A Study of LY3002813 in Participants With Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:18 - Any
Updated:12/27/2017
Start Date:May 3, 2013
End Date:August 24, 2016

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A Single-Dose and Multiple-Dose, Dose-Escalation Study to Evaluate the Safety, Tolerability, and Pharmacokinetics 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 safety of LY3002813 by looking at adverse events. The study will
also look at the effect the body has on LY3002813. Study participants will be healthy or will
have mild cognitive impairment (MCI) due to Alzheimer's disease (AD) or mild to moderate AD.

There will be seven groups of study participants. Five groups will receive a single dose of
LY3002813 or placebo (no drug), followed by up to 4 multiple doses of LY3002813 or placebo
given as an injection into a vein. Approximately 12 weeks will pass between the single dose
and the first multiple dose. One group of participants will receive a single dose of
LY3002813 given as an injection under the skin. One group of participants will receive a
single dose of LY3002813 given as an injection into a vein.


Inclusion Criteria:

- Healthy Participants:

- Overtly healthy males, as determined by medical history and physical examination,
willing to use a reliable method of birth control and will not donate sperm
during the study

- Between 18 to 40 years old.

- Body Mass Index (BMI) of between 18.0 and 30.0 kilogram per meter square
(kg/m^2), inclusive

- Participants with Mild Cognitive Impairment Due to Alzheimer's Disease (AD) or AD:

- Present with mild cognitive impairment (MCI) due to 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 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:

-Healthy Participants: Have a history or presence of cardiovascular, respiratory, hepatic,
renal, gastrointestinal, endocrine, hematological, immunological, or neurological disorders
capable of significantly altering the absorption,metabolism, or elimination of drugs; of
constituting a risk when taking the study medication; or of interfering with the
interpretation of data

- Participants with Mild Cognitive Impairment Due to AD or AD:

- Do not have a reliable caregiver/study informant who is 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 within the past 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 post resection

- All Participants:

- 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
We found this trial at
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Long Beach, California 90806
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100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
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811 Juniper St NE
Atlanta, Georgia 30308
(404) 881-5800
Atlanta Center for Medical Research Welcome to the Atlanta Center for Medical Research, a leader...
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Salt Lake City, Utah 84106
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