Chemistry: molecular biology and microbiology – Measuring or testing process involving enzymes or... – Involving nucleic acid
Reexamination Certificate
1999-06-01
2001-04-03
Prouty, Rebecca E. (Department: 1653)
Chemistry: molecular biology and microbiology
Measuring or testing process involving enzymes or...
Involving nucleic acid
C435S025000, C435S189000
Reexamination Certificate
active
06210895
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to a method for predicting, diagnosing, and prognosticating dementing diseases such as Alzheimer's Disease (AD) and Age-Associated Cognitive Decline (AACD).
BACKGROUND OF THE INVENTION
Alzheimer's Disease is a neurodegenerative disease which causes dementia. The period from first detection of AD to termination can range from a few years to 15 years, during which time the patient progressively suffers loss of both mental function and control of bodily functions. There is significant variability in the progress of the disease. While the majority of patients have a gradual, inexorable progression (losing on average 3 to 4 points on the 30 point Folstein mini-mental state score annually), approximately 30% of AD cases have a prolonged stable initial plateau phase lasting several years (Haxby et al., 1992). A subgroup of patients has a fulminant, rapidly progressive downhill course over several years (Mann et al., 1992). Other patients (about 10% of cohorts) remain slowly progressive, showing only gradual decline from year to year (Grossi et al., 1988). The pathological, chemical, and molecular bases of this heterogeneity remain undetermined. Recognition of the variability of AD progression represents an important clinical insight, and may explain the diagnostic difficulties presented by “atypical” cases.
Attempts at predicting the onset of AD or monitoring its progression have met with limited success. While in certain cases, there is a familial manifestation of the disease, it appears that the majority of AD cases are non-familial, and no simple genetic marker for the disease has yet been determined. Much research has focused on the protein beta-amyloid, deposits of which are found in the brains of AD victims.
Methods of predicting, diagnosing in its very early stage, and prognosticating AD and other dementing diseases are needed.
SUMMARY OF THE INVENTION
It is a goal of the present invention to provide a method for predicting, diagnosing, and prognosticating AD and other dementing diseases.
In one embodiment, the invention provides a method for assessing dementing diseases in a patient which comprises determining the concentration of heme oxygenase-1 (HO-1) and/or a nucleotide sequence encoding HO-1, in tissues obtained from a patient, and comparing said concentration with the corresponding concentration of HO-1 and/or an HO-1 encoding nucleotide sequence in corresponding tissues obtained from at least one control person, wherein such method is used to predict the onset of, diagnose, or prognosticate dementing diseases.
In another embodiment, the invention provides a commercial package comprising means for determining the concentration of heme oxygenase-1 (HO-1) and/or a nucleotide sequence encoding HO-1, in tissues obtained from a patient, and instructions for comparing said concentration with an established standard of the corresponding concentration of HO-1 and/or an HO-1 encoding nucleotide sequence in corresponding tissues obtained from at least one normal age-matched control person or from the patient at an earlier time.
The tissues to which the method can be applied include plasma, cerebrospinal fluid, lymphocytes and fibroblasts.
Advantageously, embodiments of this invention provide an easily administered blood or cerebrospinal fluid test which is used to predict, diagnose, or prognosticate AD and other dementing diseases.
REFERENCES:
patent: 2222174 (1996-06-01), None
Grossi et al , Clinical and behavioral variants of Alzheimer type dementias, II International Symposium, Eds, Paris 1988.
Schipper et al., Evaluation of heme oxygenase-1 as a systemic biological marker of sporadic AD, Neurology, 1297-1304, 2000.
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Grossi, D., et al. (1988) Senile dementias. II International Symposium (pp. 97-99). Paris: John Libbey Eurotext.
Haxby JV, et al. (1992) Individual trajectories of cognitive declline in patients with dementia of the Alzheimer type. J Clin Exp Neuropsychol 14:575-592. Abstract.
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Schipper HM, et al. (1995) Expression of heme oxygenase-1 in the senescent and Alzheimer-diseased brain. Ann Neurol 37:758-768.
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Schipper HM, et al. (1997) Blood Heme Oxygenase-1 Levels are Decreased in Alzheimer's Disease, Soc. Neuroscience 23:1641 (Abs. 637.10).
Schipper HM, et al. (1999) Further Evaluation of Heme Oxygenase-1 as a Biological Marker in Alzheimer's Disease, Neurology. 52:A126 (Suppl. 2) (Abs. P02.032).
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Chertkow Howard
Schipper Hyman M.
Lorusso & Loud
Monshipouri M.
Prouty Rebecca E.
The Sir Mortimer B. Davis-Jewish General Hospital
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