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
Study complete
Study complete
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
    Primary completion date:
    Not applicable
    Observational study model:
    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
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Aachen, Nordrhein-Westfalen, Germany, 52074
    Status
    Study Complete
    Contact us
    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
    Contact us
    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
    Contact us
    Showing 1 - 6 of 7 Results

    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
    Study complete
    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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