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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Prof Dr Jos Tournoy, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:
NCT01773915
First received: December 26, 2012
Last updated: January 13, 2014
Last verified: January 2013
  Purpose
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
Alzheimer Disease, Late Onset

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study

Resource links provided by NLM:


Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:
  • Differences in blood, saliva and urine protein levels in patients with Alzheimer's Disease versus healthy controls. [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.


Biospecimen Retention:   Samples Without DNA
Urine, blood and saliva in Biobank

Estimated Enrollment: 20
Study Start Date: December 2012
Estimated Study Completion Date: June 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
AD patients
Subject fulfilling the McKhann criteria for clinical probable AD
Healthy elder persons
Healthy controls with abscence of any cognitive disorder

Detailed Description:
We do not desire to provide a more extensive description
  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Persons with Alzheimer's disease
Criteria

Inclusion Criteria:

- mild to moderate AD

Exclusion Criteria:

  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: NCT01773915

Locations
Belgium
UZ Leuven
Leuven, Belgium
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
Investigators
Principal Investigator: Bart De Strooper Katholieke Universiteit Leuven
Principal Investigator: Francesc Guix Katholieke Universiteit Leuven
  More Information

Publications:
Responsible Party: Prof Dr Jos Tournoy, MD PhD, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier: NCT01773915     History of Changes
Other Study ID Numbers: s54591 
Study First Received: December 26, 2012
Last Updated: January 13, 2014
Health Authority: Belgium: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Late Onset Disorders
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on December 02, 2016