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Systems for clinical trials

A system, action technique, applied in the field of physiologic and psychological test results for presumptive disease-modifying treatments

Inactive Publication Date: 2010-12-08
WISTA LAB LTD
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Although different endpoints were used in this study (typically using the UPDRS scale to measure the severity of PD-related symptoms), the underlying questions are the same, as they arise from the inherently slowly progressive kinetics of neurodegenerative diseases

Method used

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  • Systems for clinical trials
  • Systems for clinical trials
  • Systems for clinical trials

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0201] Example 1 - Disease Severity and Rate of Disease Progression at Baseline

[0202] It has been generally recognized in the literature that disease severity or stage is an important predictor of disease progression (recently reviewed in Schaufele, M., Bickel, H., Weyerer, S. (2002) Which factors influence cognitive decline in older adults suffering from dementing disorders? International Journal of Geriatric Psychiatry, 17: 1055-1063).

[0203] However, the rember TMThe study is the first to prespecify CDR severity at baseline as a stratification covariate in the primary outcome analysis. Subjects were divided into two groups: subjects with mild CDR at baseline (including 3 [1% of randomized total] subjects who were CDR-questionable at baseline) and subjects with moderate CDR at baseline of subjects. Although CDR has been previously advocated as a means of classification (Berg, L., Danziger, W.L., Storandt, M., Coben, L.A., Gado, M., Hughes, C.P., Knesevich, J.W., Bo...

Embodiment 2

[0224] Example 2 - Cognitive Reserve

[0225] Although there was a general association between increased brain pathology burden and cognitive decline, this association did not explain all the variance in the data. Attempts to explain the variability have been stated in terms of the concepts of "brain reserve" or "cognitive reserve", which involve two different theoretical formulations (Stern, Y. (2002) What is cognitive reserve? Theory and research application of the reserve concept. Journal of the International Neuropsychological Society, 8:448-460). The first is the passive brain reserve model, where reserve is defined by brain size or neuronal count. It is described as passive because it is defined in terms of the amount of damage or burden an individual can withstand before clinical symptoms manifest. The second, or active cognitive reserve model, states that the brain is capable of compensating for pathological load by recruiting other processes to perform disease-com...

Embodiment 3

[0232] Example 3 - Psychometric testing failed to demonstrate in CDR mild AD over 24 weeks of study clear therapeutic efficacy

[0233] Analytical method

[0234] Two methods of analysis were provided for each OC and LOCF analysis: linear least squares and linear mixed-effects models for change in ADAS-cog score from baseline over 24 weeks. After the baseline severity term was found to be highly significant in all initial analyses, further analyzes were performed that included a treatment:severity:interaction term. Severity (defined by CDR) was used as a baseline grouping variable. A further ANCOVA analysis of the 24-week LOCF data was performed using only the analysis of ADAS-cog score change at the 24-week evaluation point (using both non-interaction and interaction models).

[0235] ITT / OC Analysis

[0236] non-interaction model

[0237] Treatment Effects in Linear Least Squares and Linear Mixed Effects Non-Interaction Models Applied to the Whole ITT / OC Population D...

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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.

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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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): G06F19/00A61B5/00
CPCG06Q99/00G06F19/363G06F19/3437G16H10/20G16H50/50
Inventor 克劳德·M·维希克戴蒙·J·维希克罗杰·T·斯塔夫艾莉森·D·默里
Owner WISTA LAB LTD
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