A Study of LY2886721 in Healthy Participants and Participants Diagnosed With Alzheimer's Disease
Condition: Alzheimer Disease; Healthy Volunteers
MeSH terms: Alzheimer Disease
Intervention: LY2886721; Placebo
Phase: Phase 1
Study type: Interventional
Primary purpose: Basic Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 36.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is being done for the following reasons:

      To determine the safety of LY2886721 and any side effects that may be associated with it and
      to see how much of the study drug is in the blood and the cerebrospinal fluid (CSF) when one
      dose is given to healthy participants and participants diagnosed with Alzheimer's disease. It
      will also look at how safe and tolerable the study drug is when given to healthy participants
      in higher doses.

      This research study is being conducted in three groups, referred to as Groups (Cohorts) A, B,
      or C.

      Group A will enroll participants with Alzheimer's disease while Groups B and C will enroll
      healthy participants.

      For Group A or B, participation in this research study could last up to 34 days. For Group C,
      participation could last up to 60 days.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Healthy participants have a body mass index (BMI) of 19 to 32 kilograms per square
             meter (kg/m^2), inclusive, at screening. There are no restrictions on BMI in
             participants diagnosed with Alzheimer's disease.

          -  Healthy participants should not be taking any concomitant medications. For
             participants with Alzheimer's disease, concomitant medications will be determined by
             the investigator in consultation with the Lilly clinical pharmacologist on an
             individual basis.

        Cohort A:

          -  Participants are defined as otherwise healthy males or females as determined by
             medical history and physical examination, and a diagnosis of Alzheimer's disease and
             must be at least 45 years of age.

          -  Meets National Institute of Neurological and Communicative Disorders and
             Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria
             for probable Alzheimer's disease, as determined by a clinician approved by the sponsor
             or designee.

          -  Mini Mental State Examination (MMSE) score of 16 through 28 at screening.

          -  Modified Hachinski Ischemia Scale (MHIS) score of <4.

          -  Capable of understanding and signing their own informed consent, in the opinion of the
             investigator, or if the participant has a Legally Authorized Representative (LAR),
             then the LAR must be capable of understanding and signing the assent form, and the
             participant may or may not sign the informed consent, as to be determined by the
             investigator.

          -  If receiving concurrent treatment with an acetylcholinesterase inhibitor (AChEI)
             and/or memantine, the participant has been on a stable dose for at least 4 weeks
             before Day 1. Dosing must remain stable throughout the study. Note: If a participant
             has recently stopped ACHEIs and/or memantine, he or she must have discontinued
             treatment for at least 4 weeks before Day 1.

        Exclusion Criteria:

          -  Have an abnormality in the 12-lead electrocardiogram (ECG).

          -  Have abnormal blood pressure.

          -  Have abnormal thyroid function as reflected by thyroid stimulating hormone (TSH)
             values outside of the normal range.

          -  Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV
             antibodies.

          -  Show evidence of hepatitis C and/or positive hepatitis C antibody.

          -  Have had multiple episodes of head trauma, or have a history within the last 5 years
             of a serious infectious disease affecting the brain.

          -  Have chronic hepatic disease.

          -  Have evidence or history of significant active bleeding or a coagulation disorder.

          -  Cohort A: have any neurological disorders other than Alzheimer's disease.

          -  For healthy participants (Cohorts B and C) only: Use or intend to use over the-
             counter or prescription medication, including herbal medications within 14 days prior
             to dosing or during the study.