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RecruitingNCT07571161Updated Aug 24, 2026

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

A Phase 3 interventional study of Donanemab and Placebo in Alzheimer Disease, sponsored by Eli Lilly and Company. Recruiting at 30 sites in China. Open to participants aged 55 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-24.

Sponsored by Eli Lilly and Company · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2026; still recruiting 5 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
55 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Alzheimer Disease

Browse trials for

03

In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 140 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Eli Lilly and Company is the lead sponsor of 2,048 studies on the registry; 140 are open to participants now.

Of its 521 completed or terminated interventional studies of FDA-regulated products, 341 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
140 participants (estimated)

Study arms

  • Experimental
    Donanemab

    Donanemab administered intravenously (IV)

    Drug: Donanemab

  • Placebo comparator
    Placebo

    Placebo administered IV

    Drug: Placebo

Interventions

  • DrugDonanemab

    Administered IV

    Also known as: LY3002813

  • DrugPlacebo

    Administered IV

06

What researchers measure

Primary outcomes

  1. Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)

    Time frame: Baseline Up to Week 156

Secondary outcomes

  1. Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)

    Time frame: Baseline, Week 52

  2. Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB)

    Time frame: Baseline Up to Week 156

  3. Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab

    Time frame: Baseline Up to Week 156

  4. PK: Trough Concentrations of Serum Donanemab

    Time frame: Baseline Up to Week 156

07

Study locations

30 of 30 sites recruiting
  • Peking University Third Hospital
    Beijing, 100191, China
    • Qiong Yang · Principal investigator
    Recruiting
  • The First Hospital of Jilin University
    Changchun, 100012, China
    • · Contact · 13504313689
    • Li Sun · Principal investigator
    Recruiting
  • Xiangya Hospital Central South University
    Changsha, 410008, China
    • · Contact · 073189753041
    • Lu Shen · Principal investigator
    Recruiting
  • Sichuan Provincial People's Hospital
    Chengdu, 610072, China
    • Nengwei Yu · Principal investigator
    Recruiting
  • 2nd Affiliated Hospital Chongqing Medical University
    Chongqing, 400010, China
    • · Contact · +86 13032327639
    • Xiaofeng Li · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Chongqing Medical University
    Chongqing, 400016, China
    • · Contact · +86 13618236535
    • Yang Lv · Principal investigator
    Recruiting
  • Fujian Medical University Union Hospital
    Fuzhou, 350001, China
    • · Contact · 18149568903
    • Jiawei Xin · Principal investigator
    Recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, China
    • jiehao zhao · Principal investigator
    Recruiting
  • Anhui Provincial Hospital
    Hefei, 230036, China
    • Zhaozhao Cheng · Principal investigator
    Recruiting
  • The Second Hospital of Jiaxing
    Jiaxing, 314000, China
    • Yanping Wang · Principal investigator
    Recruiting
  • Jinan Central Hospital
    Jinan, 250100, China
    • · Contact · 15318816109
    • Hong Bian · Principal investigator
    Recruiting
  • The Second Affiliated Hospital of Nanchang University
    Nanchang, 330038, China
    • Zhenyu Tang · Principal investigator
    Recruiting
  • Jiangsu Province Official Hospital
    Nanjing, 210008, China
    • Kezhong Zhang · Principal investigator
    Recruiting
  • Nanjing Brain Hospital
    Nanjing, 210029, China
    • · Contact · 13372003816
    • Weiwei Jiang · Principal investigator
    Recruiting
  • Sir Run Run Hospital of Nanjing Medical University
    Nanjing, 211166, China
    • Xiang Lu · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Nanyang Medical College
    Nanyang, 473061, China
    • Qian Deng · Principal investigator
    Recruiting
  • Shanghai Sixth People's Hospital
    Shanghai, 200030, China
    • · Contact · 02124056429
    • Qihao Guo · Principal investigator
    Recruiting
  • Shanghai East Hospital
    Shanghai, 200120, China
    • You Yin · Principal investigator
    Recruiting
  • Renji Hospital Shanghai Jiao Tong University School of Medicine
    Shanghai, 200127, China
    • Gang Wang · Principal investigator
    Recruiting
  • Huashan Hospital, Fudan University
    Shanghai, 201107, China
    • · Contact · 021-111111
    • Jintai Yu · Principal investigator
    Recruiting
  • Pudong New Area People's Hospital Shanghai
    Shanghai, 201200, China
    • · Contact · 021-20509000
    • Xiaohui Zhao · Principal investigator
    Recruiting
  • ShenZhen People's Hospital
    Shenzhen, 518020, China
    • · Contact · +86 13662205122
    • Liangyu Zou · Principal investigator
    Recruiting
  • The First Hospital of Hebei Medical University
    Shijiazhuang, 050031, China
    • · Contact · 0311-87155010
    • Xiaowei Ma · Principal investigator
    Recruiting
  • Tianjin Medical University General Hospital
    Tianjin, 300052, China
    • · Contact · 022-6036225
    • Li Yang · Principal investigator
    Recruiting
  • The First Affiliated Hospital of Wenzhou Medical University
    Wenzhou, 325027, China
    • Zhen Wang · Principal investigator
    Recruiting
  • Shaanxi provincial people's hospital
    Xi'an, 710068, China
    • Rui Li · Principal investigator
    Recruiting
  • Xianyang Hospital of Yan'an University
    Xianyang, 712000, China
    • · Contact · 13572769709
    • Aihong Guo · Principal investigator
    Recruiting
  • Qinghai Provincial People's Hospital
    Xining, 810007, China
    • Xin Zhong · Principal investigator
    Recruiting
  • Zigong First People's Hospital
    Zigong, 643000, China
    • · Contact · 15983171312
    • Xiaoya Xu · Principal investigator
    Recruiting
  • Zunyi First People's Hospital
    Zunyi, 563002, China
    • Fei Feng · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — 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.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07571161
Lead sponsor
Eli Lilly and Company
Responsible party
Sponsor
First posted
May 6, 2026
Start date
Apr 30, 2026
Primary completion
Apr 2030 (estimated)
Completion
Apr 2030 (estimated)
Last update
Aug 24, 2026

Study contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
Contact
LillyTrials@Lilly.com
1-317-615-4559
Physicians interested in becoming principal investigators please contact
Contact
clinical_inquiry_hub@lilly.com
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)
study director · Eli Lilly and Company

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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