http://www.mdedge.com/clinicalneurologynews/a...ward-after
" The P300 wave amplitude showed a small initial bump from about 6 to 7 microvolts by 4 weeks, and then a dip back down to about 6 microvolts until about week 32. Thereafter it steadily improved, landing at around 8 microvolts by 57 weeks – a level usually seen in healthy age-matched controls. There was a significant separation from the P300 decline seen in a matched historical Alzheimer’s cohort, which dropped to about 4 microvolts over a 52-week period while patients were taking donepezil.
The study employed a second historical control group in another cognitive assessment using the Computerized Cogstate Alzheimer’s Battery. All subjects in the large Australian prospective cohort study, called AIBL (Australian Imaging, Biomarkers & Lifestyle Flagship Study of Ageing), were taking standard of care Alzheimer’s drugs. Compared with that cohort, the ANAVEX 2-73 group experienced benefits in processing speed, attention, and working memory, which became statistically significant at week 31 and continued to grow.
At 57 weeks, the mean MMSE score was stable, hovering around the baseline of 20. The ADCS-ADL declined slightly, from a mean of around 70 to around 65.
Finally, the investigators used yet another historical cohort as a comparator in a statistical analysis of projected cognitive and functional benefit. Compared with a pooled, placebo-arm, cohort study conducted by the Alzheimer Disease Cooperative Study Group over 12 months, ANAVEX 2-73 would have been associated with 1.8-point bump in score on the MMSE (P less than .016) and a 4-point benefit on the ADCS-ADL (P less than .019).
“The MMSE declined 45% less and the ADCS-ADL declined 56% less than what we would have expected from the historical control data,” Dr. Macfarlane said. “This is not only statistically significant, but clearly clinically meaningful for patients.”
" The P300 wave amplitude showed a small initial bump from about 6 to 7 microvolts by 4 weeks, and then a dip back down to about 6 microvolts until about week 32. Thereafter it steadily improved, landing at around 8 microvolts by 57 weeks – a level usually seen in healthy age-matched controls. There was a significant separation from the P300 decline seen in a matched historical Alzheimer’s cohort, which dropped to about 4 microvolts over a 52-week period while patients were taking donepezil.
The study employed a second historical control group in another cognitive assessment using the Computerized Cogstate Alzheimer’s Battery. All subjects in the large Australian prospective cohort study, called AIBL (Australian Imaging, Biomarkers & Lifestyle Flagship Study of Ageing), were taking standard of care Alzheimer’s drugs. Compared with that cohort, the ANAVEX 2-73 group experienced benefits in processing speed, attention, and working memory, which became statistically significant at week 31 and continued to grow.
At 57 weeks, the mean MMSE score was stable, hovering around the baseline of 20. The ADCS-ADL declined slightly, from a mean of around 70 to around 65.
Finally, the investigators used yet another historical cohort as a comparator in a statistical analysis of projected cognitive and functional benefit. Compared with a pooled, placebo-arm, cohort study conducted by the Alzheimer Disease Cooperative Study Group over 12 months, ANAVEX 2-73 would have been associated with 1.8-point bump in score on the MMSE (P less than .016) and a 4-point benefit on the ADCS-ADL (P less than .019).
“The MMSE declined 45% less and the ADCS-ADL declined 56% less than what we would have expected from the historical control data,” Dr. Macfarlane said. “This is not only statistically significant, but clearly clinically meaningful for patients.”
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