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Trial record 1 of 4 for:    alzheimers disease a4 texas
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Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss (A4)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02008357
Recruitment Status : Active, not recruiting
First Posted : December 11, 2013
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief 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]).

Condition or disease Intervention/treatment Phase
Cognition Disorders Drug: Solanezumab Drug: Placebo Phase 3

Detailed Description:
The A4 study is a clinical trial for older individuals who have evidence of amyloid plaque build-up in their brains who may be at risk for memory loss and cognitive decline due to Alzheimer's disease. The A4 study will test an anti-amyloid investigational drug in older individuals who do not yet show symptoms of Alzheimer's disease cognitive impairment or dementia with the aim of slowing memory and cognitive decline. The A4 study will also test whether anti-amyloid treatment can delay the progression of AD related brain injury on imaging and other biomarkers.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
Actual Study Start Date : February 2014
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Solanezumab
Solanezumab (400-1600 milligrams) intravenously (IV) every 4 weeks for 240 weeks.
Drug: Solanezumab
Administered IV
Other Name: LY2062430
Placebo Comparator: Placebo
Placebo IV every 4 weeks for 240 weeks.
Drug: Placebo
Administered IV


Outcome Measures

Primary Outcome Measures :
  1. Change from Baseline of the ADCS Preclinical Alzheimer Cognitive Composite (ADCS-PACC) to Week 240 [ Time Frame: Baseline, Week 240 ]

Secondary Outcome Measures :
  1. Change from Baseline in Cognitive Function Index (CFI) to Week 240 [ Time Frame: Baseline, Week 240 ]
  2. Change from Baseline in Alzheimer's Disease Cooperative Study—Activities Daily Living—Prevention Questionnaire (ADCS-ADL-Prevention Questionnaire) Score to Week 240 [ Time Frame: Baseline, Week 240 ]
  3. Change from Baseline in Mean Composite Standardized Uptake Value Ratio (SUVr) to Week 240 [ Time Frame: Baseline, Week 240 ]
  4. Change from Baseline in Cerebrospinal Fluid (CSF) Tau Biomarkers to Week 240 [ Time Frame: Baseline, 240 Weeks ]
  5. Change from Baseline of CSF Concentrations of Amyloid Beta (Abeta) to Week 240 [ Time Frame: Baseline, 240 Weeks ]
  6. Change from Baseline of Volumetric Magnetic Resonance Imaging (vMRI) to Week 240 [ Time Frame: Baseline, Week 240 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02008357


  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Health Research Institute
Phoenix, Arizona, United States, 85006
Barrow Neurological Institute
Phoenix, Arizona, United States, 85013
Banner Sun Health Research Institute
Sun City, Arizona, United States, 85351
United States, California
Institute for Memory Impairment & Neurological Disorders
Irvine, California, United States, 92697
University of California - San Diego
La Jolla, California, United States, 92037
University of Southern California School of Medicine
Los Angeles, California, United States, 90033
University of California - Los Angeles
Los Angeles, California, United States, 90095
Univ of California Irvine College of Medicine
Orange, California, United States, 92868
Veterans Affairs Medical Center Palo Alto
Palo Alto, California, United States, 94304
Sutter Medical Group
Sacramento, California, United States, 95816
Univ of California San Francisco
San Francisco, California, United States, 94158
Syrentis Clinical Research
Santa Ana, California, United States, 92705
University of California, Davis - Health Systems
Walnut Creek, California, United States, 94598
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Georgetown University Hospital
Washington, District of Columbia, United States, 20057
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
Brain Matters Research
Delray Beach, Florida, United States, 33445
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Wien Center for Clinical Research
Miami Beach, Florida, United States, 33140
Compass Research - Orlando
Orlando, Florida, United States, 32806
University of South Florida
Tampa, Florida, United States, 33613
Compass Research -The Villages
The Villages, Florida, United States, 32162
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States, 33407
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
Rush Alzheimer's Disease Center
Chicago, Illinois, United States, 60612
Great Lakes Clinical Trials
Chicago, Illinois, United States, 60640
United States, Indiana
Indiana University School of Medicine
Indianapolis, Indiana, United States, 46202
United States, Iowa
University of Iowa
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Hospital
Fairway, Kansas, United States, 66205
United States, Kentucky
University of Kentucky
Lexington, Kentucky, United States, 40504
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808-4124
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21093
United States, Massachusetts
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48105
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nebraska
Univ of Nebraska Med Center
Omaha, Nebraska, United States, 68198
United States, Nevada
Cleveland Clinic of Las Vegas
Las Vegas, Nevada, United States, 89106
United States, New York
Dent Neurological Institute
Amherst, New York, United States, 14226
New York University Medical Center
New York, New York, United States, 10016
Weill Cornell Medical College
New York, New York, United States, 10021
Mount Sinai School of Medicine
New York, New York, United States, 10029
Columbia University Medical Center
New York, New York, United States, 10032
University of Rochester
Rochester, New York, United States, 14620
United States, North Carolina
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Case Western Reserve University
Beachwood, Ohio, United States, 44122
United States, Oklahoma
Tulsa Clinical Research LLC
Tulsa, Oklahoma, United States, 74104
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Drexel University College of Medicine at EPPI
Philadelphia, Pennsylvania, United States, 19102
University of Pennsylvania Hospital
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Butler Hospital
Providence, Rhode Island, United States, 02906
Rhode Island Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Roper Hospital
Charleston, South Carolina, United States, 29401
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
Baylor College of Medicine
Houston, Texas, United States, 77030
Houston Methodist
Houston, Texas, United States, 77030
United States, Washington
University of Washington School of Medicine
Seattle, Washington, United States, 98108
United States, Wisconsin
University of Wisconsin-Madison Hospital and Health Clinic
Madison, Wisconsin, United States, 53705
Australia, Victoria
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, 3010
Canada
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, N6C 0A7
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.
Toronto, Canada, M3B2S7
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.
Toronto, Canada, M4N 3M5
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.
Vancouver, Canada, V6T 2B5
Japan
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.
Bunkyo-ku, Japan, 113-8655
Sponsors and Collaborators
Eli Lilly and Company
Alzheimer's Therapeutic Research Institute
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
More Information

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02008357     History of Changes
Other Study ID Numbers: 15275
H8A-MC-LZAZ ( Other Identifier: Eli Lilly and Company )
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
Cognition
Prevention

Additional relevant MeSH terms:
Cognition Disorders
Neurocognitive Disorders
Mental Disorders