Wednesday, March 24, 2021 9:55:43 PM
The Neuropharmacology publication noted that in the clinical study, 57 weeks of oral once daily ANAVEX®2-73 treatment showed patients improved cognition scores by +2.0 points on MMSE, a 9% mean improvement from baseline to 57 weeks, corresponding to a calculated ADAS-Cog score change of -3.4 (improvement). In these same patients ANAVEX®2-73 also improved ADCS-ADL, by +4.9 points, a 7% mean improvement from baseline to 57 weeks.
An extension of the published study (ANAVEX2-73-003) demonstrated that for the same patients at week 70 MMSE scores improved by +3.0, a 14% improvement from baseline, corresponding to a calculated ADAS-Cog score change of -5.1 (improvement). In these same patients, ANAVEX®2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks. The mean MMSE and ADCS-ADL baseline scores for these patients in this study were 22.3 and 71.1, respectively.[4],[5]
This data seems to be consistent with the effect of ANAVEX®2-73 on cognition assessed in the recently completed placebo-controlled Phase 2 study of 132 patients with Parkinson’s disease dementia (ANAVEX2-73-PDD-001) with once-daily administration of oral 30 mg ANAVEX®2-73, 50 mg ANAVEX®2-73 and placebo for 14 weeks. The observed statistically significant improvement of CDR system Episodic Memory of +42.22 between 50 mg ANAVEX®2-73 and placebo was also dose-dependent (p = 0.003).[6] CDR system Episodic Memory has been shown to be highly correlated (70%) with the ADAS-Cog score (r = 0.7).[7]
The calculated corresponding ADAS-Cog mean change from baseline score is -1.9 (improvement) for patients in the 50 mg dose group, an 8% mean improvement from baseline to 14 weeks. The difference between the ANAVEX®2-73 group and the placebo group in the change from baseline at 14 weeks was a 4.0-point improvement of calculated corresponding ADAS-Cog score (p = 0.015).
The Mini-Mental State Exam (MMSE) and the ADAS-Cog (Alzheimer’s Disease Assessment Scale–Cognitive Subscale) are standard tests for assessing changes in cognition in Alzheimer’s disease trials and known to correlate to a high degree.[8] The ADCS-ADL (Alzheimer’s Disease Cooperative Study–Activities of Daily Living), assesses the competence of patients with Alzheimer’s disease in basic and instrumental function or activities of daily living.“
https://www.anavex.com/anavex-life-sciences-reports-anavex2-73-blarcamesine-featured-as-a-disease-modifying-small-molecule-in-phase-3-clinical-trials-in-a-new-publication-in-medical-journal-titled-future-av/
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