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Completed

NCT Number: NCT01424436

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

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

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

GSK Investigational Site, Mannheim, Baden-Wurttemberg, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

GSK933776

Biological

1mg/kg dose group

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

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

    Time frame: three months

  4. 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.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Modulation of Beta-amyloid Levels in CSF and Plasma by GSK933776 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 29, 2011
Registry last updated
Jun 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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