RecruitingPhase 3

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

Lead sponsor

Eli Lilly and Company

Asset

Donanemab

Listed sites

Recruiting sites

Enrollment

140

estimated

Study population

Alzheimer’s disease

Key I/E criteria

•Amyloid biomarker required (plasma)•Tau biomarker required (plasma)•Study partner/caregiver required•MRI contraindications excluded•Brain MRI excludes superficial siderosis

Primary endpoint

•Clinical Progression

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Org study ID27822

Secondary IDI5T-MC-AACWEli Lilly and Company

NCT IDNCT07571161

Timeline

Milestones

Study start2026-04-30actual

Study first posted2026-05-06actual

Last update posted2026-07-07actual

Primary completion2030-04estimated (month precision)

Study completion2030-04estimated (month precision)

Assets

Drug assets

Donanemab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

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

Endpoints (5)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Tau biomarkers

Safety / tolerability / PK

Other (unclassified)

Global cognition

2 endpoints

Primary/protocol endpoint

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

Time frame:Baseline Up to Week 156

time to event, event

Secondary/protocol endpoint

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

Time frame:Baseline Up to Week 156

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Tau biomarkers

1 endpoint

Secondary/protocol endpoint

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

Time frame:Baseline, Week 52

Phosphorylated tau 217 (p-tau217)

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Pharmacokinetics (PK): Peak Concentrations of Serum Donanemab

Time frame:Baseline Up to Week 156

concentration, descriptive

Other (unclassified)

1 endpoint

Secondary/protocol endpoint/low confidence

PK: Trough Concentrations of Serum Donanemab

Time frame:Baseline Up to Week 156

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.