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

Status:	Active, not recruiting
Conditions:	Alzheimer Disease
Therapuetic Areas:	Neurology
Healthy:	No
Age Range:	50 - Any
Updated:	12/6/2018
Start Date:	December 22, 2015
End Date:	May 6, 2020

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

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.

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

We found this trial at

sites

St. Louis Clinical Trials, LC

10330 Old Olive Street Road
Saint Louis, Missouri 63141

Principal Investigator: Daniel Gruener

Phone: 314-771-6387

from

Saint Louis, MO