
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Wien Center for Clinical Research
Miami Beach, FL 33140
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Compass Research - Orlando
Orlando, FL 32806
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University of South Florida
Tampa, FL 33613
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Compass Research -The Villages
The Villages, FL 32162
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Premiere Research Institute at Palm Beach Neurology
West Palm Beach, FL 33407
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| Georgia | |
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Emory University
Atlanta, GA 30322
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| Illinois | |
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Northwestern University
Chicago, IL 60611
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Rush Alzheimer's Disease Center
Chicago, IL 60612
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Great Lakes Clinical Trials
Chicago, IL 60640
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| Indiana | |
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Indiana University School of Medicine
Indianapolis, IN 46202
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| Iowa | |
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University of Iowa
Iowa City, IA 52242
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| Kansas | |
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University of Kansas Hospital
Fairway, KS 66205
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| Kentucky | |
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University of Kentucky
Lexington, KY 40504
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| Louisiana | |
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Pennington Biomedical Research Center
Baton Rouge, LA 70808-4124
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| Maryland | |
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Johns Hopkins University School of Medicine
Baltimore, MD 21093
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| Massachusetts | |
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Brigham and Womens Hospital
Boston, MA 02115
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Boston University Medical Center
Boston, MA 02118
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| Michigan | |
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University of Michigan
Ann Arbor, MI 48105
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| Minnesota | |
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Mayo Clinic
Rochester, MN 55905
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| Missouri | |
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Washington University School of Medicine
Saint Louis, MO 63110
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| Nebraska | |
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Univ of Nebraska Med Center
Omaha, NE 68198
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| Nevada | |
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Cleveland Clinic of Las Vegas
Las Vegas, NV 89106
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| New York | |
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Dent Neurological Institute
Amherst, NY 14226
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New York University Medical Center
New York, NY 10016
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Weill Cornell Medical College
New York, NY 10021
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Mount Sinai School of Medicine
New York, NY 10029
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Columbia University Medical Center
New York, NY 10032
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University of Rochester
Rochester, NY 14620
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| North Carolina | |
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Wake Forest University School of Medicine
Winston-Salem, NC 27157
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| Ohio | |
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Case Western Reserve University
Beachwood, OH 44122
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| Oklahoma | |
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Tulsa Clinical Research LLC
Tulsa, OK 74104
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| Oregon | |
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Oregon Health and Science University
Portland, OR 97239
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| Pennsylvania | |
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Drexel University College of Medicine at EPPI
Philadelphia, PA 19102
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University of Pennsylvania Hospital
Philadelphia, PA 19104
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University of Pittsburgh Medical Center
Pittsburgh, PA 15213
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| Rhode Island | |
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Butler Hospital
Providence, RI 02906
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Rhode Island Hospital
Providence, RI 02906
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| South Carolina | |
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Roper Hospital
Charleston, SC 29401
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| Texas | |
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University of Texas Southwestern Medical Center at Dallas
Dallas, TX 75235
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Baylor College of Medicine
Houston, TX 77030
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Houston Methodist
Houston, TX 77030
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| Washington | |
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University of Washington School of Medicine
Seattle, WA 98108
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| Wisconsin | |
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University of Wisconsin-Madison Hospital and Health Clinic
Madison, WI 53705
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| British Columbia | |
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Site
Vancouver, BC V6T 2B5
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| Ontario | |
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Site
London, ON N6C 0A7
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Site
Toronto, ON M3B2S7
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Site
Toronto, ON M4N 3M5
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Who Sponsors This Study?
Lead: Eli Lilly and Company
Collaborator Sponsor
- Alzheimer's Therapeutic Research Institute (ATRI)
Source: ClinicalTrials.gov ID: NCT02008357