Dr Kenton Zavitz, Director of Clinical Affairs at Cambridge Cognition, and Dr Robert Smith, Consultant Neuropsychologist, hosted a webinar to discuss clinical trials for early Alzheimer’s disease.
Join them to hear more about overcoming the barriers to expedite the drug development process.
Despite considerable efforts by biopharmaceutical companies, late-stage trial failures have plagued the drug development process for targeting Alzheimer’s disease. So what’s the problem?
Typically, patients with a definitive Alzheimer’s disease diagnosis have been recruited into clinical studies of new potential therapies. However, this tasks the treatment with the considerable challenge of both halting and/or reversing the existing pathology. Consequently, treatment trials are now moving earlier in the disease process towards preventative rather than reactive administration.
To guide clinical trials in early stage Alzheimer’s disease, the US FDA have defined these early stages, and suggested possible primary endpoints that could serve as the basis for drug approval. The approaches to trial design suggested in the guidance provide exciting new opportunities for drug development but also raise unique challenges to the execution of such trials. One major challenge is finding the right patients for early stage Alzheimer’s disease clinical trials.
In this webinar, Dr. Kenton Zavitz, Director of Clinical Affairs at Cambridge Cognition, and Dr Robert Smith, Consultant Neuropsychologist, discussed the issues surrounding the identification of patients for these early Alzheimer’s disease trials, and suggested potential solutions and strategies to facilitate both clinical development as well as drug commercialization.
Key discussion points:
- How to understand the regulatory perspective on developing treatments for early Alzheimer’s disease
- How to identify patients with early Alzheimer’s disease
- How to conduct clinical trials in early Alzheimer’s disease: Lessons learned from operationalising recruitment
- Finding the right patients for phase IV: bringing a drug to market
- Next steps for Alzheimer’s disease clinical trials