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Alzheimer's, Dementia & Mental Health
Alzheimer's Dementia Drug Approved for Parkinson's
Dementia
Exelon gains FDA approval as first to treat this
dementia
June 28, 2006 Exelon (rivastigmine tartrate), a
drug already used to treat mild-to-moderate dementia associated with
Alzheimer's disease, got the nod yesterday from the Food and Drug
Administration to become the first medication available for the
treatment of this condition when associated with Parkinson's disease. It
is estimated that about 0.2 percent to 0.5 percent of senior citizens
over age 65 are affected by Parkinson's dementia and experience such
symptoms as impairments in executive function, memory and attention.
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Alzheimer's, Dementia & Mental Health
News |
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Parkinson's disease is a disorder of the central
nervous system and, according to the National Parkinson Foundation (NPF),
it affects 1.5 million Americans. Approximately 40% of patients with
Parkinson's disease are estimated to also develop dementia, which can
have a devastating effect on patients and their families.
The risk for developing dementia among Parkinson's
patients is approximately four to six times higher than among elderly
people without this disease. According to the NPF, dementia is one of
the complications most feared by Parkinson's disease patients and their
caregivers.
"Parkinson's disease dementia takes a significant
emotional, economic and social toll on patients and their families,"
said Laura Marsh, MD, Director, Clinical Research Program Johns Hopkins
Morris K. Udall Parkinson's Disease Research Center and member of the
American Parkinson Disease Association Scientific Advisory Board.
"With current Parkinson's disease treatments, we
are often able to manage the movement symptoms of the disease, but there
has been a significant gap in our ability to treat dementia in these
patients, which is why this approval is such a welcome development."
"It's been recognized for almost a decade that the
dementia of patients with Parkinson's disease differs from the dementia
of patients with Alzheimer's," said Dr. Steven Galson, Director of FDA's
Center for Drug Evaluation and Research, "but until now, there has been
no treatment that has been shown to be effective specifically for the
dementia associated with Parkinson's Disease. Today's approval of Exelon
helps to fill this medical need."
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About Parkinson's Disease Dementia |
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Parkinson's disease is a chronic and
progressive disease of the nervous system.
The four primary
symptoms of Parkinson's include: rigidity of the limbs; tremor
(trembling or shaking) of a limb, especially when the body is at
rest; slow movement and postural instability, which is often
perceived as unsteadiness or lack of balance.
The primary symptoms of Parkinson's disease
dementia include cognitive impairment and neuro-psychiatric
symptoms (e.g., depression, hallucinations, anxiety and apathy).
These symptoms impact the patient's quality of life, course of
the disease and caregiver distress.
As with Alzheimer's disease,
Parkinson's disease dementia is associated with a cholinergic
deficit, which results in decreased transmission of signals
between nerves in the brain, especially those that rely on the
neurotransmitter acetylcholine.
This deficit contributes to the
cognitive and behavioral problems observed in these patients. |
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The approval of Exelon for the treatment of
Parkinson's dementia is based on the results of a randomized,
placebo-controlled clinical study with 541 patients who showed symptoms
of mild to moderate dementia two years or later after their diagnosis
for Parkinson's disease. At the end of the 24-week trial, the condition
of the Exelon-treated patients, as shown on a scale that measures mental
processes, was significantly better than the condition of the patients
on placebo.
"The outcomes demonstrated in this trial by
patients taking Exelon can translate into meaningful gains -- such as
taking a more active role in everyday life, interacting with loved ones,
and maintaining independence longer -- all of which can make a real
difference for both patients and their families," said Jeffrey Cummings,
MD, Professor of Neurology at the University of California, Los Angeles.
"Exelon has consistently demonstrated efficacy in the treatment of
Alzheimer's disease patients and can now also benefit individuals living
with Parkinson's disease dementia."
The use of Exelon has been associated with
significant gastrointestinal adverse reactions, according to the FDA. In
clinical trials, 47 percent of the patients treated with the drug
developed nausea, and 26 percent of women and 18 percent of men on high
doses of Exelon experienced significant weight loss. Other common
adverse events reported by patients on Exelon include vomiting,
anorexia, dyspepsia and asthenia (loss of strength). In some patients
with Parkinson's disease, treatment with Exelon was associated with a
worsening of tremor.
Exelon is manufactured by Novartis Pharmaceutical
Corp. in East Hanover, NY. For more information visit
http://www.novartis.com/ .
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