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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.
Click here to read the entire announcement,
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