Donanemab in Chinese adults at risk for Alzheimer’s decline

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial evaluates donanemab (LY3002813) given by IV infusion versus placebo in Chinese participants who are at risk of memory and functional decline related to Alzheimer’s disease but currently have normal global cognition. Eligible participants have intact cognition by screening measures, evidence of amyloid pathology, and a willing study partner to assist with assessments. The study will follow participants for up to about three years to assess changes in cognition, daily function, and other clinical outcomes. Key exclusion criteria include existing neurodegenerative diseases or unstable medical conditions. The trial is sponsored by Eli Lilly and conducted at major Chinese hospitals including Peking University Third Hospital, The First Hospital of Jilin University, and Xiangya Hospital Central South University.

Why it matters

Who can join: the full rules

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

Where it's running

• Peking University Third Hospital
  Beijing, China Recruiting
• The First Hospital of Jilin University
  Changchun, China Recruiting
• Xiangya Hospital Central South University
  Changsha, China Recruiting
• Sichuan Provincial People's Hospital
  Chengdu, China Recruiting
• 2nd Affiliated Hospital Chongqing Medical University
  Chongqing, China Recruiting
• The First Affiliated Hospital of Chongqing Medical University
  Chongqing, China Recruiting

Study contacts

• Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
• Email: LillyTrials@Lilly.com
• Phone: 1-317-615-4559

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.