Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Nitrogen containing other than solely as a nitrogen in an...
Reexamination Certificate
1997-05-07
2001-05-15
MacMillan, Keith D. (Department: 1617)
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Nitrogen containing other than solely as a nitrogen in an...
C514S428000, C514S874000
Reexamination Certificate
active
06232350
ABSTRACT:
BACKGROUND AND SUMMARY OF THE INVENTION
The present invention relates to a preparation for the treatment and prevention of dementia disorders, particularly disorders caused by regressive cellular changes.
The appearance of such disorders becomes more likely with increased age. The consequence of this is that, given an increasing life expectancy and a resulting growing proportion of older people among the population, the prevalence of dementia disorders caused by old age is constantly increasing. Manifestations of aging in connection with the central nervous system are accompanied by a multitude of structural and functional alterations. These include, for example, cerebral shrinkage and loss of brain weight, nerve-cell degenerations, various amyloid formation, and lesions of the cerebral vessel-connective tissue apparatus.
The above-named alterations affect above all persons who, in the wider sense, are afflicted with Alzheimer's disease. This means for one thing that when Alzheimer's disease is present, the above-named alterations occur in a particularly strong way, and, for another thing, that the above-mentioned alterations can reinforce the symptoms of Alzheimer's disease or encourage the appearance of these. Lesions of the cerebral vessel-connective tissue apparatus are, for example, the causes of Multi-Infarct Dementia (MID). At present, vigorous debate is still going on about the causes of Multiple Sclerosis (MS).
Parkinson's Disease can be mentioned as another neurological afflication. This disorder appears together with a pronounced dopamine deficiency in the region of the substantia nigra and in the corpus striatum. The cause of this disorder is a degeneration of dopaminergic projection neurons in the substantia nigra and corpus striatum. In this disorder, symptoms of dementia have also been described.
In addition to the already-mentioned dementia disorders, a large number of other general degeneration disorders can also occur, such as “impaired brain function of old age” (IBFO). The probability that strokes will occur likewise becomes greater with increasing age. Furthermore, diseases based on arteriosclerotic vessel changes can also be mentioned.
Another effect that occurs more with an increasing process of aging is a decrease in the adaptability of the “stress management system.” This endogenous system for managing stress is located at the sites of the hypothalamus-hypophysis-adrenal glands. The mechanism of action of this stress management system is based essentially on the fact that when injuries, infections, or psychosocial stress occur, for example, the human body reacts by releasing a large number of mediators, which act with one another in a finely balanced way to restore homeostasis.
These mediators ensure, among other things, that any increased cell activity is again reduced, so as to prevent a prolonged overstraining of the cells that could lead to cellular damage and, in the extreme case, to the dying-off of cells.
Examples of such mediators are the steroid hormones. These hormones bind specifically to receptors, which are disposed in the region of the cellular nucleus. This binding to receptors induces a broad spectrum of metabolic processes. Moreover, a series of neuro-endocrino-immunological interactivities also occur, which provide security for the integrity and the health of the affected individual.
Until now, no preparation has been known that has only mild side effects but can prevent the occurrence of manifestations of degeneration caused by old age, or in the case of a disorder that has already appeared, can counteract the further progression of the disorder or can treat the disorder.
Therefore, an object of the present invention is to specify a preparation of the initially-named type which will have a high efficacy in the treatment and prevention of dementia disorders while producing only mild side effects.
This object is attained in accordance with the invention by administering a drug that contains at least one steroidal antagonist as the active agent.
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IRCS Medical Science: Clinical Medicine, vol. 4, No. 3, G. Delitala et al., “Pituitary-Gonadal Response To Clomiphene Citrate In Parkinsonism”, (1976), p. 113.*
International Journal of Geriatric Psychiatry, vol. 2: 125-126, J.J. Oram et al, “Treatment of Senile Dementia With Thyrotrophin Releasing Hormone and Clomiphene”, (1987).*
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Altramed Holdings, Ltd.
Harness & Dickey & Pierce P.L.C.
MacMillan Keith D.
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