Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment
This is a phase I, an open label, single dose and parallel group study to assess short term pharmacodynamics and safety of GSK933776. The effect on the beta amyloid levels will be assessed in early (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
19
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany
GSK Investigational Site
Tübingen, Baden-Wurttemberg, Germany
GSK Investigational Site
Ulm, Baden-Wurttemberg, Germany
GSK Investigational Site
Munich, Bavaria, Germany
The temporal changes of amyloid beta levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
To compare the changes of amyloid beta levels between the baseline (9 hours) and after single dose of GSK933776 iv administration of 13 hours
Time frame: 22 hours
The temporal changes of total and free amyloid beta levels in plasma after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
Time frame: Two months
The temporal changes of Tau and phosphor Tau - 181 levels in CSF after GSK933776 single dose administration in the patients with Alzheimer's disease and Mild Cognitive impairment
Time frame: 22 hours
Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals.
Time frame: three months
To assess the safety and tolerability after single dose of GSK933776 administration.
The safety and tolerability measures are performed at screening, dosing day and follow up. The assessments included: • Adverse event reporting and safety laboratory data. • CNS Safety: MRI and MMSE. • CVS safety: ECG and vital signs. •Anti-GSK933776 antibodies.
Time frame: three months
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GSK Investigational Site
Aachen, North Rhine-Westphalia, Germany
GSK Investigational Site
Malmo, Sweden
GSK Investigational Site
Stockholm, Sweden