Anavex Life Sciences Corp (AVXL)

[abew4me]

Excellent post by Steady_T.

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The FDA has said that it wants to move to smaller trials. 509 > 300.

Also the trial specifies a number of other outcomes that will aid in confirming the diagnosis, demonstrate physiological changes, genetic profiles etc. All of which can serve as supporting data for the primary endpoints.

The need for large AD trials was driven by the difficulty of distinguishing AD from other CNS diseases, the variability in the endpoint measure tests, and the lack of qualified biomarkers.

The Anavex AD trial addresses each of those issues with the other outcomes section of the trial. If the trials data is good I don't think the n size will be an issue because of all the data that is being collected to support the primary endpoints. We will find out how the FDA sees it.

Other Outcome Measures:
Number of participants with change of brain volume assessed by MRI [ Time Frame: 48 weeks ]
To evaluate the effect of ANAVEX2-73 on structural and Arterial Spin Labeling (ASL) MRI scan assessments characteristic for AD pathophysiology compared to placebo over a 48-week treatment duration

Blood assessment [ Time Frame: 48 weeks ]
Blood assessment from baseline and compared to placebo at +48 weeks: Abeta40, Abeta42, T-tau, NFL, YKL-40, BACE1 concentration

CSF assessment [ Time Frame: 48 weeks ]
Changes in CSF parameters (Abeta40, Abeta42, T-tau, P-tau, NFL, YKL-40, neurogranin, BACE1 concentration) characteristic for AD pathophysiology from baseline and compared to placebo at

+48 weekstreatment differences within subgroups will be performed


Number of participants with pre-specified genetic variants [ Time Frame: 48 weeks ]
AD relevant pre-specified genetic variants will be assessed. Statistical testing of treatment differences within subgroups will be performed

RSCAQ sleep score [ Time Frame: Weeks 0, 4, 12, 24, 36, and 48 ]
To evaluate whether ANAVEX2-73 improves sleep continuity as assessed on a serial basis (weeks 0, 4, 12, 24, 36, and 48) with a questionnaire that assess reported sleep continuity (RSCAQ)

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