La validez convergente fue medida al comparar el rendimiento del GDS respecto al MMSE, CDR y ADCS-ADL
However, compared with those on placebo, those taking 1,600 mg/day had significant slowing of decline in all three outcome measures: 44% less decline on the ADCS-ADL
, 38% less decline on the CDR, and 61% less decline on the ADAS-cog.
After 28 weeks in the monotherapy trial, the mean difference in ADCS-ADL
scores between patients treated with memantine and those on placebo was 3.
Schneider, professor of psychiatry, neurology, and gerontology at the University of Southern California Keck School of Medicine, Los Angeles, described a 1-point difference in the ADCS-ADL
score as the "difference between someone not being able to do a particular activity and being able to do it with help," and a Z-point difference as being able to do it independently.
But the mean change from baseline among those on donepezil was lower: The mean difference in scores of donepezil, compared with placebo in ADCS-ADL
severe, was 1.
Those in the 800-mg group showed an effect size of 45% at 12 months, as measured by the ADCS-ADL
, though this did not reach statistical significance.
The ability of Phenserine to improve memory and cognition will be measured by the standard ADAS-cog and CIBIC-plus efficacy endpoints, which are recommended by the FDA as well as the ADCS-ADL
to meet European regulatory requirements.