Progress of Mild Alzheimer's Disease in Participants on Solanezumab Versus Placebo
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Intervention: Solanezumab; Placebo
Intervention description: Administered Intravenously (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: 2129.0
Sex: All
Minimum age: 55 Years
Maximum age: 90 Years
Healthy volunteers: No

Summary:

      To test the idea that solanezumab will slow the cognitive decline of Alzheimer's Disease (AD)
      as compared with placebo in participants with mild AD.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Meets National Institute of Neurological and Communicative Disorders and
             Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
             for probable AD

          -  Has a Modified Hachinski Ischemia Scale score of less than or equal to 4

          -  Has a Mini-Mental State Examination (MMSE) score of 20 through 26 at Screening visit

          -  Has a Geriatric Depression Scale score of less than or equal to 6 (on the
             staff-administered short form)

          -  Has had a magnetic resonance imaging (MRI) or computerized tomography (CT) scan
             performed within the past 2 years that has confirmed no findings inconsistent with a
             diagnosis of AD

          -  Has a florbetapir positron emission tomography (PET) scan or cerebrospinal fluid (CSF)
             result consistent with the presence of amyloid pathology at screening

        Exclusion Criteria:

          -  Does not have a reliable caregiver who is in frequent contact with the participant
             (defined as at least 10 hours per week), will accompany the participant to the office
             and/or be available by telephone at designated times, and will monitor administration
             of prescribed medications

          -  Meets National Institute of Neurological Disorders and Stroke/Association
             Internationale pour la Recherche et l'Enseignement en Neurosciences (NINDS/AIREN)
             criteria for vascular dementia

          -  Has current serious or unstable illnesses including cardiovascular, hepatic, renal,
             gastroenterologic, respiratory, endocrinologic, neurologic (other than AD),
             psychiatric, immunologic, or hematologic disease and other conditions that, in the
             investigator's opinion, could interfere with the analyses of safety and efficacy in
             this study; or has a life expectancy of <2 years

          -  Has had a history within the last 5 years of a serious infectious disease affecting
             the brain or head trauma resulting in protracted loss of consciousness

          -  Has a history within the last 5 years of a primary or recurrent malignant disease with
             the exception of resected cutaneous squamous cell carcinoma in situ, basal cell
             carcinoma, cervical carcinoma in situ, or in situ prostate cancer with a normal
             prostate-specific antigen posttreatment

          -  Has a known history of human immunodeficiency virus (HIV), clinically significant
             multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions

          -  Has received acetylcholinesterase inhibitor (AChEIs), memantine and/or other AD
             therapy for less than 4 months or has less than 2 months of stable therapy on these
             treatments

          -  Has received medications that affect the central nervous system (CNS), except
             treatments for AD, for less than 4 weeks

          -  Has a history of chronic alcohol or drug abuse/dependence within the past 5 years

          -  Has a Visit 1 MRI with results showing >4 Amyloid-related Imaging Abnormality (ARIA),
             -hemorrhage /hemosiderin deposition (ARIA-H) or presence of ARIA-E (edema/effusions)