About this trial
The main purpose of this study is to evaluate the effects of donanemab (LY3002813) versus placebo in Chinese participants who are at risk for decline of memory, language and physical ability to perform activities of daily living from Alzheimer's disease (AD).
The study drug will be administered intravenously (IV) (into a vein in the arm).
The study will last up to approximately 156 weeks, excluding screening.
Eligibility criteria
Qualifiers
A Telephone Interview for Cognitive Status - Modified (TICS-M) score indicative of intact cognitive function (cut-off score of 35 or higher)
Clinical Dementia Rating-Global Score (CDR-GS) of 0
A plasma P-tau result consistent with amyloid pathology
Provides written informed consent to participate in the study in their role
Disqualifiers
Have mild cognitive impairment (MCI), dementia, or other significant neurodegenerative diseases that could affect cognition
Have a serious or unstable illness (including cardiovascular, hepatic, renal, gastrointestinal, respiratory, endocrinologic, neurologic, psychiatric, immunologic, or hematologic disease, or other condition) that, in the investigator's opinion, could interfere with study analyses or result in a life expectancy of 5 years or fewer
Have received active or passive immunization against amyloid beta (Aβ) in any other study
Have current or prior use of prescription medications for treatment of MCI or AD
Trial design
Treatments tested in this trial
- Donanemab
- Placebo