A Study of LY2599666 in Healthy Participants and Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD)
Condition: Healthy; Alzheimer's Disease; Mild Cognitive Impairment
MeSH terms: Alzheimer Disease; Cognitive Dysfunction
Intervention: LY2599666; Solanezumab; Placebo SC; Placebo IV
Intervention description: Administered SC; Administered IV; Administered SC; Administered IV
Phase: Phase 1
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 50.0
Sex: All
Minimum age: 20 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      The main purpose of this study is to evaluate the safety and tolerability of the study drug
      known as LY2599666 in different groups of people - those who are healthy, those who have mild
      cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The
      study will measure how much LY2599666 gets into the bloodstream and how long it takes the
      body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has
      three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks.
      Participants may only enroll in one part.
    

Eligibility criteria:

        Inclusion Criteria:

        Healthy Participants Part A:

          -  Overtly healthy males or females as determined by medical history and physical
             examination

          -  Have a body mass index (BMI) between 18.0 and 32.0 kilograms per meter squared
             (kg/m²), inclusive

        Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]:

          -  Participants are at least 50 years old at screening

          -  Present with Mild Cognitive Impairment (MCI) due to Alzheimer's Disease (AD) or
             mild-to-moderate AD

          -  Have a caregiver/study informant who provides a separate written informed consent to
             participate

          -  Have adequate vision and hearing for neuropsychological testing in the opinion of the
             investigator

          -  Positive florbetapir scan

        Exclusion Criteria:

        All Participants

          -  Are currently enrolled in a clinical trial involving an investigational product or
             off-label use of a drug or device or are concurrently enrolled in any other type of
             medical research judged not to be scientifically or medically compatible with this
             study

          -  Have known allergies to LY2599666, solanezumab, or any related compounds or components
             of the formulations, or have a history of significant atopy

          -  Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the
             investigator, increases the risks associated with participating in the study

          -  Have an abnormal blood pressure as determined by the investigator

          -  Have significant allergies to humanized monoclonal antibodies, diphenhydramine,
             epinephrine, or methylprednisone

          -  Require treatment with other monoclonal antibodies

        Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part B and C]

          -  Have medical or surgical conditions in which lumbar puncture and or/catheter insertion
             is contraindicated

          -  Have any contraindication for magnetic resonance imaging (MRI) studies, including
             claustrophobia, the presence of metal (ferromagnetic) implants, or a cardiac pacemaker
             that is not compatible with MRI

        Participants With Mild Cognitive Impairment or Alzheimer's Disease (AD) [Part C]

          -  Have had lymphoma, leukemia, or any malignancy within the past 5 years except for
             basal cell or squamous epithelial carcinomas of the skin that have been resected with
             no evidence of metastatic disease for 3 years, cervical carcinoma in situ, or in situ
             prostate cancer with a normal prostate-specific antigen post treatment