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

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: 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

Tracking Information
First Submitted Date  ICMJE August 27, 2021
First Posted Date  ICMJE August 30, 2021
Last Update Posted Date April 20, 2022
Actual Study Start Date  ICMJE August 27, 2021
Estimated Primary Completion Date October 25, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 27, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 27, 2021)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • Pharmacokinetics (PK): Average Serum Donanemab Concentration at Steady State [ Time Frame: Baseline through Week 76 ]
    PK: Average Serum Donanemab Concentration at Steady State
  • 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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Donanemab (LY3002813) Prevention Study in Participants With Alzheimer's Disease (TRAILBLAZER-ALZ 3)
Official Title  ICMJE A Study of Donanemab Versus Placebo in Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer Disease
Intervention  ICMJE
  • Drug: Donanemab
    Administered intravenously
    Other Name: LY3002813
  • Drug: Placebo
    Administered intravenously
Study Arms  ICMJE
  • Experimental: Donanemab
    Donanemab administered intravenously (IV)
    Intervention: Drug: Donanemab
  • Placebo Comparator: Placebo
    Placebo is administered intravenously
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 27, 2021)
3300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 8, 2027
Estimated Primary Completion Date October 25, 2027   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
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
Listed Location Countries  ICMJE Japan,   Puerto Rico,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05026866
Other Study ID Numbers  ICMJE 18284
I5T-MC-AACM ( Other Identifier: Eli Lilly and Company )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date April 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP