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

NCT05738486
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
1,175
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Lead sponsor
Eli Lilly and Company
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Start date
2023-02-28
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Number of sites
49
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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. Approximately 375 additional participants will be enrolled in addendum 2. Addendum 3 includes a subset of participants from the main study to receive a single dose. The study will last approximately 91 weeks and include up to 26 visits in the main study.
clinicaltrials.gov
Short title
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
clinicaltrials.gov
Official title
Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease
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Registry reports results
Yes
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-05-01
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First posted
2023-02-22
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Registry last updated
2026-06-18
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Primary completion date
2024-05-16
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Start date
2023-02-28
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Actual participants
1,175
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Participants
1,175
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Participant count basis
Actual
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Protocol amendments
5
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Number of sites
49
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Eli Lilly and Company
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05738486
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ClinicalTrials.gov ID
NCT05738486
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Edema/Effusion (ARIA-E)

    Timeframe: 24 Weeks

    Percentage of participants with occurrence of ARIA-E at Week 24 is reported here.

  1. Percentage of Participants With Any Occurrence of ARIA-E

    Timeframe: 52 Weeks

    Outcome data will be provided after the study is completed.

  2. Change From Baseline in Brain Amyloid Plaque Deposition As Measured By Amyloid Positron Emission Tomography (PET) Scan

    Timeframe: Baseline, 76 Weeks

    Outcome data will be provided after the study is completed.

  3. Percentage of Participants With Any Occurrence of Amyloid-Related Imaging Abnormality-Hemorrhage/Hemosiderin Deposits (ARIA-H)

    Timeframe: 24 Weeks

    Percentage of participants with occurrence of ARIA-H at Week 24 is reported here.

  4. Percentage of Participants With ARIA-H

    Timeframe: 52 Weeks

    Outcome data will be provided after the study is completed.

  5. Percentage of Participants With Maximum Severity of ARIA-E or ARIA-H

    Timeframe: 76 Weeks

    Outcome data will be provided after the study is completed.

  6. Pharmacokinetics (PK): Average Serum Concentration of Donanemab

    Timeframe: Baseline to 76 Weeks

    Outcome data will be provided after the study is completed.

  7. Number of Participants With Anti-Drug Antibodies (ADAs) Against Donanemab, Including Treatment Emergent ADAs and Neutralizing Antibodies

    Timeframe: Baseline to End of Follow-Up (91 Weeks)

    Outcome data will be provided after the study is completed.

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
60 Years
Maximum age
85 Years
Healthy volunteers
No

  • 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.

  • 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.
  • Contraindication to MRI or PET scans
  • Have had prior treatment with a passive anti-amyloid immunotherapy.
  • 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
Sources for eligibility
clinicaltrials.gov

  • MD First Research - ChandlerChandler, United States
  • Irvine Clinical ResearchIrvine, United States
  • Healthy Brain ClinicLong Beach, United States
  • California Neuroscience Research Medical Group, Inc.Sherman Oaks, United States
  • JEM Research InstituteAtlantis, United States
  • VIN-Julie SchwartzbardAventura, United States
  • Excel Medical Clinical TrialsBoca Raton, United States
  • K2 Medical ResearchClermont, United States
  • Brain Matters ResearchDelray Beach, United States
  • Neuropsychiatric Research Center of Southwest FloridaFort Myers, United States
  • Finlay Medical ResearchGreenacres City, United States
  • Infinity Clinical Research, LLCHollywood, United States
  • Jacksonville Center for Clinical ResearchJacksonville, United States
  • ClinCloud - MaitlandMaitland, United States
  • K2 Medical ResearchMaitland, United States
  • ClinCloud - VieraMelbourne, United States
  • Suncoast Clinical Research, Inc.New Port Richey, United States
  • Renstar Medical ResearchOcala, United States
  • Charter Research - Winter ParkOrlando, United States
  • Progressive Medical ResearchPort Orange, United States
  • Alzheimer's Research and Treatment CenterStuart, United States
  • K2 Medical Research - TampaTampa, United States
  • K2 Summit ResearchThe Villages, United States
  • Charter Research - Lady LakeThe Villages, United States
  • Alzheimer's Research and Treatment CenterWellington, United States

And 24 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • U1111-1285-9438
  • 2022-502268-18-00
  • I5T-MC-AACQ
Sources for references
clinicaltrials.gov

Related records

Drugs (2)

Lead sponsors (1)

Conditions (6)

Targets (2)