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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01424436
First received: August 4, 2011
Last updated: January 27, 2017
Last verified: January 2017
  Purpose
Modulation of beta-amyloid levels in CSF and plasma by GSK933776 in patients with mild Alzheimer's disease or mild cognitive impairment

Condition Intervention Phase
Alzheimer's Disease
Biological: GSK933776
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Other
Official Title: Modulation of Beta-amyloid Levels in CSF and Plasma by GSK933776 in Patients With Mild Alzheimer's Disease or Mild Cognitive Impairment

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]
  • 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 ]
  • Estimated pharmacokinetic parameters of AUC, Cmax and Tmax in CSF and plasma at multiple time points with various intervals. [ Time Frame: three months ]
  • 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.


Enrollment: 19
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GSK933776 1mg/kg
single dose
Biological: GSK933776
1mg/kg dose group
Experimental: GSK933776 0.1 or 3mg/kg
single dose
Biological: GSK933776
3mg/kg dose group
Experimental: GSK933776 3 or 6mg/kg
single dose
Biological: GSK933776
6mg/kg dose group

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

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01424436

Locations
Germany
GSK Investigational Site
Mannheim, Baden-Wuerttemberg, Germany, 68159
GSK Investigational Site
Tuebingen, Baden-Wuerttemberg, Germany, 72076
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89081
GSK Investigational Site
Muenchen, Bayern, Germany, 81675
GSK Investigational Site
Aachen, Nordrhein-Westfalen, Germany, 52074
Sweden
GSK Investigational Site
Malmö, Sweden, SE-212 24
GSK Investigational Site
Stockholm, Sweden, se-141 86
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 113043
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 113043
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 113043
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 113043
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 113043
For additional information about this study please refer to the GSK Clinical Study Register
Annotated Case Report Form  This link exits the ClinicalTrials.gov site
Identifier: 113043
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 113043
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01424436     History of Changes
Other Study ID Numbers: 113043
Study First Received: August 4, 2011
Last Updated: January 27, 2017
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Keywords provided by GlaxoSmithKline:
CSF sampling
Alzheimer's disease
Amyloid beta levels

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2017