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

Not Recruiting

Trial ID: NCT02008357


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)

Stanford Investigator(s)


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


drug: Solanezumab

drug: Placebo

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Tamara Beale