Methodology Study of Novel Outcome Measures to Assess Progression of ALS
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abstract
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The primary objectives of the study are to estimate and rank-order
the longitudinal standardized mean changes over 6 months and over 12
months, for a set of outcome measures administered to participants
with amyotrophic lateral sclerosis (ALS), in order to identify
measures that are more sensitive to disease progression than
Amyotrophic Lateral Sclerosis Functional Rating Scale-Revised
(ALSFRS-R). The secondary objectives of this study are: To evaluate
the test-retest reproducibility of each outcome measure; To
determine correlations between 6 and 12-month changes in all
exploratory measures with 18 and 24-month changes in ALSFRS-R and
survival; To assess correlations between/among the various measures;
To obtain biological samples in order to identify molecular
correlates to the clinical measures and to further characterize
previously identified and novel molecular biomarkers of disease
progression for incorporation into future clinical studies.
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type of project
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clinical studies
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status
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completed
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start of project
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2016
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end of project
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2019
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responsible person
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Markus Weber, Christoph Neuwirth
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