Status:
COMPLETED
A Study of LY3002813 in Participants With Alzheimer's Disease
Lead Sponsor:
Eli Lilly and Company
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
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 cog...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 24 2016
Estimated Enrollment :
63 Patients enrolled
Trial Details
Trial ID
NCT01837641
Start Date
May 3 2013
End Date
August 24 2016
Last Update
October 4 2024
Active Locations (6)
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1
Collaborative Neuroscience Network - CNS
Long Beach, California, United States, 90806
2
Compass Research
Orlando, Florida, United States, 32806
3
Atlanta Center of Medical Research
Atlanta, Georgia, United States, 30308
4
PRAHealthSciences
Salt Lake City, Utah, United States, 84106