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A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)

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: NCT05738486
Recruitment Status : Recruiting
First Posted : February 22, 2023
Last Update Posted : May 23, 2023
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This study will investigate different donanemab dosing regimens and their effect on the frequency and severity of ARIA-E in adults with early symptomatic Alzheimer's disease (AD) and explore participant characteristics that might predict risk of ARIA.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Drug: Donanemab Drug: Placebo Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase 3b
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
Actual Study Start Date : February 28, 2023
Estimated Primary Completion Date : March 19, 2024
Estimated Study Completion Date : May 13, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Donanemab Dose Level 1

Participants will receive donanemab by intravenously (IV) infusion.

Participants will receive placebo at certain intervals to preserve the blind.

 Drug: Donanemab
Administered IV
Other Name: LY3002813

Drug: Placebo
Administered IV
Experimental: Donanemab Dose Level 2

Participants will receive donanemab by IV infusion.

Participants will receive placebo at certain intervals to preserve the blind.

 Drug: Donanemab
Administered IV
Other Name: LY3002813

Drug: Placebo
Administered IV
Experimental: Donanemab Dose Level 3

Participants will receive donanemab by IV infusion.

Participants will receive placebo at certain intervals to preserve the blind.

 Drug: Donanemab
Administered IV
Other Name: LY3002813

Drug: Placebo
Administered IV
Experimental: Donanemab Dose Level 4

Participants will receive donanemab by IV infusion.

Participants will receive placebo at certain intervals to preserve the blind.

 Drug: Donanemab
Administered IV
Other Name: LY3002813

Drug: Placebo
Administered IV


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants with Any Occurence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E) [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :
  1. Percentage of Participants with Any Occurence of ARIA-E [ Time Frame: 52 Weeks ]
  2. Change from Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, 76 Weeks ]
  3. Percentage of Participants with Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H) [ Time Frame: 24 Weeks ]
  4. Percentage of Participants with ARIA-H [ Time Frame: 52 Weeks ]
  5. Percentage of Participants with Maximum Severity of ARIA-E or ARIA-H [ Time Frame: 52 Weeks ]
  6. Pharmacokinetics (PK): Average Serum Concentration of Donanemab [ Time Frame: Baseline to 52 Weeks ]
  7. Number of Participants with Anti-Drug Antibodies (ADAs) Against Donanemab, including Treatment Emergent ADAs and Neutralizing Antibodies [ Time Frame: Baseline to End of Follow-Up (91 Weeks) ]

Eligibility Criteria
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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 the participant or informant for ≥6 months.
  • A mini mental state examination (MMSE) score of 20 to 28 (inclusive) at screening.
  • Have an amyloid PET scan result from central read, consistent with the presence of amyloid pathology.

Exclusion Criteria:

  • Have 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, or epilepsy or recurrent seizures, except febrile childhood seizures.
  • Has current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic (other than AD), psychiatric, immunologic, or hematologic disease and other conditions that, in the investigator's opinion, could interfere with the analyses in this study.
  • A life expectancy of <24 months
  • Have a presence or history of malignant neoplasms within the past 5 years prior to Visit 1.

Exceptions:

  • non-metastatic basal- or squamous-cell skin cancer
  • Stage 0 non-invasive carcinoma of the cervix
  • Stage 0 non-invasive prostate cancer, or

  • other cancers with low risk of recurrence or spread

    • Contraindication to MRI or PET scans
    • Have had prior treatment with a passive anti-amyloid immunotherapy.
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): NCT05738486


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
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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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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05738486    
Other Study ID Numbers: 18648
I5T-MC-AACQ ( Other Identifier: Eli Lilly and Company )
2022-502268-18-00 ( Other Identifier: EU Trial Number )
U1111-1285-9438 ( Other Identifier: UTN Number )
First Posted: February 22, 2023    Key Record Dates
Last Update Posted: May 23, 2023
Last Verified: May 7, 2023
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
Additional relevant MeSH terms:
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Alzheimer Disease
Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Disease
 Mental Disorders
Neurocognitive Disorders
Pathologic Processes
Dementia
Tauopathies