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A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)

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ClinicalTrials.gov Identifier: NCT05026866
Recruitment Status : Recruiting
First Posted : August 30, 2021
Last Update Posted : April 20, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The main purpose of this study is to evaluate the safety and efficacy of donanemab in participants with preclinical Alzheimer's Disease (AD).

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
Actual Study Start Date : August 27, 2021
Estimated Primary Completion Date : October 25, 2027
Estimated Study Completion Date : November 8, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Donanemab
Donanemab administered intravenously (IV)
 Drug: Donanemab
Administered intravenously
Other Name: LY3002813
Placebo Comparator: Placebo
Placebo is administered intravenously
 Drug: Placebo
Administered intravenously


Outcome Measures
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Primary Outcome Measures :
  1. Time to clinical progression as measured by Clinical Dementia Rating - Global Score (CDR-GS) [ Time Frame: Estimated Up to Week 182 ]
    Time to clinical progression as measured by CDR-GS. CDR is a clinician-rated scale that provides an overall assessment of the participant's stage on the spectrum of AD dementia.


Secondary Outcome Measures :
  1. Change from Baseline in International Shopping List Test (ISLT) [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by ISLT in participants with preclinical AD.

  2. Change from Baseline in Continuous Paired Associate Learning (CPAL) [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by CPAL in participants with preclinical AD.

  3. Change from Baseline in International Daily Symbol Substitution Test-Medicines (iDSSTm) [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by iDSSTm in participants with preclinical AD.

  4. Change from Baseline in Category Fluency [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by Category Fluency in participants with preclinical AD.

  5. Change from Baseline in Face Name Association Test (FNAME) [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by FNAME in participants with preclinical AD.

  6. Change from Baseline in Behavioral Pattern Separation-Object test (BPS-O) [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by BPS-O in participants with preclinical AD.

  7. Change from Baseline in Cogstate Brief Battery (CBB) [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by CBB in participants with preclinical AD.

  8. Change from Baseline in CDR-Sum of Boxes (CDR-SB) [ Time Frame: Baseline, Up Week 32 ]
    Change from Baseline in clinical progression as measured by CDR-SB in participants with preclinical AD.

  9. Change from Baseline in Cognitive Function Index (CFI) [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by CFI in participants with preclinical AD.

  10. Change from Baseline in Montreal Cognitive Assessment (MoCA) score [ Time Frame: Baseline, Up to Week 182 ]
    Change from Baseline in clinical progression as measured by MoCA score in participants with preclinical AD.

  11. Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State [ Time Frame: Baseline through Week 76 ]
    PK: Average Serum Donanemab Concentration at Steady State

  12. Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs) [ Time Frame: Baseline through Week 16 ]
    Percentage of Participants with Treatment-emergent Anti-Drug Antibody (ADAs)


Eligibility Criteria
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Ages Eligible for Study:   55 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A Telephone Interview for Cognitive Status - modified (TICS-M) score reflective of intact cognitive functioning.
  • Has a phosphorylated tau (P-tau) result consistent with the presence of amyloid and early-tau pathology.
  • Has a reliable study partner and backup study partner familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.
  • Have adequate literacy, vision, and hearing for neuropsychological testing at screening.
  • Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies
  • Female participants include those who are infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as Mullerian agenesis; or post menopausal (women 55 or older not on hormone therapy and had at least 12 months of spontaneous amenorrhea; or with a diagnosis of menopause prior to starting hormone replacement therapy.

Exclusion Criteria:

  • Mild cognitive impairment or dementia, or significant other neurodegenerative disease that can affect cognition.
  • Current serious or unstable illnesses including cardiovascular, hepatic, renal, gastroenterologic, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease that could interfere with the analysis of the study or a life expectancy of approximately ≤5 years.
  • History of cancer with high risk of recurrence and preventing completion of the trial.
  • 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).
  • Have any clinically important abnormality at screening on magnetic resonance imaging (MRI) or clinical laboratory test results that could be detrimental to the participant or study integrity.
  • Have any contraindications for MRI, including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants/cardiac pacemaker.
  • Have a centrally read MRI demonstrating presence of amyloid-related imaging abnormalities (ARIA-E), >4 cerebral microhemorrhages, more than 1 area of superficial siderosis, any macrohemorrhage or severe white matter disease at screening.
  • Have had prior treatment with a passive anti-amyloid immunotherapy <5 half-lives prior to randomization.
  • Have received active immunization against amyloid beta (Aβ) in any other study.
  • Have received active immunization against Aβ in any other study.
  • Current or previous use of prescription medications used as treatment for mild cognitive impairment (MCI) or AD.
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): NCT05026866


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: NCT05026866    
Other Study ID Numbers: 18284
I5T-MC-AACM ( Other Identifier: Eli Lilly and Company )
First Posted: August 30, 2021    Key Record Dates
Last Update Posted: April 20, 2022
Last Verified: April 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
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