Alzheimer Disease, Late OnsetNCT01773915
New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
An observational study of Alzheimer Disease, Late Onset, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Late Onset
- How many people
- 20 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2012to Jun 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Persons with Alzheimer's disease
Who may be able to join
- mild to moderate AD
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
UZ Leuven
Leuven
Jos Tournoy, jos.tournoy@uzleuven.be
Jos Tournoy
About this study
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.
Read the detailed description
We do not desire to provide a more extensive description
- Conditions
- Alzheimer Disease, Late Onset
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| AD patients | Subject fulfilling the McKhann criteria for clinical probable AD | |
| Healthy elder persons | Healthy controls with abscence of any cognitive disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionJan 2014
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer Disease, Late OnsetStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof Dr Jos Tournoy, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Bart De Strooper, Principal investigator, KU LeuvenFrancesc Guix, Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01773915
- Sponsor's protocol ID
- s54591
- Status last verified
- Jan 2013
- First submitted
- 26 Dec 2012
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 19056867
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- New Proteins in Body Fluids as Potential Biomarker for Alzheimer's Disease: a Pilot Study
- ClinicalTrials.gov ID
- NCT01773915
- Acronym / sponsor ID
- s54591
- Conditions
- Alzheimer Disease, Late Onset
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jun 2014 (estimated)
- First posted
- 23 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
We do not desire to provide a more extensive description
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AD patients | – | –Subject fulfilling the McKhann criteria for clinical probable AD |
| Healthy elder persons | – | –Healthy controls with abscence of any cognitive disorder |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Persons with Alzheimer's disease
Key inclusion criteria (1 listed)
- mild to moderate AD
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Background: PubMed 19056867Gonzales 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart De Strooper principal investigator
KU Leuven
Francesc Guix principal investigator
KU Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer Disease, Late Onset, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jos Tournoy (+3216342640, jos.tournoy@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in blood, saliva and urine protein levels in patients with Alzheimer's Disease versus healthy controls. (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01773915, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2014; AzTrials last refreshed its copy on 26 Oct 2026.