Anavex Life Sciences Corp (AVXL)

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Hmm...

185 B. Clinical Endpoints for Early AD Trials in Stage 2 Patients
186
187 In patients in the earliest clinical stages of AD (Stage 2 patients), where only subtle cognitive
188 deficits detected on sensitive measures of neuropsychological performance are present, and there
189 is no evidence of functional impairment, it may be difficult to establish a clinically meaningful
190 effect on those subtle cognitive deficits during the course of a trial of reasonable duration.
191 Nonetheless, a possible approach is to conduct a study of sufficient duration to allow the
192 evaluation of the measures discussed above for Stage 3 patients. As patients transition to Stage 3
193 during participation in the trial, the principles applicable to outcome assessment for Stage 3
194 would apply.
195
196 Alternatively, and in view of the rapidly and continually expanding body of knowledge
197 concerning AD, FDA will consider strongly justified arguments that a persuasive effect on
198 sensitive measures of neuropsychological performance may provide adequate support for a
199 marketing approval. Given the panoply of available neuropsychological tests, a pattern of
200 putatively beneficial effects demonstrated across multiple individual tests would increase the
201 persuasiveness of the finding; conversely, a finding on a single test unsupported by consistent
202 findings on other tests would be less persuasive. A large magnitude of effect on sensitive
203 measures of neuropsychological performance may also increase their persuasiveness. It would
204 generally be expected that such arguments would be supported by similarly persuasive effects on
205 the characteristic pathophysiologic changes of AD, as discussed below for Stage 1 patients.

https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM596728.pdf