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A Study of Donanemab (LY3002813) in Participants With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-ALZ 5)

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: NCT05508789
Recruitment Status : Recruiting
First Posted : August 19, 2022
Last Update Posted : March 27, 2023
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 assess the safety and efficacy of donanemab in participants with early Alzheimer's disease. The study duration including screening and follow-up is up to 93 weeks.

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

Detailed Description:
TRAILBLAZER-ALZ 5 is a Phase 3, double-blind, placebo-controlled study to evaluate the safety and efficacy of donanemab in participants with early symptomatic AD (prodromal AD and mild dementia due to AD) with the presence of brain tau pathology.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Global Study to Investigate Safety and Efficacy of Donanemab in Early Symptomatic Alzheimer's Disease
Actual Study Start Date : October 10, 2022
Estimated Primary Completion Date : April 16, 2027
Estimated Study Completion Date : June 11, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Donanemab
Participants will receive donanemab intravenously (IV)
 Drug: Donanemab
Administered IV
Other Name: (LY3002813)
Placebo Comparator: Placebo
Participants will receive placebo IV
 Drug: Placebo
Administered 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, Week 76 ]
    Change from Baseline on the iADRS in at least one of 'the low-medium tau pathology population or the overall population'.


Secondary 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 CDR-SB 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 Score [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the ADAS-Cog13 Score in at least one of 'the low-medium tau pathology population or the overall population'.

  3. 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 ADCS-iADL Score in at least one of 'the low-medium tau pathology population or the overall population'.

  4. Change from Baseline on the Mini Mental State Examination (MMSE) Score [ Time Frame: Baseline, Week 76 ]
    Change from Baseline on the MMSE Score in at least one of 'the low-medium tau pathology population or the overall population'.

  5. Change from Baseline in Amyloid Plaque Deposition as by Florbetapir F18 Positron Emission Tomography (PET) Scan [ Time Frame: Baseline, Week 76 ]
  6. Pharmacokinetics (PK): Average Serum Concentration of Donanemab [ Time Frame: Baseline to Week 76 ]
  7. Number of Participants with Treatment-Emergent Anti-Drug Antibodies (ADAs) [ Time Frame: Week 76 ]
  8. Change from Baseline in Quality of Life in Alzheimer's Disease (QOL-AD) [ Time Frame: Baseline, Week 76 ]
    Change from baseline in the QoL-AD in at least one of 'the low-medium tau pathology population or the overall population'.

  9. Change from Baseline in Resource Utilization in Dementia - Lite Version (RUD-Lite) [ Time Frame: Baseline, Week 76 ]
    Change from baseline in the RUD-Lite in at least one of 'the low-medium tau pathology population or the overall population'.

  10. Change from Baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: Baseline, Week 76 ]
    Change from baseline in the NPI in at least one of 'the low-medium tau pathology population or the overall population'.


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 MMSE score of 20 to 28 (inclusive) at Day 601 or 1.
  • Meet flortaucipir F18 scan (central read) criteria
  • Meet florbetapir F18 scan (central read) criteria
  • 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 the study or be available by telephone at designated times.
  • A second study partner may serve as backup. The study partner(s) is/are required to accompany the participant for signing consent. The study partner must be present on all days the cognitive and functional scales are administered.
  • If a participant has a second study partner, it is preferred that 1 study partner be primarily responsible for the CDR and the ADCS-ADL assessments.

  • Days requiring the following assessments and scales must have a study partner available by telephone if not accompanying participant for the following assessments

    • AEs and concomitant medications
    • CDR, and
    • ADCS-ADL
  • Stable concomitant symptomatic AD medications and other medications that may impact cognition for at least approximately 30 days prior to randomization.

Exclusion Criteria:

  • Has significant neurological disease affect 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; or has a life expectancy of <24 months.
  • History of cancer within the last 5 years, except of non-metastatic basal and/or squamous cell carcinoma of the skin, in situ cervical cancer, nonprogressive prostate cancer, or other cancers with low risk of recurrence or spread.
  • Contraindication to MRI or PET scans
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): NCT05508789


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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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05508789    
Other Study ID Numbers: 18442
I5T-MC-AACO ( Other Identifier: Eli Lilly and Company )
2021-006395-17 ( EudraCT Number )
First Posted: August 19, 2022    Key Record Dates
Last Update Posted: March 27, 2023
Last Verified: March 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
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
Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
 Tauopathies
Disease
Mental Disorders
Neurocognitive Disorders
Pathologic Processes