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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02624778
Recruitment Status : Completed
First Posted : December 8, 2015
Last Update Posted : June 12, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 4, 2015
First Posted Date  ICMJE December 8, 2015
Last Update Posted Date June 12, 2020
Actual Study Start Date  ICMJE December 22, 2015
Actual Primary Completion Date August 28, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
Florbetapir Positron Emission Tomography (PET) Standardized Uptake Value Ratio (SUVr) [ Time Frame: Predose up to Day 505 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 4, 2015)
  • Pharmacokinetics: Serum Concentrations of LY3002813 [ Time Frame: Predose up to Day 589 ]
  • Change from Baseline in Incidence of Anti-Drug Antibodies [ Time Frame: Predose up to Day 589 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of LY3002813 in Participants With Memory Damage Due to Alzheimer's Disease (AD) or AD
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Biological: LY3002813
    Administered IV
  • Drug: Placebo
    Administered IV
Study Arms  ICMJE
  • Experimental: LY3002813 Single dose 1
    LY3002813 administered intravenously (IV) once
    Intervention: Biological: LY3002813
  • Experimental: LY3002813 Single dose 2
    LY3002813 administered IV once
    Intervention: Biological: LY3002813
  • Experimental: LY3002813 Single dose 3
    LY3002813 administered IV once
    Intervention: Biological: LY3002813
  • Experimental: LY3002813 Multiple dose 1 x 24 wks
    LY3002813 administered IV for 24 wks
    Intervention: Biological: LY3002813
  • Experimental: LY3002813 Multiple dose 2 x 24 wks
    LY3002813 administered IV for 24 weeks
    Intervention: Biological: LY3002813
  • Experimental: LY3002813 Multiple dose 3 x 72 wks
    LY3002813 administered IV for 72 wks
    Intervention: Biological: LY3002813
  • Experimental: LY3002813 Multiple dose 4 x 72 weeks
    LY3002813 administered IV for 72 wks
    Intervention: Biological: LY3002813
  • Placebo Comparator: Placebo given once
    Placebo administered IV once
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo x 24 weeks
    Placebo administered IV for 24 wks
    Intervention: Drug: Placebo
  • Placebo Comparator: Placebo x 72 weeks
    Placebo administered IV for 72 wks
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
61
Original Estimated Enrollment  ICMJE
 (submitted: December 4, 2015)
150
Actual Study Completion Date  ICMJE August 28, 2019
Actual Primary Completion Date August 28, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02624778
Other Study ID Numbers  ICMJE 16233
I5T-MC-AACD ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: 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) Eli Lilly and Company
PRS Account Eli Lilly and Company
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP