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May 17, 2006
Perry Cohen, Director, Parkinson Pipeline Project

What will FDA approval of Exelon mean for the PD community?


The FDA advisory panel's approval of the first treatment (Exelon) for PD dementia (PDD) or Lewey body dementia, endorses the concept that PDD is a distinct disease entity, with distinguishable criteria from Alzheimer's Disease (AD) dementia, "warranting separate consideration by researchers and clinicians," said Perry Cohen, Director of the Parkinson Pipeline Project.

"(This) will shine a light on a subject long neglected by PD research: cognitive and emotional effects of PD," he told the FDA advisory committee during the pubic comment period. "It should also raise physician and patient awareness of the often overlooked but numerous and problematic effects of PD beyond the cardinal motor symptoms."

Advertisements for Exelon could raise awareness of mental health issues associated with PD, and help doctors diagnose and treat these problems. Cohen challenged the drug's sponsor, Novartis, to take a lead in a public/private effort to track and monitor the longer term safety and efficacy of adding medicines to the "already heavily drugged PD population."

Discussion of these mental health issues has advanced substantially in the six years since  Cohen asked the Director of the NIMH why there had been few studies of PD and depression or dementia, and no high quality studies (based on standards for evidence based medicine) defined as prospective, double blind, placebo controlled studies. The primary outcome measure for the placebo controlled study of Exelon was an Alzheimer's scale. It was questioned by some on the committee as not the best measure for PDD, but considered adequate given the strong treatment effects across all primary and secondary outcomes PPD is a result of cell death from alpha synuclein toxicity, while AD, which results in similar problems within the colonergic system, but results from placs and tangles in the brain. In this case. Exelon improves both types of dementia, due to action on the choleragenic system which is damaged in both degenerative processes.


Copyrightę 2012 Pipeline Project

All rights reserved. Revised: 01/26/12.