A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease

NCT ID: NCT06566170

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 6250 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-10-07
• Study Completion Date: 2033-02-28

Brief Summary

The main purpose of this study is to evaluate the long-term effectiveness of donanemab plus usual care versus usual care alone in participants with early symptomatic AD. The study will employ a prospective, observational cohort design with participant management resembling real-world practice to the greatest extent possible via prospective assessments and linkage to historical and prospective electronic health records. The study will last about 273 weeks and may include up to 28 visits.

Conditions

Alzheimer Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Donanemab Group + Usual Care

Participants will receive open-label (unblinded) donanemab intravenously (IV) and Usual Care

Donanemab

Intervention Type: DRUG

Administered IV

Usual Care

Intervention Type: DRUG

Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Usual Care Group

Participants will receive usual care.

Usual Care

Intervention Type: DRUG

Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Interventions

Donanemab

Administered IV

Intervention Type: DRUG

Usual Care

Medication (excluding amyloid-targeting agents) or non-pharmacological therapy including watchful waiting.

Intervention Type: DRUG

Other Intervention Names

LY3002813

Eligibility Criteria

Inclusion Criteria

Participants

• are under care for presumed mild cognitive impairment (MCI) or mild dementia stage of AD (Note: neither a biomarker-based diagnosis of AD nor a diagnosis in electronic health records [EHR] is required prior to screening)
• have a Telephone Interview for Cognitive Status (TICS) score of ≥21
• presence of amyloid beta (Aβ) pathology supported by biomarker results (e.g., P-tau, amyloid positron emission tomography (PET), and/or cerebrospinal fluid [CSF]). (Note: A historical biomarker may be used for eligibility if performed within 12 months of study entry)
• have a reliable study partner who is in frequent contact with the participant and will be available by telephone at designated times (every 6 months), and
• have EHR data available for linkage and are willing to allow access to EHR data for the duration of the study.

Exclusion Criteria

• have prior ischemic or hemorrhagic stroke(s) with an inability to independently perform any one or more basic activities of daily living (ADLs) (i.e., walking, transferring, eating, bathing, dressing, or toileting). (Note: mixed dementias with amyloid pathology are permitted)
• have current or recent serious or unstable illness (other than AD) that, in the investigator's opinion, could interfere with the ability of the participant or study partner to complete the study (e.g., life expectancy of less than 36 months, requirement for long-term (>12 months) institutional-level care, serious psychiatric illness, etc.)
• are currently enrolled or intend to enroll in a clinical trial of another investigational product, and
• have contraindications to donanemab, magnetic resonance imaging (MRI), or amyloid PET tracers. (Donanemab group only).

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Rehabilitation & Neurological Services

Huntsville, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Role: CONTACT

clinical_inquiry_hub@lilly.com

1-317-615-4559

Other Identifiers

I5T-MC-AACS

Identifier Type: OTHER

Identifier Source: secondary_id

18721

Identifier Type: -

Identifier Source: org_study_id