Doc, are you stating that the Cognision tool suite cannot or will not be used as an endpoint AD trial pass/fail device?
Yes, I am saying it will not be used as an endpoint in the current 2b/3 trial. It is not listed as a primary, secondary or other endpoint at clinicaltrials.gov. The original 2a trial did list it as an endpoint: Electroencephalographic activity, including event-related potentials (EEG/ERP) [ Time Frame: baseline, Day 1, 5, 11 of Period 1 and Day 1, 5, 11 of Period 2 and, Week 12, 36, 48, and 52 of the extension period ]
Why did they only report ERP data from early in the study and not at 36, 48 or 52 weeks? Was the data positive or negative at these points? Was there any correlation to MMSE or ADS-ADL or concentration at later time points? Perhaps the answer to those questions relates to the absence of P300 as an endpoint in the 2b/3.
PET is an expensive, time consuming and not w/o risk method.
PET is definitely expensive at $5000+. It is a little more time consuming but probably safe. Sure, patients would prefer the Cognision test... unfortunately it is much less accurate for the diagnosis of AD than amyloid PET. Indeed only 70% of patients with AD by amyloid PET are identified with p300 ERP. No one has ever correlated P300 to brain microscopic pathology. The phase 2b/3 is correctly using PET or CSF AB42 as an inclusion criteria. Amyloid PET matches pathology 90% of the time. The 2b/3 appears to be a well designed trial with appropriate primary endpoints and inclusion/exclusion criteria. If successful, share price will jump. However with only 9-12 sites this will take a long time. I still expect a second successful phase 3 study will be needed before any regulatory agency (TGA, EMA or FDA) approves the drug.
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