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Dutch Study on CSF and PET Biomarker Concordance


- candidate number15738
- NTR NumberNTR4273
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR21-nov-2013
- Secondary IDsB003 
- Public TitleDutch Study on CSF and PET Biomarker Concordance
- Scientific TitleThe Dutch CSF and PET Biomarker Concordance of Alzheimers Disease pathology study
- ACRONYM
- hypothesisWe aim to assess the concordance of CSF protein measurements and Flutemetamol PET imaging.
- Healt Condition(s) or Problem(s) studiedAlzheimer
- Inclusion criteriaSubjects

- 50 to 85 years of age
- Seen at the memory clinic of the VUmc Alzheimer Center for standardized dementia screening
- who have signed informed consent form
- Exclusion criteriaSubjects who
- are medically unstable
-require additional laboratory tests or workup
- receiving any investigational medications
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 20-nov-2013
- planned closingdate20-nov-2015
- Target number of participants50
- InterventionsA Lumbar puncture is performed per local standard procedures and one Flutemetamol PET scan will be performed within 6 months.
- Primary outcomeTo assess the concordance of [18F]Flutemetamol PET amyloid status across a range of detergent-based CSF tau:A1-42 ratio assay values
- Secondary outcomeTo compare the concordance between [18F]Flutemetamol PET and the detergent-based CSF assay and the well established abeta 1-42, tau and p-tau assays used routinely in VUmc in the same range of patients
- Timepointslumbar puncture and Flutemetamol PET will be performed within 6 months.
- Trial web sitewww.alzheimercentrum.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESProf. MD. PhD. Ph. Scheltens
- CONTACT for SCIENTIFIC QUERIESProf. MD. PhD. Ph. Scheltens
- Sponsor/Initiator VU University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
GE Healthcare, Merck
- PublicationsN/A
- Brief summaryIn the present study, we aim to estimate concordance between different biomarkers developed to interrogate the presence of brain amyloid deposition. A CSF fluid biomarker (tau: A 1-42 ratio, using a novel collection method incorporating detergent for enhanced A recovery) is currently in development. A specific threshold cut-off value of this assay defining patients with relevant amyloid burden has not yet been established. By contrast, [18F]Flutemetamol PET outcomes are based on an already-specified threshold cut-off. The objective of the current study will be to compare [18F]Flutemetamol PET imaging measures of brain amyloid to measurements made using the detergent-based tau:A1-42 ratio assay.
- Main changes (audit trail)
- RECORD21-nov-2013 - 27-mrt-2014


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