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

NCT06566170 | Recruiting FDA Drug

• 2 other identifiers: 18721I5T-MC-AACS
• Study Type: observational
• Target: 6,250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])

  The DS is a caregiver-reported outcome assessing the need for daily in-home or institutional assistance by participants with AD. The DS is completed as a structured interview with a knowledgeable caregiver or study partner. The scale is composed of 13 items evaluating progressive needs for assistance. The total score ranges from 0 to 15, with higher scores indicating a greater degree of dependence on external support.

  Up to 5 Years

Secondary Outcomes (9)

• Time to Loss of Independence (Dependence Level ≥3 as derived from the DS) for the Subgroup of Participants with Dependence Level <3 at Baseline

  Up to 5 Years

• Time to Institutionalization from Baseline for the Subgroup of Participants not Institutionalized at Baseline

  Up to 5 Years

• Change from Baseline Over Time (Semi-Annually) in DS Total Score

  Baseline, Up to 5 Years

• Change from Baseline Over Time (Assessed Semi-Annually) in Functional Assessment Questionnaire (FAQ) Total Score

  Baseline, Up to 5 Years

• Change from Baseline Over Time (Assessed Yearly) in Neuropsychiatric Inventory (NPI-Q) Total Severity Score

  Baseline, Up to 5 Years

Study Arms (2)

Donanemab Group + Usual Care

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

Drug: Donanemab; Drug: Usual Care

Usual Care Group

Participants will receive usual care.

Drug: Usual Care

Interventions

Donanemab DRUG

Administered IV

Also known as: LY3002813

Donanemab Group + Usual Care

Usual Care DRUG

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

Donanemab Group + Usual Care; Usual Care Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of a donanemab plus usual care group and a usual care alone group. Participants will be enrolled 1:2 into donanemab plus usual care and usual care alone groups to allow enough participants in the usual care group to be matched with participants in the donanemab group to enable robust comparative effectiveness analyses.

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Rehabilitation & Neurological Services

Huntsville, Alabama, 35805-4046, United States

RECRUITING

MeSH Terms

Conditions

Alzheimer Disease

Interventions

donanemab

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Central Study Contacts

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

CONTACT

1-317-615-4559; clinical_inquiry_hub@lilly.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2024
• First Posted: August 22, 2024
• Study Start: October 7, 2024
• Primary Completion (Estimated): February 1, 2033
• Study Completion (Estimated): February 1, 2033
• Last Updated: October 9, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

Locations

US (1)