New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
1 other identifier
observational
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 26, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedJanuary 14, 2014
January 1, 2013
1.1 years
December 26, 2012
January 13, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
AD patients
Subject fulfilling the McKhann criteria for clinical probable AD
Healthy elder persons
Healthy controls with abscence of any cognitive disorder
Eligibility Criteria
Persons with Alzheimer's disease
You may qualify if:
- \- mild to moderate AD
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UZ Leuven
Leuven, Belgium
Related 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.
PMID: 19056867BACKGROUND
Biospecimen
Urine, blood and saliva in Biobank
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bart De Strooper
KU Leuven
- PRINCIPAL INVESTIGATOR
Francesc Guix
KU Leuven
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
December 26, 2012
First Posted
January 23, 2013
Study Start
December 1, 2012
Primary Completion
January 1, 2014
Study Completion
June 1, 2014
Last Updated
January 14, 2014
Record last verified: 2013-01