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


Maher-Edwards, Gareth, Dixon, Ruth, Hunter, Jackie, Gold, Michael, Hopton, Gillian, Jacobs, Gemma, Hunter, Jo, Williams, Pauline


International Journal Of Geriatric Psychiatry, Volume: 26, No.: 5, Pages.: 536-544

Year of Publication



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.; Copyright © 2010 John Wiley & Sons, Ltd.

Bibtex Citation

@article{Maher_Edwards_2010, doi = {10.1002/gps.2562}, url = {}, year = 2010, month = {sep}, publisher = {Wiley-Blackwell}, volume = {26}, number = {5}, pages = {536--544}, author = {Gareth Maher-Edwards and Ruth Dixon and Jackie Hunter and Michael Gold and Gillian Hopton and Gemma Jacobs and Jo Hunter and Pauline Williams}, title = {{SB}-742457 and donepezil in Alzheimer disease: a randomized, placebo-controlled study}, journal = {Int J Geriatr Psychiatry} }


aged, aged, 80 and over, alzheimer disease, analysis of variance, cholinesterase inhibitors, cognition, donezepil, drug effects, drug therapy, female, humans, indans, male, middle aged, piperidines, quinolines, sb742457, serotonin antagonists, sulfones, therapeutic use

Countries of Study


Types of Dementia

Alzheimer’s Disease

Types of Study

Randomised Controlled Trial

Type of Outcomes


Type of Interventions

Pharmaceutical Interventions

Pharmaceutical Interventions

Anti-Alzheimer medications, e.g.: donezepil, galantamine, rivastigmine, memantime