A Real-World Comparative Study of Donanemab (LY3002813) Plus Usual Care Versus Usual Care Alone in US Participants With Early Symptomatic Alzheimer's Disease
Long-Term Real-World Comparative Effectiveness of Donanemab Plus Usual Care Versus Usual Care Alone in US Patients With Early Symptomatic Alzheimer's Disease (TRAILBLAZER-REAL US)
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 60 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Visits mentioned: 28 visits
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "The study will last about 273 weeks and may include up to 28 visits."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares donanemab plus usual care with usual care alone for people in the US with early Alzheimer's symptoms. It looks at how well the treatments work over time during routine care. The study lasts about 273 weeks and may include up to 28 visits.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Are getting care for suspected early Alzheimer's disease, with mild memory or thinking problems or mild dementia.
- Score at least 21 on the Telephone Interview for Cognitive Status, a phone test of memory and thinking.
- Have test results showing signs of amyloid beta, a protein linked to Alzheimer's disease. Results from within 12 months before joining may be used.
- Have a reliable study partner who is in frequent contact with you and can take phone calls every 6 months.
- Have electronic health records that can be linked to the study and agree to let the study team access them throughout the study.
Who can't join
- Have had a stroke from a blocked blood vessel or bleeding that leaves you needing help with walking, moving between positions, eating, bathing, dressing, or using the toilet.
- Have a current or recent serious or unstable illness other than Alzheimer's that the study doctor thinks could keep you or your study partner from completing the study.
- Are in, or plan to join, another clinical trial testing an experimental product.
- For the donanemab group only: have a medical reason you cannot safely receive donanemab, have an MRI scan, or receive the substance used in an amyloid PET scan.
Simplified for readability. The official criteria below are what the study team uses.
Official 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).
Study sites (1)
AL
- Rehabilitation & Neurological Services · Huntsville, AL 35805-4046Belinda Savage-Edwards · Principal investigatorMore trials in Huntsville