A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease

Summary

The study is designed to investigate the safety and efficacy of SB-742457 when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease.

Timeline

Start

2008-07-01

Primary completion

2010-05-21

Completion

2010-11-16

Outcome

Mixed primary results

registry analysis (superiority or other test); Donepezil + Placebo vs Donepezil + SB-742457 35 mg; p = 0.012; Mean Difference (Net) -1.5 (95% CI -2.7 to -0.3); MMRM NCT00710684 ↗

registry analysis (superiority or other test); Donepezil + Placebo vs Donepezil + SB-742457 35 mg; p = 0.462; Mean Difference (Net) -0.1 (95% CI -0.5 to 0.2); MMRM NCT00710684 ↗

Publications

• Maher-Edwards G, Watson C, Ascher J, Barnett C, Boswell D, Davies J, Fernandez M, Kurz A, Zanetti O, Safirstein B, Schronen JP, Zvartau-Hind M, Gold M. Two randomized controlled trials of SB742457 in mild-to-moderate Alzheimer's disease. Alzheimers Dement (N Y). 2015 May 7;1(1):23-36. doi: 10.1016/j.trci.2015.04.001. eCollection 2015 Jun.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	intepirdine	Small molecule	15 mg	—
Subject	intepirdine	Small molecule	35 mg	—
Background	Donepezil	Small molecule	5 mg	—
Background	Donepezil	Small molecule	10 mg	—

Indications