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

Not Recruiting
60 - 85 years of age
Both
Phase 3

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Overview

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.

Eligibility

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
  • 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
    • Contraindication to MRI or PET scans
    • Have had prior treatment with a passive anti-amyloid immunotherapy.

Study details

Alzheimer's Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases

NCT05738486

Eli Lilly and Company

24 January 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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