Status:
COMPLETED
Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient
Lead Sponsor:
GlaxoSmithKline
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-85 years
Phase:
PHASE1
Brief Summary
Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment
Detailed Description
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 (M...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
May 19 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT01424436
Start Date
May 19 2010
End Date
December 8 2011
Last Update
June 14 2017
Active Locations (7)
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1
GSK Investigational Site
Mannheim, Baden-Wurttemberg, Germany, 68159
2
GSK Investigational Site
Tübingen, Baden-Wurttemberg, Germany, 72076
3
GSK Investigational Site
Ulm, Baden-Wurttemberg, Germany, 89081
4
GSK Investigational Site
Munich, Bavaria, Germany, 81675