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Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease (A4 Study)


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]).


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


  • 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
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