Study of SB-742457 or Donepezil Versus Placebo in Subjects With Mild-to-moderate Alzheimer's Disease

Summary

The study is designed to investigate the efficacy, safety and tolerability of SB-742457 versus placebo in subjects with mild-to-moderate Alzheimer's disease. SB-742457 is an experimental treatment which increases the levels of certain chemicals in the brain that are often decreased in patients with Alzheimer's disease.

Timeline

Start

2008-07-04

Primary completion

2010-03-01

Completion

2010-03-09

Outcome

Missed primary endpoint

paper Study 1: SB742457 monotherapy was not statistically significantly different from placebo on any endpoint. PMID 29854923 ↗

registry Placebo vs SB-742457-15mg; p = 0.159; Mean Difference (Net) 1.1 (95% CI -0.4 to 2.7) NCT00708552 ↗

registry Placebo vs SB-742457-35mg; p = 0.410; Mean Difference (Net) 0.7 (95% CI -0.9 to 2.3) NCT00708552 ↗

registry Placebo vs SB-742457-35mg; p = 0.394; Mean Difference (Net) -0.1 (95% CI -0.4 to 0.2) NCT00708552 ↗

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
Comparator	Donepezil	Small molecule	5 mg	—
Comparator	Donepezil	Small molecule	10 mg	—
Subject	intepirdine	Small molecule	15 mg	—
Subject	intepirdine	Small molecule	35 mg	—

Indications