Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age55-80
SponsorEli Lilly and Company

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

Treatment groups

140 Participants
are divided into 2 treatment groups

Locations

30
Peking University Third Hospital100191, Beijing China
The First Hospital of Jilin University100012, Changchun China
Xiangya Hospital Central South University410008, Changsha China
Sichuan Provincial People's Hospital610072, Chengdu China

Sponsors and collaborators

Eli Lilly and Company

Lead sponsor