Effects on the CIBIC-plus:

Figure 12 is a histogram of the percentage distribution of CIBIC-plus scores attained by patients assigned to each of the two treatment groups who completed 13 weeks of treatment. The mean RAZADYNE^tm-placebo differences for the group of patients in the mean rating of change from baseline were 0.37 units. The mean rating for the 24-32 mg/day group was statistically significantly superior to placebo.

Figure 12: Distribution of CIBIC-plus Ratings at Week 13

Age, Gender and Race:

Patients age, gender, or race did not predict clinical outcome of treatment.

The efficacy of RAZADYNE^tm ER Extended-Release Capsules was studied in a randomized, double-blind, placebo-controlled trial which was 6 months in duration, and had an initial 4-week dose-escalation phase. In this trial, patients were assigned to one of 3 treatment groups: RAZADYNE^tm ER in a flexible dose of 16 to 24 mg once daily; RAZADYNE^tm Tablets in a flexible dose of 8 to 12 mg twice daily; and placebo. The primary efficacy measures in this study were the ADAS-cog and CIBIC-plus. On the protocol-specified primary efficacy analysis at Month 6, a statistically significant improvement favoring RAZADYNE^tm ER over placebo was seen for the ADAS-cog, but not for the CIBIC-plus. RAZADYNE^tm ER showed a statistically significant improvement when compared with placebo on the Alzheimers Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) scale, a measure of function, and a secondary efficacy measure in this study. The effects of both RAZADYNE^tm ER Capsules and RAZADYNE^tm Tablets on the ADAS-cog, CIBIC-plus, and ADCS-ADL were similar in this study.

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