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A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
LY3002813
Placebo
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

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Present with mild cognitive impairment (MCI) due to Alzheimer's disease (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 up to 2 partners who will provide 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:

  • Do not have up to 2 reliable partners who are 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 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
  • Have current serious or unstable illnesses

Sites / Locations

  • Brain Matters Research
  • Compass Research
  • Compass Research
  • SNBL Clinical Pharmacology Center Inc
  • St. Louis Clinical Trials, LC
  • PRA Health Sciences
  • 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, 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, 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 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Placebo Comparator

Placebo Comparator

Arm Label

LY3002813 Single dose 1

LY3002813 Single dose 2

LY3002813 Single dose 3

LY3002813 Multiple dose 1 x 24 wks

LY3002813 Multiple dose 2 x 24 wks

LY3002813 Multiple dose 3 x 72 wks

LY3002813 Multiple dose 4 x 72 weeks

Placebo given once

Placebo x 24 weeks

Placebo x 72 weeks

Arm Description

LY3002813 administered intravenously (IV) once

LY3002813 administered IV once

LY3002813 administered IV once

LY3002813 administered IV for 24 wks

LY3002813 administered IV for 24 weeks

LY3002813 administered IV for 72 wks

LY3002813 administered IV for 72 wks

Placebo administered IV once

Placebo administered IV for 24 wks

Placebo administered IV for 72 wks

Outcomes

Primary Outcome Measures

Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)

Secondary Outcome Measures

Pharmacokinetics: Serum Concentrations of LY3002813
Change from Baseline in Incidence of Anti-Drug Antibodies

Full Information

First Posted
December 4, 2015
Last Updated
June 10, 2020
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT02624778
Brief Title
A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD
Official Title
A Single- and Multiple-Dose Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single and Multiple Intravenous Doses 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
June 2020
Overall Recruitment Status
Completed
Study Start Date
December 22, 2015 (Actual)
Primary Completion Date
August 28, 2019 (Actual)
Study Completion Date
August 28, 2019 (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 effect of LY3002813 on brain scans. The study will evaluate the safety of LY3002813 by looking at adverse events (side effects). The study will also look at the effect the body has on LY3002813. Study participants will have mild cognitive impairment (MCI) due to AD or mild to moderate AD. The study involves 3 parts. Part A in which participants will receive a single dose of LY3002813 or placebo (no drug). Part B in which participants will receive multiple doses of LY3002813 or placebo for 24 weeks. Part C in which participants will receive multiple doses of LY3002813 or placebo for up to 72 weeks. Drug will be given as an intravenous infusion (injection into a vein). For Parts A, B and C, the study will last approximately 72 weeks, not including screening of approximately 56 days. The study is for research purposes only and is not intended to treat any medical condition.

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
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
61 (Actual)

8. Arms, Groups, and Interventions

Arm Title
LY3002813 Single dose 1
Arm Type
Experimental
Arm Description
LY3002813 administered intravenously (IV) once
Arm Title
LY3002813 Single dose 2
Arm Type
Experimental
Arm Description
LY3002813 administered IV once
Arm Title
LY3002813 Single dose 3
Arm Type
Experimental
Arm Description
LY3002813 administered IV once
Arm Title
LY3002813 Multiple dose 1 x 24 wks
Arm Type
Experimental
Arm Description
LY3002813 administered IV for 24 wks
Arm Title
LY3002813 Multiple dose 2 x 24 wks
Arm Type
Experimental
Arm Description
LY3002813 administered IV for 24 weeks
Arm Title
LY3002813 Multiple dose 3 x 72 wks
Arm Type
Experimental
Arm Description
LY3002813 administered IV for 72 wks
Arm Title
LY3002813 Multiple dose 4 x 72 weeks
Arm Type
Experimental
Arm Description
LY3002813 administered IV for 72 wks
Arm Title
Placebo given once
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV once
Arm Title
Placebo x 24 weeks
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV for 24 wks
Arm Title
Placebo x 72 weeks
Arm Type
Placebo Comparator
Arm Description
Placebo administered IV for 72 wks
Intervention Type
Biological
Intervention Name(s)
LY3002813
Intervention Description
Administered IV
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered IV
Primary Outcome Measure Information:
Title
Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr)
Time Frame
Predose up to Day 505
Secondary Outcome Measure Information:
Title
Pharmacokinetics: Serum Concentrations of LY3002813
Time Frame
Predose up to Day 589
Title
Change from Baseline in Incidence of Anti-Drug Antibodies
Time Frame
Predose up to Day 589

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Present with mild cognitive impairment (MCI) due to Alzheimer's disease (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 up to 2 partners who will provide 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: Do not have up to 2 reliable partners who are 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 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 Have current serious or unstable illnesses
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
Brain Matters Research
City
Delray Beach
State/Province
Florida
ZIP/Postal Code
33445
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Compass Research
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
SNBL Clinical Pharmacology Center Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
St. Louis Clinical Trials, LC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
PRA Health Sciences
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
Shinjuku-Ku
ZIP/Postal Code
162-0053
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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Shinjuku-Ku
ZIP/Postal Code
169-0073
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, 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

12. IPD Sharing Statement

Learn more about this trial

A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD

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