Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 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]).
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.
Phase
Phase 3 - a treatment has shown activity against a particular disease, where it is either added to existing treatment or compared to the standard treatment.Inclusion and Exclusion 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)
- 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
Sites
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California
- University of Southern California School of Medicine, Los Angeles, California, 90033
- 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
- Institute for Memory Impairment & Neurological Disorders, Irvine, California, 92697
- University of California, Irvine, Irvine, California, 92697
- University of California, Irvine, Irvine, California, 92697
- University of California - San Diego, La Jolla, California, 92037
- Stanford University, Palo Alto, California, 94304
- University of California, Davis - Health Systems, Martinez, California, 94553
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Nevada
- Cleveland Clinic of Las Vegas, Las Vegas, Nevada, 89106
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Arizona
- Banner Sun Health Research Institute, Sun City, Arizona, 85351
- Banner Sun Health Research Institute, Sun City, Arizona, 85351
- Banner Health Research Institute, Phoenix, Arizona, 85006
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Utah
- University of Utah School of Medicine, Salt Lake City, Utah, 84132
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Oregon
- Oregon Health and Science University, Portland, Oregon, 97239
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Washington
- University of Washington School of Medicine, Seattle, Washington, 98108
- University of Washington School of Medicine, Seattle, Washington, 98108
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Texas
- University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, 75390
- Baylor College of Medicine, Houston, Texas, 77030
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Oklahoma
- Tulsa Clinical Research LLC, Tulsa, Oklahoma, 74104
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Nebraska
- Univ of Nebraska Med Center, Omaha, Nebraska, 68198
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Kansas
- University of Kansas Hospital, Fairway, Kansas, 66205
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Minnesota
- Mayo Clinic, Rochester, Minnesota, 55905
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Iowa
- University of Iowa, Iowa City, Iowa, 52242
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Missouri
- Washington University School of Medicine, St. Louis, Missouri, 63110
- Washington University School of Medicine, St. Louis, Missouri, 63110
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Wisconsin
- University of Wisconsin-Madison Hospital and Health Clinic, Madison, Wisconsin, 53705
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Illinois
- Rush Alzheimer's Disease Center, Chicago, Illinois, 60612
- Northwestern University, Chicago, Illinois, 60611
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Alabama
- University of Alabama at Birmingham, Birmingham, Alabama, 35294
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Indiana
- Indiana University School of Medicine, Indianapolis, Indiana, 46202
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Kentucky
- University of Kentucky, Lexington, Kentucky, 40504
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Georgia
- Emory University, Atlanta, Georgia, 30322
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