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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04437511
Recruitment Status : Recruiting
First Posted : June 18, 2020
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 500 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
Estimated Primary Completion Date : March 9, 2023
Estimated Study Completion Date : April 11, 2024

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Donanemab
Donanemab given intravenously (IV).
Drug: Donanemab
Given IV
Other Name: LY3002813

Placebo Comparator: Placebo
Placebo given IV.
Drug: Placebo
Given IV




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change from Baseline on the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the MMSE Score

  2. 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

  3. Change from Baseline on the integrated Alzheimer's Disease Rating Scale (iADRS) [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the iADRS

  4. 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

  5. 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

  6. 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

  7. 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

  8. Pharmacokinetics (PK): Average Serum Concentration of Donanemab [ Time Frame: Baseline through Week 72 ]
    PK: Average Serum Concentration of Donanemab

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



Information from the National Library of Medicine

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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
  • 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

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


Contacts
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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

Locations
Show Show 86 study locations
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
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: August 4, 2020
Last Verified: August 2020
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
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