Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient
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Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment
Condition or disease
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.
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 [ Time Frame: 22 hours ]
To compare the changes of amyloid beta levels between the baseline (9 hours) and after single dose of GSK933776 iv administration of 13 hours
Secondary Outcome Measures :
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. [ Time Frame: three months ]
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.
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Ages Eligible for Study:
55 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Probable mild Alzheimer's disease (MMSE 20-26) or mild cognitive impairment
Increase in total tau or p-tau in CSF
Decrease in amyloid beta in CSF
Stable dose of cholinesterase inhibitors, memantine or selegine or no treatment
Body weight less than 120 kg
Willingness to comply with contraceptive methods if self or partner is of child-bearing potential
Any other cause of dementia
Other significant neurologic or psychiatric illness
Hachinski Ischemia Score >4
More than 3 microbleeds on MRI
Type 2 diabetes not controlled by diet
Risk of cerebrovascular disease, cerebral haemorrhage or stroke
History of systemic autoimmune disease
Use of platelet anti-aggregates or anti-coagulants (Aspirin up to 325 mg/day is allowable)
Use of chronic corticosteroids
Uncontrolled hypertension in spite of antihypertensive medications
Renal or hepatic insufficiency or clinically significant anaemia
In nursing home care
Contraindications to lumbar puncture or MRI
Prior participation in therapeutic studies only after adequate wash-out period