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A Study of LY3002813 in Participants With Alzheimer's Disease

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3002813-IV
LY3002183-SC
Placebo-IV
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Alzheimer Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Collaborative Neuroscience Network - CNS
  • Compass Research
  • Atlanta Center of Medical Research
  • PRAHealthSciences
  • 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.
  • 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.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

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

LY3002813-Single then multiple 0.3 mg/kg

LY3002813-Single then multiple 1 mg/kg

LY3002813-Single then multiple 3 mg/kg

LY3002813-Single then multiple 10 mg/kg

Placebo-Single then multiple

LY3002813-SC

LY3002813-IV

Arm Description

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)

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

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

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

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

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

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

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

Outcomes

Primary Outcome Measures

Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Secondary Outcome Measures

Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3002813

Full Information

First Posted
April 18, 2013
Last Updated
December 21, 2017
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT01837641
Brief Title
A Study of LY3002813 in Participants With Alzheimer's Disease
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 Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
May 3, 2013 (Actual)
Primary Completion Date
August 24, 2016 (Actual)
Study Completion Date
August 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LY3002813-Single 0.1 mg/kg then multiple 0.3 mg/kg
Arm Type
Experimental
Arm Description
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)
Arm Title
LY3002813-Single then multiple 0.3 mg/kg
Arm Type
Experimental
Arm Description
0.3 mg/kg single dose then 0.3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Arm Title
LY3002813-Single then multiple 1 mg/kg
Arm Type
Experimental
Arm Description
1 mg/kg single dose then 1 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Arm Title
LY3002813-Single then multiple 3 mg/kg
Arm Type
Experimental
Arm Description
3 mg/kg single dose then 3 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Arm Title
LY3002813-Single then multiple 10 mg/kg
Arm Type
Experimental
Arm Description
10 mg/kg single dose then 10 mg/kg LY3002813 given every 4 weeks for up to 16 weeks IV
Arm Title
Placebo-Single then multiple
Arm Type
Placebo Comparator
Arm Description
Placebo given once, then every 4 weeks for up to 16 weeks IV
Arm Title
LY3002813-SC
Arm Type
Experimental
Arm Description
Up to 3 mg/kg LY3002813 given once subcutaneously (SC)
Arm Title
LY3002813-IV
Arm Type
Experimental
Arm Description
Up to 3mg/kg LY3002813 given once intravenously (IV)
Intervention Type
Biological
Intervention Name(s)
LY3002813-IV
Intervention Description
Administered IV
Intervention Type
Biological
Intervention Name(s)
LY3002183-SC
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo-IV
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Number of Participants With One or More Serious Adverse Events (SAEs) Considered by the Investigator to be Related to Study Drug Administration
Time Frame
Day 1 up to Day 253
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Maximum Concentration (Cmax) of LY3002813
Time Frame
Predose up to Day 253
Title
Pharmacokinetics: Area Under the Concentration Curve (AUC) of LY3002813
Time Frame
Predose up to Day 253

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
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)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
Collaborative Neuroscience Network - CNS
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Atlanta Center of Medical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
PRAHealthSciences
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
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.
City
Sumida-Ku
ZIP/Postal Code
130-0004
Country
Japan
Facility Name
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.
City
Tokyo
ZIP/Postal Code
162-0053
Country
Japan

12. IPD Sharing Statement

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A Study of LY3002813 in Participants With Alzheimer's Disease

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