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A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)

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ClinicalTrials.gov Identifier: NCT04437511
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : November 18, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Tracking Information
First Submitted Date  ICMJE June 17, 2020
First Posted Date  ICMJE June 18, 2020
Last Update Posted Date November 18, 2021
Actual Study Start Date  ICMJE June 19, 2020
Estimated Primary Completion Date February 14, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 3, 2021)
Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Up to Week 76 ]
Change from Baseline on the iADRS in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
Original Primary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Week 76 ]
Change from Baseline on the CDR-SB
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 3, 2021)
  • Change from Baseline on the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, Up to Week 76 ]
    Change from Baseline on the MMSE Score in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
  • Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: Baseline, Up to Week 76 ]
    Change from Baseline on the ADAS-Cog13 in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'
  • Change from Baseline on the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Up to Week 76 ]
    Change from Baseline on the CDR-SB in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
  • Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score [ Time Frame: Baseline, Up to Week 76 ]
    Change from Baseline on the ADCS-iADL Score in participants with early symptomatic AD in at least one of 'the low-medium tau pathology population or the overall population'.
  • Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Up to Week 76 ]
    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, Up to Week 76 ]
    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, Up to Week 76 ]
    Change from Baseline in Brain Volume as Measured by vMRI
  • Pharmacokinetics (PK): Average Serum Concentration at Steady State of Donanemab [ Time Frame: Baseline through Week 76 ]
    PK: Average Serum Concentration at steady state of Donanemab
  • Number or Participants with Anti-Donanemab Antibodies [ Time Frame: Baseline through Week 76 ]
    Number or Participants with Anti-Donanemab Antibodies
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2020)
  • Change from Baseline on the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the MMSE Score
  • Change from Baseline on the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13) [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the ADAS-Cog13
  • Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the iADRS
  • Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL) Score
  • Change from Baseline in Brain Amyloid Plaque Deposition as Measured by Florbetapir F18 Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Week 76 ]
    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, Week 76 ]
    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, Week 76 ]
    Change from Baseline in Brain Volume as Measured by vMRI
  • Pharmacokinetics (PK): Average Serum Concentration of Donanemab [ Time Frame: Baseline through Week 72 ]
    PK: Average Serum Concentration of Donanemab
  • Number or Participants with Anti-Donanemab Antibodies [ Time Frame: Baseline through Week 76 ]
    Number or Participants with Anti-Donanemab Antibodies
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Donanemab (LY3002813) in Participants With Early Alzheimer's Disease (TRAILBLAZER-ALZ 2)
Official Title  ICMJE Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Brief Summary

The reason for this study is to see how safe and effective the study drug donanemab is in participants with early Alzheimer's disease.

Additional participants will be enrolled to an addendum safety cohort. The participants will be administered open-label donanemab.

Detailed Description

TRAILBLAZER-ALZ 2 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of N3pG antibody (donanemab) in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.

Following the double-blind 76-week main study period, a double-blind 78-week long-term extension period is added to further evaluate donanemab efficacy and safety over time. Participants from the addendum safety cohort are not eligible for the extension period.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Donanemab
    Given IV
    Other Name: LY3002813
  • Drug: Placebo
    Given IV
Study Arms  ICMJE
  • Experimental: Donanemab
    Donanemab given intravenously (IV).
    Intervention: Drug: Donanemab
  • Placebo Comparator: Placebo
    Placebo given 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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 3, 2021)
1800
Original Estimated Enrollment  ICMJE
 (submitted: June 17, 2020)
500
Estimated Study Completion Date  ICMJE December 19, 2023
Estimated Primary Completion Date February 14, 2023   (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
  • Meet 18F flortaucipir PET scan (central read) criteria - does not apply to safety cohort
  • Meet 18F florbetapir PET scan (central read) criteria
  • Have a study partner who will provide written informed consent to participate

Exclusion Criteria:

  • Contraindication to MRI or PET scans
  • Current treatment with immunoglobulin G (IgG) therapy
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: 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
Listed Location Countries  ICMJE Australia,   Canada,   Czechia,   Japan,   Netherlands,   Poland,   Puerto Rico,   United Kingdom,   United States
Removed Location Countries France,   Germany
 
Administrative Information
NCT Number  ICMJE NCT04437511
Other Study ID Numbers  ICMJE 17737
I5T-MC-AACI ( Other Identifier: Eli Lilly and Company )
2020-000077-25 ( EudraCT Number )
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: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: http://vivli.org/
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 November 2021

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