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

August 21, 2026 updated by: Eli Lilly and Company

A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

140

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

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

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100191
        • Recruiting
        • Peking University Third Hospital
        • Principal Investigator:
          • Qiong Yang
      • Changchun, China, 100012
        • Recruiting
        • The First Hospital of Jilin University
        • Contact:
          • Phone Number: 13504313689
        • Principal Investigator:
          • li Sun
      • Changsha, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Contact:
          • Phone Number: 073189753041
        • Principal Investigator:
          • Lu Shen
      • Chengdu, China, 610072
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Principal Investigator:
          • Nengwei Yu
      • Chongqing, China, 400016
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
          • Phone Number: +86 13618236535
        • Principal Investigator:
          • Yang Lv
      • Chongqing, China, 400010
        • Recruiting
        • 2nd Affiliated Hospital Chongqing Medical University
        • Principal Investigator:
          • Xiaofeng Li
        • Contact:
          • Phone Number: +86 13032327639
      • Fuzhou, China, 350001
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:
          • Phone Number: 18149568903
        • Principal Investigator:
          • Jiawei Xin
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Principal Investigator:
          • jiehao zhao
      • Hefei, China, 230036
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Zhaozhao Cheng
      • Jiaxing, China, 314000
        • Recruiting
        • The Second Hospital of Jiaxing
        • Principal Investigator:
          • Yanping Wang
      • Jinan, China, 250100
        • Recruiting
        • Jinan Central Hospital
        • Principal Investigator:
          • Hong Bian
        • Contact:
          • Phone Number: 15318816109
      • Nanchang, China, 330038
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Zhenyu Tang
      • Nanjing, China, 210029
        • Recruiting
        • Nanjing Brain Hospital
        • Contact:
          • Phone Number: 13372003816
        • Principal Investigator:
          • Weiwei Jiang
      • Nanjing, China, 211166
        • Recruiting
        • SIR RUN RUN hospital of Nanjing Medical University
        • Principal Investigator:
          • Xiang Lu
      • Nanjing, China, 210008
        • Recruiting
        • Jiangsu Province Official Hospital
        • Principal Investigator:
          • Kezhong Zhang
      • Nanyang, China, 473061
        • Recruiting
        • The First Affiliated Hospital of Nanyang Medical College
        • Principal Investigator:
          • Qian Deng
      • Shanghai, China, 200120
        • Recruiting
        • Shanghai East Hospital
        • Principal Investigator:
          • You Yin
      • Shanghai, China, 200030
        • Recruiting
        • Shanghai Sixth People's Hospital
        • Contact:
          • Phone Number: 02124056429
        • Principal Investigator:
          • Qihao Guo
      • Shanghai, China, 201200
        • Recruiting
        • Pudong New Area People's Hospital Shanghai
        • Contact:
          • Phone Number: 021-20509000
        • Principal Investigator:
          • Xiaohui Zhao
      • Shanghai, China, 201107
        • Recruiting
        • Huashan Hospital, Fudan University
        • Principal Investigator:
          • Jintai Yu
        • Contact:
          • Phone Number: 021-111111
      • Shanghai, China, 200127
        • Recruiting
        • Renji Hospital Shanghai Jiao Tong University School of Medicine
        • Principal Investigator:
          • Gang Wang
      • Shenzhen, China, 518020
        • Recruiting
        • Shenzhen People's Hospital
        • Contact:
          • Phone Number: +86 13662205122
        • Principal Investigator:
          • Liangyu Zou
      • Shijiazhuang, China, 050031
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
          • Phone Number: 0311-87155010
        • Principal Investigator:
          • Xiaowei Ma
      • Tianjin, China, 300052
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:
          • Phone Number: 022-6036225
        • Principal Investigator:
          • Li Yang
      • Wenzhou, China, 325027
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Principal Investigator:
          • Zhen Wang
      • Xi'an, China, 710068
        • Recruiting
        • Shaanxi Provincial People's Hospital
        • Principal Investigator:
          • Rui Li
      • Xianyang, China, 712000
        • Recruiting
        • Xianyang Hospital of Yan'an University
        • Contact:
          • Phone Number: 13572769709
        • Principal Investigator:
          • Aihong Guo
      • Xining, China, 810007
        • Recruiting
        • Qinghai Provincial People's Hospital
        • Principal Investigator:
          • Xin Zhong
      • Zigong, China, 643000
        • Recruiting
        • Zigong First People's Hospital
        • Contact:
          • Phone Number: 15983171312
        • Principal Investigator:
          • Xiaoya Xu
      • Zunyi, China, 563002
        • Recruiting
        • Zunyi First People's Hospital
        • Principal Investigator:
          • Fei Feng

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Placebo administered IV
Drug: Placebo
Administered IV
Experimental: Donanemab
Donanemab administered intravenously (IV)
Drug: Donanemab
Administered IV
Other Names:
  • LY3002813

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
Time Frame: Baseline Up to Week 156
Baseline Up to Week 156

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Time Frame: Baseline, Week 52
Baseline, Week 52
Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time Frame: Baseline Up to Week 156
Baseline Up to Week 156
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab
Time Frame: Baseline Up to Week 156
Baseline Up to Week 156
PK: Trough Concentrations of Serum Donanemab
Time Frame: Baseline Up to Week 156
Baseline Up to Week 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Investigators

  • 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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2026

Primary Completion (Estimated)

April 1, 2030

Study Completion (Estimated)

April 1, 2030

Study Registration Dates

First Submitted

April 30, 2026

First Submitted That Met QC Criteria

April 30, 2026

First Posted (Actual)

May 6, 2026

Study Record Updates

Last Update Posted (Actual)

August 24, 2026

Last Update Submitted That Met QC Criteria

August 21, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 27822 (Abramson Cancer Center)
  • I5T-MC-AACW (Other Identifier: Eli Lilly and Company)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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