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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 : Active, not recruiting
First Posted : June 18, 2020
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.


Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: Donanemab Drug: Placebo Phase 3

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 amyloid and 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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1736 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Assessment of Safety, Tolerability, and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Actual Study Start Date : June 19, 2020
Actual Primary Completion Date : April 14, 2023
Estimated Study Completion Date : August 22, 2025

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Donanemab
Participants received 700 milligram (mg) Donanemab every 4 weeks (Q4W) x 3 doses, then 1400 mg Q4W given intravenously (IV) for up to 72 weeks
 Drug: Donanemab
Given IV
Other Name: LY3002813
Placebo Comparator: Placebo
Participants received placebo given IV.
 Drug: Placebo
Given IV


Outcome Measures
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Primary Outcome Measures :
  1. 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'.


Secondary Outcome Measures :
  1. 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'.

  2. 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'

  3. 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'.

  4. 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'.

  5. 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

  6. 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

  7. 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

  8. 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

  9. Number or Participants with Anti-Donanemab Antibodies [ Time Frame: Baseline through Week 76 ]
    Number or Participants with Anti-Donanemab Antibodies


Eligibility Criteria
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Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
  • 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
Contacts and Locations
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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): NCT04437511


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04437511    
Other Study ID Numbers: 17737
I5T-MC-AACI ( Other Identifier: Eli Lilly and Company )
2020-000077-25 ( EudraCT Number )
First Posted: June 18, 2020    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
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
Statistical Analysis Plan (SAP)
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/

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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:
Alzheimer's
Dementia
Cognitive Impairment
Amyloid Plaque
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders