Article A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of the H3 Receptor Antagonist, GSK239512 in Subjects With Mild to Moderate Alzheimer's Disease

What is it and what does it include? 

This study aims to evaluate the cognitive enhancing effects and tolerability of GSK239512 compared to placebo in patients with mild to moderate Alzheimer's. This is a 16-week, Phase II, multi-centre, randomised, double-blind, placebo-controlled, parallel group design study in 146 subjects 50 years or older with mild to moderate AD. The study collected patient’s data from 34 centers in 8 countries (Bulgaria, Chile, Czech Republic, Germany, Korea, Russia, Slovakia and UK). Participants received GSK239512 or placebo before randomization, and a weekly review of safety, tolerability, and cognitive performance measures.  

GSK239512 is a highly potent, selective, orally bioavailable and brain-penetrant histamine H3 receptor antagonist. It is believed that it has the potential to improve cognition in patients with Alzheimer’s disease (AD). 

How can I use this dataset to advance my research? 

This dataset is ideal if: 

  • you’re investigating the effects GSK239512 and placebo on episodic memory in patients with mild to moderate AD or other cognitive domains. 
  • you’re studying the changes in cerebrospinal fluid (CSF) Abeta1–42 levels in patients with AD taking Abeta antibodies. 
  • you’re interested in studying changes in executive function, working memory, and episodic memory in patients with a diagnosis of mild to moderate AD who are undergoing Abeta antibody treatment and/or placebo. 

Has this dataset helped researchers understand Alzheimer’s and other dementias better? 

Of course!  

  • AD & Pharmacokinetics:  

In 2014, researchers showed improved episodic memory in patients with mild to moderate AD GSK239512, at doses up to 80µg/day. However, no improvements were observed in executive function/working memory or other domains of cognition. No changes were observed on any of the clinical measures included as secondary endpoints (including ADAS-Cog) indicating that GSK239512 failed to show benefit in this population. GSK239512 had an acceptable safety and tolerability profile. These findings suggest that H3 antagonists may, at most, have modest and selective effects on cognitive function in patients with mild-to-moderate AD. 2014 – DOI:  10.2174/1567205010666131212110148 

Manuscripts citing this dataset 

  • A randomized, double-blind, placebo-controlled, 16-week study of the H3 receptor antagonist, GSK239512 as a monotherapy in subjects with mild-to-moderate Alzheimer's disease. 2014. DOI: 10.2174/1567205010666131212110148 

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