Anavex Life Sciences Corp (AVXL)

[nidan7500]

Extracts from Patent app text:

[0041] Subjects were tested using a three-stimulus oddball paradigm. Stimuli comprised of standard tones (1000 Hz), target tones (2000 Hz) and unexpected distractor tones (white noise) that were played with probabilities of 0.75, 0.15, and 0.10. Tones were presented in pseudorandom order, so that target and distractor tones were never presented sequentially. Subjects were instructed to respond to the target stimuli by pressing a button with their dominant hand. For each test, between 300 and 400 stimuli were presented binaurally through insert ear phones at 70 dB volume. The tone duration for each stimulus was 100 ms with rise and fall times of 10 ms. The interstimulus interval was randomized between 1.5 and 2 s. Electroencephalographic (EEG) activity was recorded from seven electrode sites (Fz, Cz, Pz, F3, P3, F4, and P4) of the international 10-20 system using a COGNISION.TM. Headset (Neuronetrix). Electrodes were referenced to averaged mastoids (M1, M2) and Fpz served as the common electrode. The headset used for data collection had been validated to perform reliable ERP recordings when skin contact impedance was below 70 k.OMEGA.. Impedance was automatically checked at all electrodes after each target or distractor tone, and was kept below this limit throughout each test. Data was collected from -240 to 1,000 ms around the stimuli, digitized at 125 Hz, and bandpass filtered from 0.3 to 35 Hz. An automatic artifact threshold detection limit of .+-.100 .mu.V was set for the tests. Trial sets of a deviant tone and the immediately preceding standard tones (epoch sets) with artifacts exceeding the threshold were rejected in real time and immediately repeated.

[0042] FIG. 5 illustrates P300 ERP wave data for twelve patients at baseline and day 36 following the on-off-on ANAVEX2-73 dosing regimen, without any dose optimization. FIG. 5 also illustrates data for a healthy control group obtained from a manuscript that was recently submitted by Cecchi et al. to the journal Alzheimer's & Dementia. The P300 ERP wave data indicates that administration of ANAVEX2-73 improved measured cognitive performance as compared to the baseline data. Additionally, the P300 ERP wave plot for subjects undergoing the ANAVEX2-73 dosage regimen more closely resembled the P300 ERP wave plot obtained for healthy subjects.

[0043] FIG. 6 illustrates P300 amplitude data for twelve patients at baseline and day 36 following the on-off-on ANAVEX2-73 dosing regimen, as compared to the healthy control group. The same data is provided in Table 1. As shown in Table 1, the P300 amplitude for subjects undergoing the ANAVEX2-73 dosage regimen increased by 38% as compared to the baseline P300 amplitude. Additionally, the P300 amplitude for subjects undergoing the ANAVEX2-73 dosage regimen more closely resembled the P300 amplitude data obtained for the healthy control group than the baseline P300 amplitude data.