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Methods for inhibiting cognitive deterioration in adults with down's syndrome

A technology for patients with Down syndrome, applied in drug combinations, pharmaceutical formulations, organic active ingredients, etc., can solve problems such as HPA axis activity damage and unclear meaning

Inactive Publication Date: 2004-12-22
CORCEPT THERAPEUTICS INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Impaired activity of the HPA axis in response to ACTH has been reported in individuals with DS (Murdoch et al., supra), but the significance of this finding is unclear

Method used

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Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0113] Example 1: Inhibition or reversal of cognitive decline in adult DS patients with mifepristone

[0114] [92] The following examples illustrate how to practice the method of the present invention.

[0115] patient selection

[0116] [93] Adults (18+) diagnosed with Down syndrome. A patient typically has normal Cortisol levels for his or her age.

[0117] Dosage regimen and administration of mifepristone

[0118] [94] used a glucocorticoid receptor (GR) antagonist, mifepristone, in this study. Administered at a dose of 200 mg per day. Subjects were dosed with 200 mg of mifepristone daily for six months and evaluated as described below. The dose can be adjusted if necessary and further evaluated periodically throughout the course of treatment.

[0119] [95] Mifepristone tablets are commercially available, eg, from Shanghai Hualian Pharmaceutical Co., Ltd., Shanghai, China.

[0120] Assessment of cognitive decline

[0121] [96] To characterize and assess the efficac...

Embodiment 2

[0122] Example 2: Measure cortisol levels

[0123] [97] To measure cortisol levels in the patient in Example 1, the afternoon cortisol test measurement was used and served as a baseline cortisol measurement. Cortisol levels were measured on Day 0, two weeks after drug treatment (Day 14), and at each observation up to six months, and at regular observations thereafter.

[0124] [98] Blood Cortisol levels were measured using the "Double Antibody Cortisol Kit" (Diagnostic Products Corporation, Los Angeles, CA). This test is a competitive radioimmunoassay in which 125 I-traced Cortisol competes with Cortisol from clinical samples at the antibody site and is performed essentially using reagents provided by the manufacturer and following the manufacturer's instructions. Briefly, blood was collected by venipuncture and serum separated from the cells. Samples were stored at 2-8°C for up to 7 days, or frozen at -20°C for 2 months. Samples can be brought to room temperature (15-28...

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PUM

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Abstract

This invention generally pertains to the field of psychiatry. In particular, this invention pertains to the discovery that agents capable of inhibiting the binding of cortisol to its receptors can be used in methods for preventing or reversing cognitive deterioration in adults with Down's syndrome. Mifepristone, a potent specific glucocorticoid receptor antagonist, can be used in these methods. The invention also provides a kit for preventing or reversing cognitive deterioration in a DS patient including a glucocorticoid receptor antagonist and instructional material teaching the indications, dosage and schedule of administration of the glucocorticoid receptor antagonist.

Description

[0001] Cross-References to Related Applications [0002] [01] This application claims priority to US Application Serial No. 60 / 316,653, filed August 31, 2001, the entire contents of which are incorporated herein by reference. field of invention [0003] [02] The present invention relates to the discovery of agents that inhibit the biological action of the glucocorticoid receptor and are useful in methods of preventing, reversing or inhibiting cognitive decline in adult patients with Down's syndrome. Background of the invention [0004] [03] Down's Syndrome (DS) is the most common genetic cause of mental retardation and was probably the first identified mental retardation-related disorder (Pulsifer, J Int Neuropsychol Soc 2: 159-76 (1996)). DS arises from one of three chromosomal abnormalities. The most common (95% of cases) Down syndrome is the result of trisomy 21, or an extra chromosome 21 in an otherwise diploid cell. Trisomy 21 usually results from nondisjunction of ch...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61J1/14A61K31/05A61K31/56A61K31/567A61K31/569A61K31/573A61K31/575A61K45/00A61P25/28
CPCA61K31/573A61K31/575A61K31/56A61K31/567A61P25/00A61P25/28A61P43/00
Inventor 约瑟夫K·贝拉诺夫
Owner CORCEPT THERAPEUTICS INC
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