SB-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study

✍ Scribed by Gareth Maher-Edwards; Ruth Dixon; Jackie Hunter; Michael Gold; Gillian Hopton; Gemma Jacobs; Jo Hunter; Pauline Williams

• Publisher: John Wiley and Sons
• Year: 2010
• Tongue: English
• Weight: 199 KB
• Volume: 26
• Category: Article
• ISSN: 0885-6230
• DOI: 10.1002/gps.2562

✦ Synopsis

Objective:

To estimate the treatment effects of sb-742457 and donepezil in alzheimer disease (ad) in a contemporary clinical trial.

Method:

Randomized, controlled, parallel-group, exploratory study with a 4-week, single-blind, placebo run-in phase and 24-week, double-blind treatment phase. primary endpoints were clinician's interview-based impression of change with caregiver input (cibic+) and the alzheimer's disease assessment scale-cognitive subscale (adas-cog).

Results:

One hundred ninety eight subjects with mild-to-moderate probable ad (mmse scores 12-26) were randomized; 196 were included in the intent-to-treat population (placebo, n = 61; sb-742457 35 mg/day, n = 68; donepezil 10 mg/day, n = 67), and 161 completed. drug-placebo treatment differences in cibic+ score at week 24 were -0.17 (90% confidence interval [ci]: -0.50, 0.16) for sb-742457 and -0.28 (90% ci: -0.61, 0.05) for donepezil. drug-placebo treatment differences (90% ci) in change from baseline adas-cog score at week 24 were -0.4 (-2.2, 1.4) for sb-742457 and -1.2 (-3.0, 0.6) for donepezil. all treatments were generally safe and well tolerated.

Conclusions:

In this exploratory study, sb-742457 and donepezil were associated with improvements in global function. treatment effect on cognition for both sb-742457 and donepezil was smaller than those previously observed in previous clinical studies with donepezil.