Alzheimer DiseasePhase 3NCT07571161
Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) Alzheimer's Disease
A Phase 3 study testing Donanemab in people with Alzheimer Disease, run by Eli Lilly and Company at 30 sites in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Donanemab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 30 sitesChina
- Study dates
- 30 Apr 2026to Apr 2030
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
30 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
30 sites in 1 country
China30 sites, 30 recruiting
- Recruiting
Peking University Third Hospital
Beijing, 100191
Qiong Yang
- Recruiting
The First Hospital of Jilin University
Changchun, 100012
13504313689
Li Sun
- Recruiting
Xiangya Hospital Central South University
Changsha, 410008
073189753041
Lu Shen
- Recruiting
Sichuan Provincial People's Hospital
Chengdu, 610072
Nengwei Yu
- Recruiting
2nd Affiliated Hospital Chongqing Medical University
Chongqing, 400010
+86 13032327639
Xiaofeng Li
- Recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016
+86 13618236535
Yang Lv
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
18149568903
Jiawei Xin
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
jiehao zhao
- Recruiting
Anhui Provincial Hospital
Hefei, 230036
Zhaozhao Cheng
- Recruiting
The Second Hospital of Jiaxing
Jiaxing, 314000
Yanping Wang
- Recruiting
Jinan Central Hospital
Jinan, 250100
15318816109
Hong Bian
- Recruiting
The Second Affiliated Hospital of Nanchang University
Nanchang, 330038
Zhenyu Tang
- Recruiting
Jiangsu Province Official Hospital
Nanjing, 210008
Kezhong Zhang
- Recruiting
Nanjing Brain Hospital
Nanjing, 210029
13372003816
Weiwei Jiang
- Recruiting
Sir Run Run Hospital of Nanjing Medical University
Nanjing, 211166
Xiang Lu
- Recruiting
The First Affiliated Hospital of Nanyang Medical College
Nanyang, 473061
Qian Deng
- Recruiting
Shanghai Sixth People's Hospital
Shanghai, 200030
02124056429
Qihao Guo
- Recruiting
Shanghai East Hospital
Shanghai, 200120
You Yin
- Recruiting
Renji Hospital Shanghai Jiao Tong University School of Medicine
Shanghai, 200127
Gang Wang
- Recruiting
Huashan Hospital, Fudan University
Shanghai, 201107
021-111111
Jintai Yu
- Recruiting
Pudong New Area People's Hospital Shanghai
Shanghai, 201200
021-20509000
Xiaohui Zhao
- Recruiting
ShenZhen People's Hospital
Shenzhen, 518020
+86 13662205122
Liangyu Zou
- Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, 050031
0311-87155010
Xiaowei Ma
- Recruiting
Tianjin Medical University General Hospital
Tianjin, 300052
022-6036225
Li Yang
- Recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325027
Zhen Wang
- Recruiting
Shaanxi provincial people's hospital
Xi'an, 710068
Rui Li
- Recruiting
Xianyang Hospital of Yan'an University
Xianyang, 712000
13572769709
Aihong Guo
- Recruiting
Qinghai Provincial People's Hospital
Xining, 810007
Xin Zhong
- Recruiting
Zigong First People's Hospital
Zigong, 643000
15983171312
Xiaoya Xu
- Recruiting
Zunyi First People's Hospital
Zunyi, 563002
Fei Feng
About this study
Official title: 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.
- Conditions
- Alzheimer Disease
- Being tested
- Donanemab, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DonanemabDrug
Also called LY3002813
Administered IV
PlaceboDrug
Administered IV
| Study group | Role | What they receive |
|---|---|---|
| Donanemab | Experimental | Donanemab administered intravenously (IV) Receives: Drug: Donanemab |
| Placebo | Placebo comparator | Placebo administered IV Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
Measured: Baseline Up to Week 156
Secondary outcomes (4)
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Measured: Baseline, Week 52
Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Measured: Baseline Up to Week 156
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab
Measured: Baseline Up to Week 156
PK: Trough Concentrations of Serum Donanemab
Measured: Baseline Up to Week 156
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2026
- Study start30 Apr 2026
- Primary completionApr 2030 (estimated)
- Study completionApr 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07571161
- Sponsor's protocol ID
- 27822
- Other IDs
- I5T-MC-AACW
- Status last verified
- Aug 2026
- First submitted
- 30 Apr 2026
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Donanemab Versus Placebo in Chinese Participants at Risk for Cognitive and Functional Decline of Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07571161
- Acronym / sponsor ID
- 27822
- Conditions
- Alzheimer Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Apr 2030 (estimated)
- Study completion
- Apr 2030 (estimated)
- First posted
- 6 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Donanemab | Experimental | Drug: DonanemabDonanemab administered intravenously (IV) |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo administered IV |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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:
- Have adequate literacy, vision, and hearing for neuropsychological testing
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DonanemabAlso: LY3002813Administered IV | Drug | Donanemab |
| PlaceboAdministered IV | Drug | Placebo |
Primary outcome
Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS)
Time frame: Baseline Up to Week 156
4 secondary outcomes
Change From Baseline in Plasma Phosphorylated Tau at Threonine 217 (P-tau217)
Time frame: Baseline, Week 52
Change From Baseline as Measured by Clinical Dementia Rating-Sum of Boxes (CDR-SB)
Time frame: Baseline Up to Week 156
Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab
Time frame: Baseline Up to Week 156
PK: Trough Concentrations of Serum Donanemab
Time frame: Baseline Up to Week 156
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
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
30 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Donanemab in people with Alzheimer Disease, run by Eli Lilly and Company at 30 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or (1-317-615-4559, LillyTrials@Lilly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Clinical Progression as Measured by Clinical Dementia Rating-Global Score (CDR-GS) (time frame: Baseline Up to Week 156). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026.