Methods for the Diagnosis and Treatment of Neurological and Neurodegenerative Diseases, Disorders and Associated Processes
AssigneeC2N Diagnostics
InventorsTim West, Andrew C. Paoletti
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Abstract
The invention generally relates to methods for the diagnosis and treatment of neurological and neurodegenerative diseases, disorders, and associated processes. Specifically, the present invention is directed toward methods to determine prognosis, diagnosis or efficacy of a therapeutic regimen by using a detectable label to measure levels of alpha-synuclein.
Claims17
A method to determine the prognosis, diagnosis, efficacy of a therapeutic regimen, or predict subject response to a therapeutic agent to treat an alpha-synuclein related disease or disorder in a subject comprising contacting a biological sample from a subject with a labeled moiety to detect the level of alpha-synuclein in the sample wherein the level is compared with a reference standard level, wherein a difference in the level in the sample as compared to the reference level allows one to determine the prognosis, diagnosis, efficacy of the therapeutic regimen or predict subject response to a therapeutic agent to treat an alpha-synuclein related disease or disorder.
An in vivo method to identify a therapeutic agent to treat an alpha-synuclein related disease or disorder comprising:
- (a) administration of a labeled moiety and a therapeutic agent to a subject suspected of having an alpha-synuclein related disease or disorder or cells, wherein the therapeutic agent is selected from the group consisting of:
- small molecule inhibitors of alpha-synuclein, antibodies against alpha-synuclein, alpha-synuclein clearance activators, sirtuin 2 inhibitors, proteomsome inhibitors, small molecule inhibitors of alpha-synuclein polymerization, L-DOPA, cholesterylester transfer protein (CEPT) inhibitors, metalloprotease inhibitors, cholinesterase inhibitors, NMDA receptor antagonists, hormones, neuroprotective agents and cell death inhibitors;
- (b) collection of a biological sample from the subject and a corresponding normal sample or the cells and a corresponding normal samples;
- (c) measurement of labeled alpha-synuclein and unlabeled alpha-synuclein from the subject and corresponding normal sample;
- (d) determination of the ratio of labeled alpha-synuclein to unlabeled alpha-synuclein from the subject and corresponding normal sample or the cells and a corresponding normal samples;
- (e) determination of alpha-synuclein metabolism from the ratios of step (d);
- and
- (f) comparison of the alpha-synuclein metabolism from the subject to the alpha-synuclein metabolism from the corresponding normal sample or the cells and a corresponding normal samples;
- wherein a change in alpha-synuclein metabolism of the subject compared to the corresponding normal sample or a change in alpha-synuclein metabolism of the cells compared to the corresponding normal sample is indicative of the identification of a therapeutic agent to treat an alpha-synuclein related disease or disorder;
- thereby identifying a therapeutic agent to treat an alpha-synuclein related disease or disorder an alpha-synuclein related disease or disorder.
A kit for determination of prognosis, diagnosis or efficacy of a therapeutic regimen in a subject having or suspected of having an alpha-synuclein related disease or disorder comprising one or more labeled moieties and a means for administering the one or more moieties to a subject, a means for obtaining a biological sample and instructions for determining the ratio of labeled to unlabeled alpha-synuclein.
Dependencies are inferred from the claim text.