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georgejjl

05/30/20 9:22 PM

#253005 RE: biotechnician #253001

With the following endpoints Anavex can and will show significant benefits within just 14 weeks

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)

https://clinicaltrials.gov/ct2/show/NCT03774459

Good luck and GOD bless,

Steady_T

05/30/20 9:27 PM

#253006 RE: biotechnician #253001

My understanding is that PDD is different than AD in that AD is a disease of cognitive decline. The specific symptoms get worse and new ones come along as the decline continues. 2-73 may show improvement in measures of cognitive performance or show a slowing of the rate of decline. That is not to say that PD is not a disease of continued decline, it is. They are different.

In the PPD case there is specific symptom that is expected to show improvement in the short study period.

Specifically "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."

The difference is there is a clear and easily quantifiable symptom that can be measured accurately with PDD. AD doesn't have any equivalent measure that is widely accepted at this point. We have seen some ECG response potential measurements early on in the AD research program but those have not made it into the trial protocols.