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

STUDY OVERVIEW

This study sponsored by Eli Lilly aims to assess the safety and effectiveness of donanemab in individuals with preclinical Alzheimer's Disease (AD).

STUDY GOALS

This study investigates the safety and efficacy of donanemab in individuals diagnosed with preclinical Alzheimer's Disease (AD).

LOCATION

El Paso, Texas: ACNR

INCLUSION CRITERIA

• Cognitive function assessed with a modified Telephone Interview for Cognitive Status (TICS-M) indicating intact cognition.

• Phosphorylated tau (P-tau) result consistent with amyloid and early-tau pathology.

• Reliable study partner familiar with overall function and behavior.

• Adequate literacy, vision, and hearing for neuropsychological testing.

• Contraceptive use consistent with local regulations.

• Female participants meeting infertility criteria or post-menopausal status.

EXCLUSION CRITERIA

• Mild cognitive impairment, dementia, or other significant neurodegenerative diseases.

• Serious or unstable illnesses with life expectancy ≤5 years.

• History of cancer with high recurrence risk.

• Severe drug allergies or hypersensitivity reactions.

• Clinically significant abnormalities on MRI or lab tests.

• Contraindications for MRI.

• Imaging abnormalities indicating potential risk.

• Recent treatment with anti-amyloid therapy.

• Previous active immunization against amyloid beta.

• Current or past use of medications for mild cognitive impairment or Alzheimer's disease.

For more information, visit ClinicalTrials.gov.