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A Study of LY3002813 in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ)

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ClinicalTrials.gov Identifier: NCT03367403
Recruitment Status : Recruiting
First Posted : December 8, 2017
Last Update Posted : October 19, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The purpose of this study is to evaluate the safety, tolerability and efficacy of LY3002813 in early symptomatic Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: LY3002813 Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Safety, Tolerability and Efficacy of LY3002813 in Early Symptomatic Alzheimer's Disease
Actual Study Start Date : December 18, 2017
Estimated Primary Completion Date : October 15, 2020
Estimated Study Completion Date : September 16, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LY3002813
LY3002813 administered intravenously (IV).
Drug: LY3002813
Administered IV

Placebo Comparator: Placebo
Placebo administered IV.
Drug: Placebo
Administered IV




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Change from Baseline in the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, 18 Months ]
    Change from baseline in the MMSE score

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03367403


Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 ClinicalTrials.gov@lilly.com

  Show 69 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03367403     History of Changes
Other Study ID Numbers: 16933
I5T-MC-AACG ( Other Identifier: Eli Lilly and Company )
First Posted: December 8, 2017    Key Record Dates
Last Update Posted: October 19, 2018
Last Verified: October 17, 2018
Individual Participant Data (IPD) Sharing Statement:
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.


Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Eli Lilly and Company:
TRAILBLAZER-ALZ

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders