“The TRAILBLAZER-ALZ 2 Randomized Clinical Trial”
Journal of the American Medical Association (JAMA), July 17, 2023
Study Design and Number of Patients: RCT with 1736 participants in 277 medical centers in 8 countries; 18-month phase 3 trial
What’s Interesting about this article?
- Deposition of beta amyloid in the brain is an early event in Alzheimer disease, leading to neurofibrillary tangles and plaque composed of tau protein.
- Donanemab is a monoclonal antibody directed at amyloid and tau complexes.
- In this study, Donanemab significantly slowed clinical progression in those with early symptomatic Alzheimer disease at 76 weeks.
- As mentioned in an accompanying JAMA editorial, this drug may “usher in a new era in Alzheimer therapy”.
- Removal of amyloid plaques may lessen the worsening of the disease, but is not a “cure”; so the modest clinical benefits must be balanced against adverse effects and the cost of the drug. Are amyloid and tau the cause of the disease, or just the result of damage to neurons?
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