Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
a study on Cognition Disorders Alzheimer's Disease
Summary
- Eligibility
- for people ages 65-85 (full criteria)
- Location
- at Orange, California and other locations
- Dates
- study startedestimated completion
Description
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)
Details
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.
Keywords
Cognition Disorders, Cognition, Prevention, Solanezumab
Eligibility
You can join if…
Open to people ages 65-85
- 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)
You CAN'T join if...
- 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
- Univ of California Irvine College of Medicine
Orange California 92868 United States - Institute for Memory Impairment & Neurological Disorders
Irvine California 92697 United States - Syrentis Clinical Research
Santa Ana California 92705 United States - University of California - Los Angeles
Los Angeles California 90095 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Eli Lilly and Company
- ID
- NCT02008357
- Phase
- Phase 3 research study
- Study Type
- Interventional
- Participants
- Expecting 1150 study participants
- Last Updated