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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01773915
Recruitment Status : Unknown
Verified January 2013 by Prof Dr Jos Tournoy, Universitaire Ziekenhuizen Leuven.
Recruitment status was:  Recruiting
First Posted : January 23, 2013
Last Update Posted : January 14, 2014
Information provided by (Responsible Party):
Prof Dr Jos Tournoy, Universitaire Ziekenhuizen Leuven

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
Alzheimer Disease, Late Onset

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

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Study Type : Observational
Estimated 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 : December 2012
Actual Primary Completion Date : January 2014
Estimated Study Completion Date : June 2014

Resource links provided by the National Library of Medicine

AD patients
Subject fulfilling the McKhann criteria for clinical probable AD
Healthy elder persons
Healthy controls with abscence of any cognitive disorder

Primary Outcome Measures :
  1. Differences in blood, saliva and urine protein levels in patients with Alzheimer's Disease versus healthy controls. [ Time Frame: 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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Persons with Alzheimer's disease

Inclusion Criteria:

- mild to moderate AD

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01773915

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Contact: Jos Tournoy +3216342640

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UZ Leuven Recruiting
Leuven, Belgium
Contact: Jos Tournoy   
Principal Investigator: Jos Tournoy         
Sponsors and Collaborators
Universitaire Ziekenhuizen Leuven
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Principal Investigator: Bart De Strooper KU Leuven
Principal Investigator: Francesc Guix KU Leuven

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Responsible Party: Prof Dr Jos Tournoy, MD PhD, Universitaire Ziekenhuizen Leuven Identifier: NCT01773915    
Other Study ID Numbers: s54591
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2013
Additional relevant MeSH terms:
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Alzheimer Disease
Late Onset Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Disease Attributes
Pathologic Processes