Summary of the Cecchi patent application...as paid for by Anavex(applicant).
Thanks nidan for posting the link to the Cecchi patent app.
I am intrigued by the testing that the inventor Cecchi discusses. He describes a lot of the dosing and testing that this board questioned and guessed about, several months back.
He also gives measures of 2-73 efficacy, and the data, which are interesting as measures against current SOC, and whether 2-73 is really effective!
I always like data, because it is the science that proves 2-73 efficacy or not. And Cecchi describes more than I have seen before for 2-73.
Here are my notes from the patent for anyone that is interested. I paraphrased a lot and summarized. Many of the comments in parentheses are my comments or questions. I like to not only compare 2-73 to normal AD patients, but also to know how much 2-73 has moved the patient back to normal. So I sometimes calculated this value myself below.
Disclaimer...Use my notes at your own risk!
Definitions
DSC Differential Scanning Calorimeter
EEG ElectroEncephalograph -used to access effects for 2-73
ERP Event Related Potentials - Voltage changes locked to some physical occurence (ex.like hearing a tone).
PAF Peak Alpha Frequency - An EEG measurement. AD patients have reduce PAF which correlates to reduced cognitive performance.
P300 A battery of tests measuring patient response to audible tones.
Efficacy tests had 2-73 administered for 36 days to 12 patients with mild to moderate AD as an add-on therapy to patients that were already on donepezil(the current SOC).
Doses were alternately given to each patient both orally and intravenously. The oral doses were 30mg or 50mg and the IV dose was 3mg or 5mg.
ERPs as measured via an EEG provide a sensitive and accurate measure of the cognitive effects of early AD, and was used to assess the efficacy of 2-73.
Here baseline refers to the patients measurements before dosing.
Auditory P300 testing measures patient EEG response to audible tones. Used a COGNISION (Neuronetrix) headset. (Nothing special I think.)
The ERP waveform for the 12 patients, after 36 days on 2-73, more closely resembled healthy subjects. This is seen in figure 5.
Figure 6 and table 1, show the auditory P300 amplitude data for the baseline AD patient, the 36 day 2-73 patient, and a control (healthy) patient. The 2-73 patient shows a 38% improvement over baseline, and (my calc) is 73% back to normal! (wow!)
Table 2, show the button pressing data for the baseline AD patient, the 36 day 2-73 patient, and a control (healthy) patient. This is some type of button response test.
The data shows the 2-73 patients accuracy was only very slightly better than baseline. (Statistically in the noise?)
The data shows the 2-73 patients false alarms were nearly two times better than normal control. (This seems very suspect to me. How is it better than normal?)
The data shows the 2-73 patients reaction time improved 43% back to normal (my calc).
Figure 7 compares the P300 amplitude performance of a control group, a 2-73 group(12 patients 36 days) and a donepezil group(published data).
After one month the 2-73 group is a little better than the donepezil group, but at 1 month (versus donepezils slightly worse meaurement at 6 months). More importantly, both are improving over the control group.
The claims, the heart of the patent, are just about administering A2-73 at different doses and time intervals.
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