Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease
Recruiting · NCT07571161 · Interventional (participants receive a specific treatment) · Lead sponsor: Eli Lilly and Company
View the official record on ClinicalTrials.gov →Interventions studied
DonanemabPlacebo
What this trial is about
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.
Who can take part
Age range
55 Years to 80 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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 is running
30 locations listed.
- Peking University Third Hospital - Beijing, China
- The First Hospital of Jilin University - Changchun, China
- Xiangya Hospital Central South University - Changsha, China
- Sichuan Provincial People's Hospital - Chengdu, China
- 2nd Affiliated Hospital Chongqing Medical University - Chongqing, China
- The First Affiliated Hospital of Chongqing Medical University - Chongqing, China
- Fujian Medical University Union Hospital - Fuzhou, China
- Guangdong Provincial People's Hospital - Guangzhou, China
- Anhui Provincial Hospital - Hefei, China
- The Second Hospital of Jiaxing - Jiaxing, China
- Jinan Central Hospital - Jinan, China
- The Second Affiliated Hospital of Nanchang University - Nanchang, China
- Jiangsu Province Official Hospital - Nanjing, China
- Nanjing Brain Hospital - Nanjing, China
- Sir Run Run Hospital of Nanjing Medical University - Nanjing, China
- The First Affiliated Hospital of Nanyang Medical College - Nanyang, China
- Shanghai Sixth People's Hospital - Shanghai, China
- Shanghai East Hospital - Shanghai, China
- Renji Hospital Shanghai Jiao Tong University School of Medicine - Shanghai, China
- Huashan Hospital, Fudan University - Shanghai, China
- Pudong New Area People's Hospital Shanghai - Shanghai, China
- ShenZhen People's Hospital - Shenzhen, China
- The First Hospital of Hebei Medical University - Shijiazhuang, China
- Tianjin Medical University General Hospital - Tianjin, China
- The First Affiliated Hospital of Wenzhou Medical University - Wenzhou, China
- Shaanxi provincial people's hospital - Xi'an, China
- Xianyang Hospital of Yan'an University - Xianyang, China
- Qinghai Provincial People's Hospital - Xining, China
- Zigong First People's Hospital - Zigong, China
- Zunyi First People's Hospital - Zunyi, China