Clinical Trial of Solanezumab for Older Individuals Who May be at Risk for Memory Loss
Condition: Cognition Disorders
MeSH terms: Cognition Disorders
Intervention: Placebo; Solanezumab
Intervention description: Administered IV; Administered IV
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 1169.0
Sex: All
Minimum age: 65 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Cognition; Prevention

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]).
    

Eligibility 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

        Open-Label Inclusion Criteria:

          -  All participants who complete the placebo-controlled period will be allowed to
             continue into the open-label period