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

Sponsor
Eli Lilly and Company
Study ID
NCT07571161
Phase
PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
55 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Donanemab — DRUG
    Administered IV
  • Placebo — DRUG
    Administered IV

Study Details

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.

Key Dates

First listed
May 6, 2026
Start date
Apr 30, 2026
Status verified
Aug 2026
Primary completion
Apr 30, 2030
Completion
Apr 30, 2030

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Donanemab
    Donanemab administered intravenously (IV)
  • Placebo Comparator: Placebo
    Placebo administered IV

Primary Outcome Measure

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

Central Contacts

  • Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
    1-317-615-4559
    [email protected]
  • Physicians interested in becoming principal investigators please contact
    [email protected]

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