Last updated: 11/07/2018 05:33:12

Modulation of Abeta levels by GSK933776 in Alzheimer’s disease patient

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GSK study ID
113043
See study documents
Clinicaltrials.gov ID
NCT01424436
EudraCT ID
2009-011463-37
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer’s disease or mild cognitive impairment
Trial description: Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer’s disease or mild cognitive impairment
Primary purpose:
Other
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:

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

Timeframe: 22 hours

Secondary outcomes:

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

Timeframe: 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

Timeframe: 22 hours

Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals.

Timeframe: three months

To assess the safety and tolerability after single dose of GSK933776 administration.

Timeframe: three months

Interventions:
Biological/vaccine: GSK933776
Enrollment:
19
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Alzheimer's Disease
Product
GSK933776
Collaborators
GSK
Study date(s)
May 2010 to December 2011
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
55 - 85 years
Accepts healthy volunteers
No
  • Probable mild Alzheimer’s disease (MMSE 20-26) or mild cognitive impairment
  • Increase in total tau or p-tau in CSF
  • Any other cause of dementia
  • Other significant neurologic or psychiatric illness
Inclusion and exclusion criteria
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 location(s)

Location
Status
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Location
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Status
Study Complete
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Location
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68159
Status
Terminated/Withdrawn
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Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
Status
Study Complete
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Location
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
Status
Study Complete
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Location
GSK Investigational Site
MALMÖ, Sweden, SE-212 24
Status
Study Complete
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Location
GSK Investigational Site
STOCKHOLM, Sweden, se-141 86
Status
Study Complete
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Location
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
Status
Terminated/Withdrawn
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)
Protocol
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-08-12

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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