search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Blood-brain barrier function: The key to successful cognitive aging?


- candidate number26951
- NTR NumberNTR6542
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR24-mrt-2017
- Secondary IDsNL54944.068.16 METC azM/UM
- Public TitleBlood-brain barrier function: The key to successful cognitive aging?
- Scientific TitleBlood-brain barrier function: The key to successful cognitive aging?
- ACRONYMMAAS BBB
- hypothesisBlood-brain barrier leakage is associated with cognitive decline and brain abnormalities during aging.
- Healt Condition(s) or Problem(s) studiedCognitive aging, Inflammation of peri-implant tissues, Blood brain barrier leakage, Blood brain barrier function
- Inclusion criteria• Informed consent before participation
• Participation in 12-year follow-up of MAAS
• MMSE score ≥ 25
• DAD score > 90%
- Exclusion criteria• Contraindications for scanning (e.g. brain surgery; cardiac pacemaker; metal implants; claustrophobia; large body tattoos)
• Contraindications for the gadolinium-containing contrast agent (renal failure) as determined by the eGFR < 30 mL/min
• Diagnosis of dementia, prodromal dementia or MCI (in case of doubt, prof. dr. Frans R.J. Verhey will determine whether the participant may be included)
• Diagnosis of other psychiatric or neurological disorders (major depression (< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (< 12 months); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's Disease; Multiple Sclerosis; brain surgery; brain trauma; past electroshock therapy; kidney dialysis; Meniθre's Disease; brain infections)
• Structural brain abnormalities, as is thus far known from the medical history or will later become evident on the scan.
• Cognitive impairment due to alcohol/drug abuse or abuse of other substances
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 18-apr-2017
- planned closingdate22-dec-2018
- Target number of participants61
- InterventionsParticipants will be subjected to blood sampling, neuropsychological assessment (approximately 60 minutes with five cognitive tests) and MRI scanning (approximately 60 minutes).
- Primary outcome• Episodic memory
• Hippocampal volume
• Blood-brain barrier leakage
- Secondary outcome• Learning
• Basic processing speed
• Complex information processing inhibition
• Global cognition
• Cortical thickness
• WMHs
• Small cortical infarcts
• Lacunes
• Microbleeds
• Enlarged perivascular spaces
• White matter integrity
- TimepointsTwo sessions with one week between sessions
- Trial web sitehttp://breinweb.nl/maas/deelnemers.html#scanstudie
- statusplanned
- CONTACT FOR PUBLIC QUERIESPhD candidate Inge Verheggen
- CONTACT for SCIENTIFIC QUERIESPhD candidate Inge Verheggen
- Sponsor/Initiator Maastricht University
- Funding
(Source(s) of Monetary or Material Support)
NWO - Research Talent Grant, Maastricht University
- Publications
- Brief summaryThe brain is vulnerable to age-related pathologies, which can result in cognitive decline. Nevertheless, some people age successfully, while others suffer substantially from this cognitive decline. To date, the exact mechanism of cognitive aging remains unclear. A potential initiating mechanism is Blood-Brain Barrier (BBB) breakdown. BBB breakdown can cause a suboptimal environment for neuronal cells and results in several pathological changes, which may eventually lead to neuronal damage and cognitive decline. Most techniques to detect BBB breakdown are not sensitive enough to detect the subtle leakage that characterizes normal aging, so that previous BBB studies did not focus on normal cognitive aging. A promising method to detect subtle BBB leakage in vivo in humans is Dynamic Contrast-Enhanced (DCE) Magnetic Resonance Imaging (MRI). Recently, we developed a new DCE MRI scan sequence, making our DCE MRI scan sensitive enough to detect subtle globally distributed leakage spots. We will use this innovative DCE MRI scan in a successfully aging sample. We have been allowed access to the MAastricht Aging Study (MAAS) database to collect our sample, which provides the unique opportunity of having a sample with cognitive pre-measurements already conducted from 1993 to 2005. We will use this information to investigate the association between BBB leakage and cognitive decline over the past 23 years and the association between BBB leakage and radiologically visible brain tissue abnormalities.
- Main changes (audit trail)
- RECORD24-mrt-2017 - 30-jul-2017


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl