“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.

JournalDoc Comments:

  • 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?

Link to article in PubMed

Disclaimer:  Article of the Week selections by JournalDoc physicians are independent, unbiased and have no commercial conflict of interest. JournalDoc does not support or endorse the findings or opinions expressed in the article. Findings in the article may need to be supported by further research and/or the consensus of experts.