Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Web – sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
2000-11-13
2004-06-08
Dodson, Shelley A. (Department: 1616)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Web, sheet or filament bases; compositions of bandages; or...
Reexamination Certificate
active
06746688
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to methods and apparatus for treatment of Parkinson's disease.
BACKGROUND OF THE INVENTION
Parkinson's disease (PD) is one of the most common neuro-degenerative diseases which affect the elderly.
The following is a representative list of references which discuss Parkinson's disease and therapeutic strategies:
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The prevalence of diagnosed PD in the population above the age of 55 is about 1.4% and it increases with age (Ref. 1). Moreover, Parkinsonian signs in the elderly are estimated to occur in 30% of the population over the age of 65 (Ref. 2). Although PD is considered a multisystem disease, it is mainly a movement disorder caused by a continuous, long lasting degeneration of the dopaminergic neurons that are located in the mesencephalic substantia nigra pars compacta. PD becomes symptomatic only after degeneration of about 60-80% of these dopaminergic neurons, or after the loss of about 90% of the striatal dopamine (Refs. 3, 4). Dopamine (DA), which is produced within the substantia nigra, reaches the striatum via the nigro-striatal tract and is released at the striatal synapses. DA deficiency in the striatum, due to the degeneration of the dopaminergic neurons in the substantia nigra, is considered to be the cause of PD. Consequently, the most effective treatment of PD is Levodopa (LD), which is converted to DA by enzymatic decarboxylation. Inhibition of the peripheral aromatic amino acid decarboxylase by carbidopa (an inhibitor that cannot penetrate the blood-brain-barrier) improves dramatically the results of the treatment. However, the currently available LD preparations are effective only for a relatively short period and may be even deleterious, under certain conditions (as will be explained below).
Administration of LD is especially successful during early stages of the disease. Adverse effects of LD, such as dyskinesias and hallucinations that occur at early stages of the disease are dose-dependent. These adverse effects are attributed to hypersensitivity of denervated striatal dopaminergic receptors to exogenous dopamine (Ref. 5). At late stages of the disease additional types of adverse effects appear as the response to LD becomes unpredictable, fluctuative and the duration of the response is reduced. Motor fluctuations appear after about 4-5 years from the introduction of LD therapy in 24%-84% of the patients (Ref. 6). The most common and disabling motor complications are: 1) “wearing-off” fluctuations; 2) “on-off” fluctuations and 3) peak-
Heldman Eliahu
Kushnir Moshe
Dekel Patent Ltd.
Dodson Shelley A.
George Konata M.
Klein David
Neuroderm Ltd.
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