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NCT02008357

PHASE3

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease \[AD\]).

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

Key Details

Gender

All

Age Range

65 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

1169

Start Date

2014-02-28

Completion Date

2023-06-08

Last Updated

2026-08-21

Healthy Volunteers

Conditions

Cognition Disorders

Interventions

DRUG

Placebo

Administered IV

DRUG

Solanezumab

Administered IV

Inclusion Criteria: * Has a Mini-Mental State Examination (MMSE) score at screening of 25 to 30 * Has a global Clinical Dementia Rating (CDR) scale score at screening of 0 * Has a Logical Memory II score at screening of 6 to 18 * Has a florbetapir positron emission tomography (PET) scan that shows evidence of brain amyloid pathology at screening * Has a study partner that is willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or electronic communication) Exclusion Criteria: * Is receiving a prescription acetylcholinesterase inhibitor (AChEI) and/or memantine at screening or baseline * Lacks good venous access, such that intravenous drug delivery or multiple blood draws would be precluded * Has current serious or unstable illness including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease or other conditions that, in the investigator's opinion, could interfere with the analyses of safety and efficacy in this study * Has had a 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 * Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of any in situ cancer that was appropriately treated and is being appropriately monitored, such as resected cutaneous squamous cell carcinoma in situ or in situ prostate cancer with normal prostate-specific antigen post-treatment * Has a 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) * Is clinically judged by the investigator to be at serious risk for suicide * Has a history within the past 2 years of major depression or bipolar disorder as defined by the most current version of the Diagnostic and Statistical Manual of Mental Disorders (DSM) * Has a history within the past 5 years of chronic alcohol or drug abuse/dependence as defined by the most current version of the DSM Open-Label Inclusion Criteria: * All participants who complete the placebo-controlled period will be allowed to continue into the open-label period

Locations (68)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Banner Health Research Institute

Phoenix, Arizona, United States

Barrow Neurological Institute

Phoenix, Arizona, United States

Banner Sun Health Research Institute

Sun City, Arizona, United States

Institute for Memory Impairment & Neurological Disorders

Irvine, California, United States

University of California - San Diego

La Jolla, California, United States

University of Southern California School of Medicine

Los Angeles, California, United States

University of California - Los Angeles

Los Angeles, California, United States

Univ of California Irvine College of Medicine

Orange, California, United States

Veterans Affairs Medical Center Palo Alto

Palo Alto, California, United States

Sutter Medical Group

Sacramento, California, United States

Univ of California San Francisco

San Francisco, California, United States

Syrentis Clinical Research

Santa Ana, California, United States

University of California, Davis - Health Systems

Walnut Creek, California, United States

Yale University School of Medicine

New Haven, Connecticut, United States

Georgetown University Hospital

Washington D.C., District of Columbia, United States

Howard University Hospital

Washington D.C., District of Columbia, United States

Brain Matters Research

Delray Beach, Florida, United States

Mayo Clinic-Jacksonville

Jacksonville, Florida, United States

Wien Center for Clinical Research

Miami Beach, Florida, United States

Compass Research - Orlando

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Compass Research -The Villages

The Villages, Florida, United States

Premiere Research Institute at Palm Beach Neurology

West Palm Beach, Florida, United States

Emory University

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Rush Alzheimer's Disease Center

Chicago, Illinois, United States

Great Lakes Clinical Trials

Chicago, Illinois, United States

Indiana University School of Medicine

Indianapolis, Indiana, United States

University of Iowa

Iowa City, Iowa, United States

University of Kansas Hospital

Fairway, Kansas, United States

University of Kentucky

Lexington, Kentucky, United States

Pennington Biomedical Research Center

Baton Rouge, Louisiana, United States

Johns Hopkins University School of Medicine

Baltimore, Maryland, United States

Brigham and Womens Hospital

Boston, Massachusetts, United States

Boston University Medical Center

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

Univ of Nebraska Med Center

Omaha, Nebraska, United States

Cleveland Clinic of Las Vegas

Las Vegas, Nevada, United States

Dent Neurological Institute

Amherst, New York, United States

New York University Medical Center

New York, New York, United States

Weill Cornell Medical College

New York, New York, United States

Mount Sinai School of Medicine

New York, New York, United States

Columbia University Medical Center

New York, New York, United States

University of Rochester

Rochester, New York, United States

Wake Forest University School of Medicine

Winston-Salem, North Carolina, United States

Case Western Reserve University

Beachwood, Ohio, United States

Tulsa Clinical Research LLC

Tulsa, Oklahoma, United States

Oregon Health and Science University

Portland, Oregon, United States

Drexel University College of Medicine at EPPI

Philadelphia, Pennsylvania, United States

University of Pennsylvania Hospital

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

Butler Hospital

Providence, Rhode Island, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Roper Hospital

Charleston, South Carolina, United States

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

University of Washington School of Medicine

Seattle, Washington, United States

University of Wisconsin-Madison Hospital and Health Clinic

Madison, Wisconsin, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Parkville, Victoria, Australia

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

London, Canada

Toronto, Canada

Sunnybrook Health Sciences Centre

Toronto, Canada

Vancouver, Canada

Bunkyō City, Japan

Clinical Research Directory

Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (68)