Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease
A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
2 other identifiers
interventional
140
1 country
30
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 alzheimer-disease
Started Apr 2026
Typical duration for phase_3 alzheimer-disease
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 30, 2026
CompletedFirst Posted
Study publicly available on registry
May 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2030
May 6, 2026
April 1, 2026
4 years
April 30, 2026
April 30, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
Baseline Up to Week 156
Secondary Outcomes (4)
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Baseline, Week 52
Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Baseline Up to Week 156
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab
Baseline Up to Week 156
PK: Trough Concentrations of Serum Donanemab
Baseline Up to Week 156
Study Arms (2)
Donanemab
EXPERIMENTALDonanemab administered intravenously (IV)
Placebo
PLACEBO COMPARATORPlacebo administered IV
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (30)
Peking University Third Hospital
Beijing, 100191, China
The First Hospital of Jilin University
Changchun, 100012, China
Xiangya Hospital Central South University
Changsha, 410008, China
Sichuan Provincial People's Hospital
Chengdu, 610072, China
2nd Affiliated Hospital Chongqing Medical University
Chongqing, 400010, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
Fujian Medical University Union Hospital
Fuzhou, 350001, China
Guangdong Provincial People's Hospital
Guangzhou, China
Anhui Provincial Hospital
Hefei, 230036, China
The Second Hospital of Jiaxing
Jiaxing, 314000, China
Jinan Central Hospital
Jinan, 250013, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006, China
Jiangsu Province Official Hospital
Nanjing, 210008, China
Nanjing Brain Hospital
Nanjing, 210029, China
Sir Run Run Hospital of Nanjing Medical University
Nanjing, 211166, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, 473061, China
Shanghai Sixth People's Hospital
Shanghai, 200030, China
Shanghai East Hospital
Shanghai, 200120, China
Huashan Hospital, Fudan University
Shanghai, 201107, China
Pudong New Area People's Hospital Shanghai
Shanghai, 201200, China
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, China
ShenZhen People's Hospital
Shenzhen, 518020, China
The First Hospital of Hebei Medical University
Shijiazhuang, 050031, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325027, China
Shaanxi provincial people's hospital
Xi'an, 710068, China
Xianyang Hospital of Yan'an University
Xianyang, 712000, China
Qinghai Provincial People's Hospital
Xining, 810007, China
Zigong First People's Hospital
Zigong, 643000, China
Zunyi First People's Hospital
Zunyi, 563002, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2026
First Posted
May 6, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2030
Study Completion (Estimated)
April 1, 2030
Last Updated
May 6, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication or approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.