Modulation of Abeta Levels by GSK933776 in Alzheimer's Disease Patient

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 1

Conditions: Alzheimer's Disease

Treatments: Biological: GSK933776

Study type: Interventional

Funder types: Industry

Identifiers

NCT01424436

113043

Details and patient eligibility

About

Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment

Full 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 (MCI) and mild Alzheimer's disease (AD) patients after a single dose of GSK933776 by i.v. administration.

Enrollment: 19 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

GSK933776 1mg/kg

Experimental group

Description:

single dose

Treatment:

Biological: GSK933776

Biological: GSK933776

Biological: GSK933776

GSK933776 0.1 or 3mg/kg

Experimental group

Description:

single dose

Treatment:

Biological: GSK933776

Biological: GSK933776

Biological: GSK933776

GSK933776 3 or 6mg/kg

Experimental group

Description:

single dose

Treatment:

Biological: GSK933776

Biological: GSK933776

Biological: GSK933776