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Similar Publications
Adverse Events as a Cause of Unblinding of Allocated Arms in Anti-Amyloid Therapy Trials: A Meta-Analysis of the Predictive Value.
J Alzheimers Dis
October 2024
Department of Neuropathology, Graduate School of Medicine, The University of Tokyo, Tokyo, Japan.
Article Synopsis
- Anti-amyloid drugs like lecanemab used for early Alzheimer's disease can cause adverse events (AEs), including specific brain imaging abnormalities and infusion reactions.
- A meta-analysis was conducted to assess the predictive value of these adverse events, revealing that ARIA-E has a high positive predictive value (PPV) of 0.915, while ARIA hemorrhage has a low PPV of 0.630.
- The findings indicate that the impact of AEs, especially ARIA-E, can influence the results of clinical trials and emphasize the need to reduce potential biases stemming from these events.
The Black Book of Psychotropic Dosing and Monitoring.
Psychopharmacol Bull
July 2024
Dr. Schatzberg is Kenneth T. Norris, Jr. professor in the Department of Psychiatry and Behavioral Sciences at the Stanford University School of Medicine in California.
Article Synopsis
- Several innovative treatments for mental health and neurodegenerative conditions have emerged or are set to be approved, including new antidepressants and drugs targeting PTSD and Alzheimer's disease.
- The new antidepressant Auvelity combines bupropion and dextromethorphan, enhancing efficacy and tolerability compared to bupropion alone, though its comparison to higher doses of bupropion is still uncertain.
- Zuranolone, a recent addition for treating postpartum depression, is more convenient than its predecessor brexanolone due to its oral formulation instead of requiring an intravenous infusion.
Recalibrating the Risk-Benefit Profiles of Lecanemab and Donanemab: Scales, Immunoreactivity, and Changes in Amyloid-β42.
J Alzheimers Dis
May 2024
Science Norms Democracy, UMR 8011 Sorbonne University, Paris, France.
Article Synopsis
- Recent trials of anti-amyloid-β antibodies for Alzheimer's disease showed similar effect sizes but raised concerns due to high rates of adverse events and reliance on non-reactive saline as a placebo.
- Unlike previous antibody trials that were less reactive and ineffective, these new trials suggest potential bias in results, potentially overstating their benefits.
- The data indicates that while these antibodies reduce amyloid, they also increase a specific form of amyloid-β in cerebrospinal fluid, suggesting a need to rethink their effectiveness and explore alternative treatment strategies.
Potential impact of unblinding on observed treatment effects in Alzheimer's disease trials.
Alzheimers Dement
April 2024
Department of Epidemiology, Erasmus MC - University Medical Centre Rotterdam, Rotterdam, the Netherlands.
Article Synopsis
- Monoclonal antibodies targeting amyloid beta often cause adverse effects, which can lead to unblinding in randomized controlled trials (RCTs) for Alzheimer's disease, affecting the validity of results.
- In phase 3 trials, drugs like lecanemab, aducanumab, and donanemab showed high rates of amyloid-related issues (22%-44%), suggesting that these side effects likely caused unblinding among participants.
- The study found that the cognitive improvements seen in trials might be largely influenced by psychological effects from unblinding, with significant differences in the required cognitive rating changes needed to account for observed drug benefits.
Substantial Doubt Remains about the Efficacy of Anti-Amyloid Antibodies.
J Alzheimers Dis
January 2024
Department of Neurology and Neurological Sciences, Stanford University, Stanford, CA, USA.
Article Synopsis
- The FDA's approval of aducanumab and lecanemab, along with promising phase 3 trial results for donanemab, has generated excitement for anti-amyloid antibodies in treating Alzheimer's.
- However, there are significant concerns about these trials, including the lack of clear evidence linking amyloid reduction to actual clinical improvement.
- Other issues involve potential biases in trial reports and donanemab not affecting tau burden, raising doubts about the overall effectiveness of anti-amyloid treatments.
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