LY3002813 for Mild Cognitive Impairment and Alzheimer's Disease
LY3002813 for Mild Cognitive Impairment and Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
This Phase I study will evaluate the safety and efficacy of the experimental drug LY3002813 in people with mild cognitive impairment (MCI) due to Alzheimer's disease or or mild to moderate Alzheimer's.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | N/A | Both | No |
Inclusion Criteria:
- Mild cognitive impairment (MCI) due to Alzheimer's disease or mild to moderate Alzheimer's
- Women must be nonfertile, with hysterectomy and/or bilateral oophorectomy or no menstruation for at least 1 year
- Availability of caregiver/study informant who will accompany participant to all visits, be available by telephone at designated times, and monitor administration of study drug
- Adequate vision and hearing for neuropsychological testing
- Florbetapir brain scan showing evidence of Alzheimer's brain changes
Exclusion Criteria:
- History of intracranial hemorrhage, cerebrovascular aneurysm, arteriovenous malformation, carotid artery occlusion, stroke, or epilepsy
- Contraindications for magnetic resonance imaging (MRI) studies, including claustrophobia, metal (ferromagnetic) implants, or cardiac pacemaker
- Monitoring for radiation due to occupational exposure to ionized radiation or exposure to ionizing radiation within the last 12 months from an investigational study
- Allergies to humanized monoclonal antibodies, including proteins and diphenhydramine, epinephrine, and methylprednisolone
- Gamma globulin therapy within the last year
- Participation within the last 6 months in any study investigating active or passive immunization against amyloid beta
- History within the last 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
Detailed Description:
Participants with MCI or mild to moderate Alzheimer's disease will help test the safety and efficacy of different doses of LY3002813. There will be six groups of study participants. Five groups will receive a single dose of LY3002813 or a placebo (no drug), followed by up to four 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.
Central Contact Information:
For more information about this trial or the study sites, call Eli Lilly toll-free at 1-877-285-4559, Monday through Friday, between 9 a.m. and 5 p.m. Eastern time.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.8065036, -118.1912538 | Long Beach | California | 90806 | Recruiting | Name: Phone: | |
Geolocation is 28.5085825, -81.3564411 | Orlando | Florida | 32806 | Recruiting | Name: Phone: | |
Geolocation is 33.7717008, -84.3726049 | Atlanta | Georgia | 30308 | Recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Eli Lilly and Company |
Collaborator Sponsor:
Facility Investigators:
| Affiliation |
|---|
Eli Lilly and Company |
Study Contact:
| Name | Phone |
|---|---|
Eli Lilly | 1-877-285-4559 |
Locations
ClinicalTrials.gov ID
NCT01837641 (follow link to view full record on ct.gov in new window)
Official Title:
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
Study Start Date:
May 2013
Study End Date:
March 2015
Disease Stage:
Early
Middle
Enrollment:
100
