NCT05738486 · Phase 3 · ACTIVE NOT RECRUITING
A Study of Different Donanemab (LY3002813) Dosing Regimens in Adults With Early Alzheimer's Disease (TRAILBLAZER-ALZ 6)
This Phase 3 trial is testing whether different dosing schedules of donanemab — an anti-amyloid antibody already conditionally approved — can reduce the rate and severity of ARIA-E, a type of brain swelling that can occur as a side effect. Researchers also want to identify who is most at risk for ARIA. Phase 3 means the drug's basic effectiveness has been studied before; this round focuses on safety optimization across dosing strategies.
Eligibility criteria
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
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-11-14