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Replies to post #141888 on Anavex Life Sciences Corp (AVXL)
FDA supports and endorses the use of diagnostic criteria that are based on a contemporary 102 understanding of the pathophysiology and evolution of AD. The characteristic 103 pathophysiological changes of AD greatly precede the development of clinically evident findings 104 and progress as a continuous disease process through stages defined initially only by those 105 pathophysiological changes and then by the development of subtle abnormalities, detectable 106 using sensitive neuropsychological measures. These are followed by the development of more 107 apparent cognitive abnormalities, accompanied by initially mild and then more severe functional 108 impairment. In part because of failures of clinical trials intended to alter disease progression in 109 later stages of AD, there is an increased focus on evaluating drug treatments for AD in the 110 earliest stages of the disease. Diagnostic criteria that reliably define a population with early AD, 111 including the earliest stages characterized only by pathophysiological changes, are suited to the 112 evaluation of drugs intended to delay or prevent the emergence of overt symptoms. 113 114 Important findings applicable to the categorization of AD along its continuum of progression 115 include the presence of pathophysiological changes as measured by biomarkers, the presence or 116 absence of detectable abnormalities on sensitive neuropsychological measures, and the presence 117 or absence of functional impairment manifested as meaningful daily life impact that present with 118 subjective complaints or reliable observer reports(RWE). Although FDA recognizes that variations in 119 the selection and application of clinical characteristics and biomarkers may lead to the 120 identification of patients who are at somewhat different stages of a progressive disease process, 121 the following categories are conceptually useful for the design and evaluation of clinical trials in 122 different stages of AD:
Assessment of various biomarkers may provide supportive evidence for a drug that has an 279 established clinically meaningful benefit, but the effects on biomarkers in AD are not sufficiently 280 well understood to provide evidence of a persistent effect on disease course. 281 282 Currently, there is no consensus as to particular biomarkers that would be appropriate to support 283 clinical findings in trials in early AD. For this reason, sponsors at present have insufficient 284 information on which to base a hierarchical structuring of a series of biomarkers as secondary 285 outcome measures in their trial designs. Sponsors are therefore encouraged to analyze the results 286 of these biomarkers independently, though in a prespecified fashion, with the understanding that 287 these findings will be interpreted in the context of the state of the scientific evidence at the time 288 of a future marketing application.
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