RecruitingNCT06566170

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)


Sponsor

Eli Lilly and Company

Enrollment

6,250 participants

Start Date

Oct 7, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This observational study is following patients treated with donanemab (a drug that removes amyloid plaques from the brain) for Alzheimer's disease in the real world — outside of a clinical trial — to compare outcomes with those who receive standard care, using electronic health records. **You may be eligible if...** - You have mild cognitive impairment (early memory problems) or mild-stage Alzheimer's disease - You have confirmed amyloid plaque buildup in your brain (shown by blood tests, PET scan, or spinal fluid analysis) - You scored at least 21 on the Telephone Interview for Cognitive Status (TICS) - You have a reliable study partner (family member or caregiver) who can be contacted every 6 months - Your electronic health records are available for research linkage **You may NOT be eligible if...** - You have had a prior stroke that significantly affects your daily functioning - You have another serious illness likely to affect your life expectancy or ability to complete the study - You require long-term institutional-level care - You do not have a study partner available Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDonanemab

Administered IV

DRUGUsual Care

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


Locations(1)

Rehabilitation & Neurological Services

Huntsville, Alabama, United States

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NCT06566170


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