NCT07571161 · Phase 3 · RECRUITING
Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease
This trial tests whether donanemab, an anti-amyloid drug given by IV infusion, slows memory and thinking decline compared with placebo. It enrolls Chinese adults with normal thinking whose blood tests suggest early Alzheimer's brain changes. It runs about three years. It is a Phase 3 trial: a large test of whether it works and is safe, not yet proven or approved for this use.
Eligibility criteria
Inclusion Criteria: * 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 * A reliable study partner who: * Provides written informed consent to participate in the study in their role * Has frequent contact with the participant and is familiar with their overall function and behavior, including daily activities and cognitive abilities * Is of legal age (18 years of age or older) to consent * Is available to conduct functional scales * Have adequate literacy, vision, and hearing for neuropsychological testing Exclusion Criteria: * 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 * Have any contraindications for magnetic resonance imaging (MRI), including claustrophobia or the presence of contraindicated metal (ferromagnetic) implants or other accessory medical devices, such as cardiac pacemakers, stents, and cochlear implants * Have a centrally read magnetic resonance imaging (MRI) demonstrating the presence of Amyloid-related imaging abnormalities (ARIA-E), more than 4 cerebral microhemorrhages, more than 1 area of cortical superficial siderosis, any macrohemorrhage (that is, intracerebral hemorrhage more than 1 cm), or severe white matter disease at screening
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 2026-08-24