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A Study of Donanemab (LY3002813) Compared With Aducanumab in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 4)

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: NCT05108922
Recruitment Status : Active, not recruiting
First Posted : November 5, 2021
Last Update Posted : September 21, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
The main purpose of this study is to compare donanemab to aducanumab on amyloid plaque clearance in participants with early symptomatic Alzheimer's Disease (AD).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Disease Drug: Donanemab Drug: Aducanumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label, Parallel-Group, 2-Arm Study to Investigate Amyloid Plaque Clearance With Donanemab Compared With Aducanumab-avwa in Participants With Early Symptomatic Alzheimer's Disease
Actual Study Start Date : November 16, 2021
Actual Primary Completion Date : September 9, 2022
Estimated Study Completion Date : July 2, 2024


Arm Intervention/treatment
Experimental: Donanemab
Donanemab is administered intravenously (IV) every 4 weeks (Q4W)
Drug: Donanemab
Administered IV
Other Name: LY3002813

Active Comparator: Aducanumab
Aducanumab administered IV per label
Drug: Aducanumab
Administered IV




Primary Outcome Measures :
  1. Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 Positron Emission Tomography (PET) Scan (Superiority) on donanemab versus aducanumab [ Time Frame: 6 Months ]
    Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  2. Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: 6 Months ]
    Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the intermediate subpopulation (Superiority) on donanemab versus aducanumab


Secondary Outcome Measures :
  1. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 6 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  2. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 12 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  3. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 18 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  4. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months [ Time Frame: Baseline, 6 Months, 12 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) on donanemab 6 months versus aducanumab 12 months

  5. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months [ Time Frame: Baseline, 6 Months, 18 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Noninferiority) donanemab 6 months versus aducanumab 18 months

  6. Time to Reach Complete Amyloid Plaque Clearance on donanemab versus aducanumab [ Time Frame: Baseline to 18 Months ]
    Time to reach complete amyloid plaque clearance on donanemab versus aducanumab

  7. Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab [ Time Frame: Baseline, 6 Months ]
    Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) donanemab versus aducanumab

  8. Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 12 Months ]
    Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  9. Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 18 Months ]
    Mean Percent Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  10. Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: 12 Months ]
    Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  11. Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab [ Time Frame: 18 Months ]
    Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan (Superiority) on donanemab versus aducanumab

  12. Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: 12 Months ]
    Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab

  13. Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: 18 Months ]
    Percentage of Participants Who Reach Complete Amyloid Plaque Clearance on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab

  14. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 6 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab

  15. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 12 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab

  16. Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab [ Time Frame: Baseline, 18 Months ]
    Mean Absolute Change from Baseline in Brain Amyloid Plaque on Florbetapir F18 PET Scan in the Intermediate Tau Subpopulation (Superiority) on donanemab versus aducanumab

  17. Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months [ Time Frame: Baseline, 6 Months, 12 Months ]
    Change from Baseline in Brain Amyloid Plaque Reduction on Florbetapir F18 PET Scan (Superiority) donanemab 6 months versus aducanumab 12 months



Information from the National Library of Medicine

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:   50 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 the participant or informant for ≥6 months.
  • Meet florbetapir F18 PET scan criteria.
  • A Clinical Dementia Rating (CDR)-Global Score of 0.5 or 1.
  • Must consent to apolipoprotein E (ApoE) genotyping
  • Must have a mini mental state examination (MMSE) score between 20 and 30
  • Have a study partner who will provide written informed consent to participate, is in frequent contact with the participant (defined as at least 10 hours per week), and will accompany the participant to study visits or be available by telephone at designated times.
  • Have adequate literacy, vision, and hearing for neuropsychological testing in the opinion of the investigator at the time of screening.
  • Women not of childbearing potential may participate

Exclusion Criteria:

  • Significant neurological disease affecting the central nervous system (other than AD), that may affect cognition or ability to complete the study, including but not limited to, other dementias, serious infection of the brain, Parkinson's disease, multiple concussions, history of transient ischemic attack or stroke, or epilepsy or recurrent seizures (except febrile childhood seizures).
  • Current serious or unstable medical illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, psychiatric (including actively suicidal or deemed at risk of suicide, or current alcohol or substance abuse), immunologic, infectious, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study; or has a life expectancy of approximately

    ≤24 months.

  • History of clinically significant multiple or severe drug allergies, or severe posttreatment hypersensitivity reactions (including but not limited to erythema multiforme major, linear immunoglobulin A dermatosis, toxic epidermal necrolysis, and/or exfoliative dermatitis).
  • History of bleeding disorder or use of medications with platelet anti-aggregant or anti-coagulant properties (unless aspirin at ≤325 milligram (mg).
  • Have had prior or current treatment with donanemab or aducanumab
  • Have known allergies to donanemab or aducanumab, related compounds, or any components of the formulation
  • Prior or current participation in any immunotherapy study targeting Amyloid beta

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): NCT05108922


Locations
Show Show 31 study locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-2559) or 1-317-615-4559 Mon - Fri 9 am - 5 pm Eastern time (UTC/GMT) - 5 hours, EST) Eli Lilly and Company
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05108922    
Other Study ID Numbers: 18369
I5T-MC-AACN ( Other Identifier: Eli Lilly and Company )
First Posted: November 5, 2021    Key Record Dates
Last Update Posted: September 21, 2022
Last Verified: September 2022
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 European Union (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:
Mild Cognitive Impairment due to Alzheimer's Disease
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders