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

Alzheimer Disease, Late Onset Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01773915
• Other study ID #: s54591
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2012
• Last updated: January 13, 2014
• Start date: December 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2013
• Source: Universitaire Ziekenhuizen Leuven
• Contact: Jos Tournoy
• Phone: +3216342640
• Email: jos.tournoy[@]uzleuven.be
• Is FDA regulated: No
• Health authority: Belgium: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

We do not desire to provide a more extensive description

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• mild to moderate AD

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer Disease, Late Onset

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

References & Publications (1)

Gonzales PA, Pisitkun T, Hoffert JD, Tchapyjnikov D, Star RA, Kleta R, Wang NS, Knepper MA. Large-scale proteomics and phosphoproteomics of urinary exosomes. J Am Soc Nephrol. 2009 Feb;20(2):363-79. doi: 10.1681/ASN.2008040406. Epub 2008 Dec 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in blood, saliva and urine protein levels in patients with Alzheimer's Disease versus healthy controls.	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.	Up to 1 year	No