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Trial record 1 of 1 for:    I5T-MC-AACG
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A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

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: NCT03367403
Recruitment Status : Active, not recruiting
First Posted : December 8, 2017
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE December 5, 2017
First Posted Date  ICMJE December 8, 2017
Last Update Posted Date February 5, 2020
Actual Study Start Date  ICMJE December 18, 2017
Estimated Primary Completion Date December 11, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
Change from Baseline in the Integrated Alzheimer's Disease Rating Scale (iADRS) Score [ Time Frame: Baseline, 18 Months ]
Change from baseline in the iADRS score
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 5, 2017)
  • Change from Baseline in the Alzheimer's Disease Assessment Scale—Cognitive Subscale (ADAS-Cog13) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the ADAS-Cog13 score
  • Change from Baseline in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the CDR-SB score
  • Change from Baseline in the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the MMSE score
  • Change from Baseline in Alzheimer's Disease Cooperative Study-Instrumental Activities of Daily Living Scale (ADCS-iADL) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the ADCS-iADL score
  • Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, 18 Months ]
    Change from baseline in brain amyloid plaque deposition as measured by Florbetapir F18 PET scan
  • Change from Baseline in Brain Tau Deposition as Measured by Flortaucipir F18 PET Scan [ Time Frame: Baseline, 18 Months ]
    Change from baseline in brain tau deposition as measured by flortaucipir F18 PET scan
  • Change from Baseline in Brain Volume as Measured by volumetric Magnetic Resonance Imaging (vMRI) [ Time Frame: Baseline, 18 Months ]
    Change from Baseline in Brain Volume as Measured by vMRI
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 Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)
Official Title  ICMJE Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease
Brief Summary The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: LY3002813
    Administered IV
  • Drug: Placebo
    Administered IV
Study Arms  ICMJE
  • Experimental: LY3002813
    LY3002813 administered intravenously (IV).
    Intervention: Drug: LY3002813
  • Placebo Comparator: Placebo
    Placebo administered IV.
    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 Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: October 18, 2018)
266
Original Estimated Enrollment  ICMJE
 (submitted: December 5, 2017)
375
Estimated Study Completion Date  ICMJE November 12, 2021
Estimated Primary Completion Date December 11, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Gradual and progressive change in memory function reported by participants or informants for ≥ 6 months.
  • MMSE score of 20 to 28 (inclusive) at baseline or an acceptable historical flortaucipir PET scan within 6 months prior to baseline that meets the central read criteria.
  • Meet 18F flortaucipir PET scan criteria.
  • Meet 18F florbetapir PET scan (central read) criteria.

Exclusion Criteria:

  • Have a history of long QT syndrome.
  • Have received treatment with a stable dose of an acetylcholinesterase inhibitor (AChEI) and/or memantine for less than 2 months before randomization.
  • Contraindication to MRI.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years to 85 Years   (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 Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03367403
Other Study ID Numbers  ICMJE 16933
I5T-MC-AACG ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description:

Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.

This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.

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 February 1, 2020

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