- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01773915
New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
January 13, 2014 updated by: Prof Dr Jos Tournoy, Universitaire Ziekenhuizen KU Leuven
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.
Study Overview
Status
Unknown
Conditions
Detailed Description
We do not desire to provide a more extensive description
Study Type
Observational
Enrollment (Anticipated)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jos Tournoy
- Phone Number: +3216342640
- Email: jos.tournoy@uzleuven.be
Study Locations
-
-
-
Leuven, Belgium
- Recruiting
- UZ Leuven
-
Contact:
- Jos Tournoy
- Email: jos.tournoy@uzleuven.be
-
Principal Investigator:
- Jos Tournoy
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Persons with Alzheimer's disease
Description
Inclusion Criteria:
- mild to moderate AD
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
AD patients
Subject fulfilling the McKhann criteria for clinical probable AD
|
Healthy elder persons
Healthy controls with abscence of any cognitive disorder
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Bart De Strooper, KU Leuven
- Principal Investigator: Francesc Guix, KU Leuven
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
December 1, 2012
Primary Completion (Actual)
January 1, 2014
Study Completion (Anticipated)
June 1, 2014
Study Registration Dates
First Submitted
December 26, 2012
First Submitted That Met QC Criteria
January 18, 2013
First Posted (Estimate)
January 23, 2013
Study Record Updates
Last Update Posted (Estimate)
January 14, 2014
Last Update Submitted That Met QC Criteria
January 13, 2014
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- s54591
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer Disease, Late Onset
-
ProgenaBiomeRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer Disease 1 | Alzheimer Disease 2 | Alzheimer Disease 3 | Alzheimer Disease 4 | Alzheimer Disease 7 | Alzheimer Disease 17 | Alzheimer Disease 5 | Alzheimer Disease 6 | Alzheimer Disease 8 | Alzheimer Disease 10 | Alzheimer... and other conditionsUnited States
-
Indiana UniversityNational Institute on Aging (NIA)RecruitingDementia | Alzheimer Disease, Late OnsetUnited States
-
University of MiamiColumbia University; National Institute on Aging (NIA); Case Western Reserve... and other collaboratorsRecruitingDementia | Mild Cognitive Impairment | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Dementia of Alzheimer TypeUnited States
-
Massachusetts Institute of TechnologyRecruitingAlzheimer Disease | Alzheimer Disease, Early Onset | Alzheimer Disease, Late Onset | Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Alzheimer'sUnited States
-
Ohio State UniversityCompletedAlzheimer Disease, Late OnsetUnited States
-
NeuroEM Therapeutics, Inc.University of South Florida Health / Byrd Alzheimer's InstituteUnknownAlzheimer Disease | Alzheimer Disease, Late OnsetUnited States
-
NeuroEM Therapeutics, Inc.Invicro, Boston; Byrd Alzheimer's Institute, University of South Florida; University... and other collaboratorsCompletedAlzheimer Disease | Alzheimer Disease, Late OnsetUnited States
-
Federal University of Minas GeraisCompletedAlzheimer Disease, Late Onset
-
Tamir Ben-HurHebrew University of JerusalemEnrolling by invitationAlzheimer Disease, Late OnsetIsrael
-
IRCCS Centro San Giovanni di Dio FatebenefratelliI.R.C.C.S. Fondazione Santa Lucia; Ministero della Salute, ItalyRecruitingAlzheimer Disease | Alzheimer Disease, Late Onset | Cognitive DeteriorationItaly