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New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study

Sponsor
Universitaire Ziekenhuizen Leuven (Other)
Overall Status
Unknown status
CT.gov ID
NCT01773915
Collaborator
(none)
20
Enrollment
1
Location
18
Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Alzheimer's disease (AD) is the most common neurodegenerative disorder afflicting the elderly. Currently, some biochemical tests performed on Cerebrospinal Fluid (CSF) samples have demonstrated to discriminate to some extend between AD and non-AD individuals based on the levels of tau, phospho-tau or Aβ42. We aim to investigate newly identified proteins whose levels increase during the Braak Stages of AD that are accessible in other body fluids such as blood, urine or saliva. The detection of these proteins would allow performing simple tests in case its levels were confirmed to be associated with the AD pathology.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    We do not desire to provide a more extensive description

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    20 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
    Study Start Date :
    Dec 1, 2012
    Actual Primary Completion Date :
    Jan 1, 2014
    Anticipated Study Completion Date :
    Jun 1, 2014

    Arms and Interventions

    Arm Intervention/Treatment
    AD patients

    Subject fulfilling the McKhann criteria for clinical probable AD
    Healthy elder persons

    Healthy controls with abscence of any cognitive disorder

    Outcome Measures

    Primary Outcome Measures

    1. Differences in blood, saliva and urine protein levels in patients with Alzheimer's Disease versus healthy controls. [Up to 1 year]

      Protein levels will be measured by classical immunoblotting blot analysis and quantified; Classical statistical analyses will be performed in order to detect any significant differences.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • mild to moderate AD
    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 UZ Leuven Leuven Belgium

    Sponsors and Collaborators

    • Universitaire Ziekenhuizen Leuven

    Investigators

    • Principal Investigator: Bart De Strooper, KU Leuven
    • Principal Investigator: Francesc Guix, KU Leuven

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Prof Dr Jos Tournoy, MD PhD, Universitaire Ziekenhuizen Leuven
    ClinicalTrials.gov Identifier:
    NCT01773915
    Other Study ID Numbers:
    • s54591
    First Posted:
    Jan 23, 2013
    Last Update Posted:
    Jan 14, 2014
    Last Verified:
    Jan 1, 2013
    Additional relevant MeSH terms:
    Alzheimer Disease
    Late Onset Disorders

    Study Results

    No Results Posted as of Jan 14, 2014