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NCT Number: NCT07571161

Donanemab (LY3002813) Trial in Chinese Participants With Cognitively Unimpaired (Preclinical) 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.

Recruiting

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Peking University Third Hospital, Beijing, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Donanemab

Drug

Administered IV

Other names: LY3002813

Placebo

Drug

Administered IV

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

Study contacts

Contact information is provided by the study sponsor or research team.

Physicians interested in becoming principal investigators please contact

CONTACT

[email protected]

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

[email protected]

1-317-615-4559

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2030
Study completion
2030
First posted
May 6, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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