Article A Randomised, Single-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics and Pharmacodynamics of Intravenous Infusion of GSK933776 in Patients with Alzheimer's Disease

What is it and what does it include?  

This phase I interventional study assesses single and repeat doses of GSK933776 (a Beta-amyloid (Aβ) antibody) in patients with Alzheimer's disease. A total of 50 participants ages 55 and older and with a clinical diagnosis of probable Alzheimer's disease were enrolled. The study aims to investigate the safety and tolerability of both single and multiple intravenous administration of GSK933776, and it consists of two parts:  

  • Part A: a single-blind, single dose, placebo controlled, dose escalation study in up to five consecutive cohorts of Alzheimer’s Disease subjects. Each subject receives a single infusion of GSK933776 or placebo. 
  • Part B: a single-blind, repeat dose, placebo-controlled dose escalation design. 

How can I use this dataset to advance my research? 

This dataset is ideal if: 

  • you’re studying the effects of an anti-amyloid β monoclonal antibody on geographic atrophy (GA), secondary to age-related macular degeneration (AMD). 
  • you’re interested in analyzing plasma antibody concentration and levels of free amyloid β in plasma in patients with AD or AMD who received IV infusion of GSK933776. 
  • you’re investigating Abeta peptides as a major therapeutic target for the treatment of Alzheimer’s disease (AD) by means of Abeta antibody administration. 

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

Of course!  

  • AD & Pharmacokinetics: 

In 2015, researchers found no cases of amyloid-related imaging abnormalities, such as edema (ARIA-E) or hemorrhage (ARIA-H), after GSK933776 administration. Three patients across the two studies developed anti-GSK933776 antibodies. In this FTIH (first-time-in-human) study the Fc-inactivated anti-β amyloid (Aβ) monoclonal antibody (mAb) GSK933776 engaged its target in plasma and CSF without causing brain ARIA-E/H in patients with mild AD or MCI. March 2015 – DOI:  10.1371/journal.pone.0098153 

  • AD & Pharmacokinetics: 

In 2015, researchers investigated β and tau levels in cerebrospinal fluid (CSF), and the relationship between Aβ levels and Aβ modulation in plasma was explored. GSK933776 demonstrated pharmacological activity and target engagement in CSF and plasma, and the continuous sampling method via a catheter successfully assessed the Aβ changes following single-dose administration of GSK933776. April 2014 – DOI: 10.1186/alzrt249 

Manuscripts citing this dataset

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