A study to investigate the safety and tolerability of both single and multiple intravenous administration of GSK933776 in patients with Alzheimer's Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
Part A planned doses cohort 1 to cohort 3 0.001 mg/kg, 0.01 mg/kg and 0.1 mg/kg. Part B planned doses cohort 4 to cohort 7 0.1 mg/kg, 1mg/kg, 3mg/kg and 10 mg/kg
Part A first 2 cohorts 5 patients per cohort 2 placebo and 3 active third cohort part A 2 placebo 6 active. Part B 8 patients per cohort 2 placebo 6 active.
GSK Investigational Site
Herston, Queensland, Australia
GSK Investigational Site
Heidelberg Heights, Victoria, Australia
GSK Investigational Site
Fremantle, Western Australia, Australia
GSK Investigational Site
Lørenskog, Norway
Adverse events. Changes suggesting potential adverse events detected in the physical & neurological examination, brain MRI, cognitive status, laboratory parameters, ECG & vital signs.
Time frame: 12 weeks for Part A; 34 weeks in Part B
Plasma pharmacokinetic parameters of GSK933776. Pharmacodynamic effects of GSK 933776. CSF detectable levels of GSK933776. Effects of GSK933776 on plasma and CSF biomarkers. Titre & neutralising activity of anti-GSK933776 antibodies. Exploratory PET scan
Time frame: 12 weeks for Part A; 34 weeks in Part B
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GSK Investigational Site
Malmö, Sweden
GSK Investigational Site
Mölndal, Sweden
GSK Investigational Site
Stockholm, Sweden