A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

Study Overview
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Brief Summary
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The study will evaluate the effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD. The study involves 3 parts. Part A in which participants will receive a single dose of LY3002813 or placebo (no drug). Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks. Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks. Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.

Official Title
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A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses of LY3002813 in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease or Mild to Moderate Alzheimer's Disease

Conditions
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Alzheimer Disease

Intervention / Treatment
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* Biological: LY3002813
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Present with mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild-to-moderate AD Men or nonfertile women, at least 50 years of age. Nonfertile is defined as hysterectomy and/or bilateral oophorectomy, or amenorrhea for at least 1 year Have up to 2 partners who will provide 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: Do not have up to 2 reliable partners who are in frequent contact with the participant, who will accompany the participant to the office and/or be available by telephone at designated times, and will monitor administration of prescribed medications Are being monitored for radiation due to occupational exposure to ionized radiation, or exposure to ionizing radiation within last 12 months from an investigational study History of intracranial hemorrhage, cerebrovascular aneurysm or arteriovenous malformation, or carotid artery occlusion, or stroke or epilepsy Have any contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, the presence of contraindicated metal (ferromagnetic) implants, cardiac pacemaker Have allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone Have gamma globulin therapy within the last year Previously dosed in any other study investigating active immunization against amyloid beta (Aβ) Previously dosed in any other study investigating passive immunization against Aβ within the last 6 months Have current serious or unstable illnesses

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LY3002813 Single dose 1<br>LY3002813 administered intravenously (IV) once | Biological: LY3002813<br>* Administered IV<br>|
| Experimental: LY3002813 Single dose 2<br>LY3002813 administered IV once | Biological: LY3002813<br>* Administered IV<br>|
| Experimental: LY3002813 Single dose 3<br>LY3002813 administered IV once | Biological: LY3002813<br>* Administered IV<br>|
| Experimental: LY3002813 Multiple dose 1 x 24 wks<br>LY3002813 administered IV for 24 wks | Biological: LY3002813<br>* Administered IV<br>|
| Experimental: LY3002813 Multiple dose 2 x 24 wks<br>LY3002813 administered IV for 24 weeks | Biological: LY3002813<br>* Administered IV<br>|
| Experimental: LY3002813 Multiple dose 3 x 72 wks<br>LY3002813 administered IV for 72 wks | Biological: LY3002813<br>* Administered IV<br>|
| Experimental: LY3002813 Multiple dose 4 x 72 weeks<br>LY3002813 administered IV for 72 wks | Biological: LY3002813<br>* Administered IV<br>|
| Placebo Comparator: Placebo given once<br>Placebo administered IV once | Drug: Placebo<br>* Administered IV<br>|
| Placebo Comparator: Placebo x 24 weeks<br>Placebo administered IV for 24 wks | Drug: Placebo<br>* Administered IV<br>|
| Placebo Comparator: Placebo x 72 weeks<br>Placebo administered IV for 72 wks | Drug: Placebo<br>* Administered IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr) |  | Predose up to Day 505 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics: Serum Concentrations of LY3002813 |  | Predose up to Day 589 | 
| Change from Baseline in Incidence of Anti-Drug Antibodies |  | Predose up to Day 589 |