Donanemab Plus Usual Care for Early Alzheimer's Disease
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
Observational Study
Alzheimer Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
60 and older
Sex
Any
Study type
Observational
Participants needed
6,250 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for
This trial is looking for people with early Alzheimer's disease to see if the drug donanemab works better with usual care than just usual care alone. Participants will engage in regular visits and share their health data over about 273 weeks.
Are You a Good Fit for This Trial?
You may be able to join if
I have mild cognitive impairment or mild dementia due to Alzheimer's disease.
I have a TICS score of 21 or higher.
I have amyloid beta pathology supported by test results.
I have a reliable study partner who can be contacted regularly.
I am willing to share my electronic health records for the study.
You may not be able to join if
I have had a stroke that affects my ability to perform daily activities.
I have a serious or unstable illness that could interfere with the study.
I am enrolled in another clinical trial for a different drug.
I have contraindications to donanemab, MRI, or amyloid PET tracers.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 elec…
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.
Trial Locations
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Status
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 Cogniti…
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).
Contacts
There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
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