Systems for clinical trials

A system, action technique, applied in the field of physiologic and psychological test results for presumptive disease-modifying treatments
CN101911081AInactive Publication Date: 2010-12-08WISTA LAB LTD
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Patent Information

Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
WISTA LAB LTD
Publication Date
2010-12-08
Estimated Expiration
Not applicable · inactive patent

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Abstract

The invention provides methods and systems for assessing the efficacy of a pharmaceutical which is putatively disease modifying of a cognitive disorder, for use in the treatment or prophylaxis of that cognitive disorder, the method comprising the steps of: (1) stratifying a subject group into at least 2 sub-groups according to a baseline indicator of likely disease progression, (2) treating members of each subject group with the pharmaceutical for a treatment time frame, (3) deriving psychometric and optionally physiological outcome measures for each treated patient group, (4) comparing the outcomes at (3) with a comparator arm of said sub-groups which is optionally a placebo or minimal efficacy comparator arm, (5) using the comparison in (4) to derive an efficacy measure for the pharmaceutical. The methods and systems of the invention address problems such as low rate of decline over the treatment time-frame of patients who have mild-disease severity at baseline and biased withdrawal, particularly in the placebo / comparator treatment arm.
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Description

technical field

[0001] The present invention relates generally to methods for use in evaluating the efficacy of drug treatments for cognitive impairment, and in particular to physiological and psychological test results for putatively disease-modifying treatment. Background technique

[0002] Clinical Trials of Disease-Modifying Therapies

[0003] It has been previously indicated that 3,7-diaminophenothiazine (DAPTZ) compounds, including methylene blue (“MTC, methylthioninium chloride”), inhibit Tau protein aggregation and disrupt PHF structure, as well as reverse the proteolytic stability of the PHF core (See WO96 / 30766, F Hoffman-La Roche). Such compounds are disclosed to be useful in the treatment and prevention of various diseases including Alzheimer's disease (AD) and Lewy body disease. The rationale for the potential efficacy of DAPTZ compounds in the treatment and prevention of disorders such as AD is based on their ability to act on the primary neurofibrillary path...

Claims

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