279 Assessment of various biomarkers may provide supportive evidence for a drug that has an 280 established clinically meaningful benefit, but the effects on biomarkers in AD are not sufficiently 281 well understood to provide evidence of a persistent effect on disease course. 282 283 Currently, there is no consensus as to particular biomarkers that would be appropriate to support 284 clinical findings in trials in early AD. For this reason, sponsors at present have insufficient 285 information on which to base a hierarchical structuring of a series of biomarkers as secondary 286 outcome measures in their trial designs. Sponsors are therefore encouraged to analyze the results 287 of these biomarkers independently, though in a prespecified fashion, with the understanding that 288 these findings will be interpreted in the context of the state of the scientific evidence at the time 289 of a future marketing application.
Early Alzheimer’s Disease: Developing Drugs for Treatment Guidance for Industry
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