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Observational Study of Donanemab for Early Alzheimer's Disease

This study is looking at how well donanemab (a drug given through an IV) works over a long time when added to usual care, compared to usual care alone, for people with early symptoms of Alzheimer's disease. Usual care includes medications (but not other amyloid-targeting drugs) or non-drug treatments. You might be able to join if you are 60 or older, have mild cognitive impairment (MCI) or mild dementia due to Alzheimer's, and have evidence of amyloid beta (Aβ) pathology (a specific protein buildup in the brain). The main goal is to see if donanemab affects how long it takes for someone's need for help with daily activities to increase. The study's current status is unclear, but it plans to include 6250 participants.

Study design
This is an observational study, meaning researchers will watch and collect information about participants in a real-world setting. It will include up to 6250 participants.
What's involved
The study will last about 273 weeks (around 5 years) and may include up to 28 visits.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 5 years to see the time to first increase in their dependence level.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06566170

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

Recruiting
Not specifiedAges 60+Observational
Eli Lilly and Company
~6,250 participants
Updated 2025-10-09 on ClinicalTrials.gov
What's tested:DonanemabUsual Care

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])
Measured over Up to 5 Years

Conditions

Alzheimer Disease

Explore related trials

Alzheimer's DiseaseAmyloid beta peptide

Where it's being run

1 sites across 1 states
Alabama1

Study leadership

  • 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) · STUDY_DIRECTOR · Eli Lilly and Company

Who to contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
[email protected]
1-317-615-4559
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Time to First Increase in Dependence Level Above Baseline (as derived from the Dependence Scale [DS])Up to 5 Years

    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.