Comparing Donanemab with Usual Care for Early 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)

This study is testing if adding donanemab to regular care can help people with early Alzheimer's disease feel better over time compared to just sticking with usual care.

Quick facts

• Study type: Observational
• Enrollment: 6250 (estimated)
• Ages: 60 Years and up
• Sex: All
• Sponsor: Eli Lilly and Company (Industry-sponsored)
• Drugs / interventions: donanemab
• Locations: 1 site (Huntsville, Alabama)
• Trial ID: NCT06566170 on ClinicalTrials.gov

What this trial studies

This study evaluates the long-term effectiveness of donanemab combined with usual care compared to usual care alone in individuals with early symptomatic Alzheimer's disease. It utilizes a prospective, observational cohort design to reflect real-world clinical practices, involving up to 28 visits over approximately 273 weeks. Participants will be monitored through assessments and linked to their electronic health records to gather comprehensive data on outcomes.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with mild cognitive impairment or mild dementia due to Alzheimer's disease, who have specific biomarker evidence of amyloid beta pathology.

Not a fit: Patients with prior strokes or those unable to perform daily activities independently may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of donanemab in improving outcomes for patients with early Alzheimer's disease.

How similar studies have performed: Other studies have shown promise in evaluating treatments for Alzheimer's disease, but the specific combination of donanemab with usual care is relatively novel.

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).

Where this trial is running

Huntsville, Alabama

• Rehabilitation & Neurological Services — Huntsville, Alabama, United States (Recruiting)

Study contacts

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

Conditions Alzheimer Disease