A Study of LY3002813 in Participants With Alzheimer's Disease

NCT ID: NCT01837641

Last Updated: 2024-10-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-03
• Study Completion Date: 2016-08-24

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 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.

Conditions

Alzheimer Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg

0.1 milligram per kilogram (mg/kg) single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks intravenously (IV)

Group Type: EXPERIMENTAL

LY3002813-IV

Intervention Type: BIOLOGICAL

Administered IV

LY3002813-Single then multiple 0.3 mg/kg

0.3 mg/kg single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV

Group Type: EXPERIMENTAL

LY3002813-IV

Intervention Type: BIOLOGICAL

Administered IV

LY3002813-Single 1 mg/kg in Healthy Participants

1 mg/kg single dose LY3002813 given once by IV infusion.

Group Type: EXPERIMENTAL

LY3002813-IV

Intervention Type: BIOLOGICAL

Administered IV

LY3002813-Single then multiple 1 mg/kg

1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV

Group Type: EXPERIMENTAL

LY3002813-IV

Intervention Type: BIOLOGICAL

Administered IV

LY3002813-Single then multiple 3 mg/kg

3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV

Group Type: EXPERIMENTAL

LY3002813-IV

Intervention Type: BIOLOGICAL

Administered IV

LY3002813-Single then multiple 10 mg/kg

10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV

Group Type: EXPERIMENTAL

LY3002813-IV

Intervention Type: BIOLOGICAL

Administered IV

Placebo-Single then multiple

Placebo given once, then every 4 weeks for up to 16 weeks IV

Group Type: PLACEBO_COMPARATOR

Placebo-IV

Intervention Type: DRUG

Administered IV

LY3002813-SC

Up to 3 mg/kg LY3002813 given once subcutaneously (SC)

Group Type: EXPERIMENTAL

LY3002813-SC

Intervention Type: BIOLOGICAL

Administered SC

LY3002813-IV

Up to 3mg/kg LY3002813 given once intravenously (IV)

Group Type: EXPERIMENTAL

LY3002813-IV

Intervention Type: BIOLOGICAL

Administered IV

Interventions

LY3002813-IV

Administered IV

Intervention Type: BIOLOGICAL

LY3002813-SC

Administered SC

Intervention Type: BIOLOGICAL

Placebo-IV

Administered IV

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Collaborative Neuroscience Network - CNS

Long Beach, California, United States

Compass Research

Orlando, Florida, United States

Atlanta Center of Medical Research

Atlanta, Georgia, United States

PRAHealthSciences

Salt Lake City, Utah, United States

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Sumida-Ku, , Japan

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.

Tokyo, , Japan

Countries

United States; Japan

Other Identifiers

I5T-MC-AACC

Identifier Type: OTHER

Identifier Source: secondary_id

15082

Identifier Type: -

Identifier Source: org_study_id