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Active, Not Recruiting

NCT Number: NCT05738486

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Re:Cognition Health - Bristol, Bristol, Bristol, City of, United Kingdom

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • 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

Treatment and study plan

Donanemab

Drug

Administered IV

Other names: LY3002813

Placebo

Drug

Administered IV

Dexamethasone

Drug

Administered IV

Primary outcomes

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

    Time frame: 24 Weeks

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

Secondary outcomes

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

    Time frame: 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

    Time frame: 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)

    Time frame: 24 Weeks

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

  4. Percentage of Participants With ARIA-H

    Time frame: 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

    Time frame: 76 Weeks

    Outcome data will be provided after the study is completed.

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

    Time frame: 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

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

    Outcome data will be provided after the study is completed.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Investigating the Effect of Different Donanemab Dosing Regimens on ARIA-E and Amyloid Lowering in Adults With Early Symptomatic Alzheimer's Disease

Important dates

Study start
2023
Primary completion
2024
Study completion
2027
First posted
Feb 22, 2023
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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