A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD
NCT ID: NCT02624778
Last Updated: 2024-10-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
61 participants
INTERVENTIONAL
2015-12-22
2019-08-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
TRIPLE
Study Groups
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Part A: Placebo Single Dose (SD)
Participants received single intravenous (IV) dose of placebo.
Placebo
Administered IV
Part A: 10 Milligram Per Kilogram (mg/kg) LY3002813 SD
Participants received single IV dose of 10 mg/kg LY3002813.
LY3002813
Administered IV
Part A: 20 mg/kg LY3002813 SD
Participants received single IV dose of 20 mg/kg LY3002813.
LY3002813
Administered IV
Part A: 40 mg/kg LY3002813 SD
Participants received single IV dose of 40 mg/kg LY3002813.
LY3002813
Administered IV
Part B: Placebo Q2W
Participants received multiple IV dose of placebo every 2 weeks (Q2W) for 24 weeks.
Placebo
Administered IV
Part B: 10 mg/kg LY3002813 Q2W
Participants received multiple IV dose of 10 mg/kg LY3002813 Q2W for 24 weeks.
LY3002813
Administered IV
Part C: Placebo Q4W
Participants received multiple IV dose of placebo every 4 weeks (Q4W) for 72 weeks.
Placebo
Administered IV
Part C:10 mg/kg LY3002813 Q4W
Participants received multiple IV dose of 10 mg/kg LY3002813 Q4W for 72 weeks.
LY3002813
Administered IV
Part C:20 mg/kg LY3002813 Q4W
Participants received multiple IV dose of 20 mg/kg LY3002813 Q4W for 72 weeks.
LY3002813
Administered IV
Interventions
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LY3002813
Administered IV
Placebo
Administered IV
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
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Brain Matters Research
Delray Beach, Florida, United States
Compass Research
Orlando, Florida, United States
Compass Research
The Villages, Florida, United States
SNBL Clinical Pharmacology Center Inc
Baltimore, Maryland, United States
St. Louis Clinical Trials, LC
St Louis, Missouri, United States
PRA Health Sciences
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.
Shinjuku-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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Shinjuku-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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
Sumida-ku, , Japan
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Click here for more information about this study: A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD)
Other Identifiers
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I5T-MC-AACD
Identifier Type: OTHER
Identifier Source: secondary_id
16233
Identifier Type: -
Identifier Source: org_study_id
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