Safety Concerns in Neurological Clinical Trials: A Challenge That the FDA Must Resolve DOI Creative Commons
Sarfaraz K. Niazi

Biomedicines, Journal Year: 2024, Volume and Issue: 12(12), P. 2918 - 2918

Published: Dec. 22, 2024

Background: Monoclonal antibodies approved by the FDA, lecanemab, donanemab, and aducanumab, are failing to meet expected efficacy treat early Alzheimer’s disease, aducanumab has been recalled. Methods: Recently, it was reported that clinical trials of these may have violated patient’s rights subjected them high, likely lethal risk. The challenge with developing neurological disorders is their poor blood–brain barrier (BBB) penetration if antibody must enter brain, resulting in almost negligible brain bioavailability, requiring high dosing can be toxic. Results: drugs should also reviewed, considering placebo effects, since all shown severe side effects not prevented responses. In this critical urgent advice I am suggesting a guideline amendment proof sufficient bioavailability at site action, where known. Conclusions: For cross barrier, there proven options such as conjugating transferrin protein, making its absence more questionable.

Language: Английский

Safety Concerns in Neurological Clinical Trials: A Challenge That the FDA Must Resolve DOI Creative Commons
Sarfaraz K. Niazi

Biomedicines, Journal Year: 2024, Volume and Issue: 12(12), P. 2918 - 2918

Published: Dec. 22, 2024

Background: Monoclonal antibodies approved by the FDA, lecanemab, donanemab, and aducanumab, are failing to meet expected efficacy treat early Alzheimer’s disease, aducanumab has been recalled. Methods: Recently, it was reported that clinical trials of these may have violated patient’s rights subjected them high, likely lethal risk. The challenge with developing neurological disorders is their poor blood–brain barrier (BBB) penetration if antibody must enter brain, resulting in almost negligible brain bioavailability, requiring high dosing can be toxic. Results: drugs should also reviewed, considering placebo effects, since all shown severe side effects not prevented responses. In this critical urgent advice I am suggesting a guideline amendment proof sufficient bioavailability at site action, where known. Conclusions: For cross barrier, there proven options such as conjugating transferrin protein, making its absence more questionable.

Language: Английский

Citations

2