Top-line results from the Anavex PDD trial should be very easy and quick to analyze using computerized statistical analysis programs that are commercially available.
Below is the list of endpoints for the trial to determine the top-line results:
Outcome Measures:
Primary Outcome Measures: Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention [ Time Frame: 14 weeks ] Change from Baseline to End of Treatment in Continuity of Attention as measured by Cognitive Drug Research (CDR) Computerized Assessment System Continuity of Attention test
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: 14 weeks ] Assess the safety and tolerability of ANAVEX2-73 compared to placebo
Secondary Outcome Measures: MDS-UPDRS Part III Total Score (Motor Scores) [ Time Frame: 14 weeks ] Change from baseline to End of Treatment as measured by MDS-UPDRS Part III Total Score (Motor Scores)
SDS-CL-25 [ Time Frame: 14 weeks ] Incidence of sleep disorders symptoms (SDS-CL-25)