Blood-brain barrier leakage in dementia A dynamic contrast-enhanced MRI study

Completed

Conditions: neurodegeneratieve aandoeningen
dementia

Registration Number: NL-OMON44871

Lead Sponsor: niversiteit Maastricht

Brief Summary: Trial ended prematurely

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 101

Inclusion Criteria

Patients (baseline):
* Informed consent before participation in the study
* Age of 55 and older
* Diagnosed with AD, VaD, mixed AD and VaD, mild cognitive impairment, vascular cognitive impairment and subjective cognitive impairment
* MMSE * 20 and patients are mentally competent (in general, individuals with an MMSE *18 are considered mentally competent) ;Healthy participants (baseline):
* Informed consent before participation in the study
* Age of 55 and older
* No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment.
* MMSE * 26
* No substantial memory complaints (according to participant)
* Average age, gender and education is similar to the patient groups.;Follow-up participants with leakage:
* Informed consent before participation in the follow-up study
* MMSE * 20
* Participation in baseline study
* Blood-brain barrier leakage is apparent on baseline post-contrast FLAIR sequence ;Follow-up participants without leakage:
* Informed consent before participation in the follow-up study
* MMSE * 20
* Participation in baseline study
* Blood-brain barrier leakage is not apparent on baseline post-contrast FLAIR sequence
* Average age, gender and diagnosis is similar to the follow-up participants with leakage group.

Exclusion Criteria

* Contraindications for MR scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos)
* Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR < 30 mL/min; or known allergy to Gadovist.
* Major vascular disorders (e.g. stroke<3 months ago, unstable heart disease <3 months ago. Because AD and VaD and their preceding stages are associated with both stroke and heart disease (such as myocardial infarction) we will exclude participants when these occurred <3 months before inclusion).
* Psychiatric or neurological disorders: Major depression (< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (< 12 mnd); epilepsy; Parkinson*s disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere*s disease; and brain infections.
* Structural abnormalities of the brain
* Absence of reliable informant (for patient groups)
* cognitive impairment due to alcohol abuse or other substances

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study measures are blood brain barrier permeability as measured by<br /><br>T1-weighted dynamic contrast MRI; and cognitive performance as measured by the<br /><br>neuropsychological assessment of the standard diagnostic procedure of the<br /><br>memory clinic, including global cognition (Mini Mental State examination),<br /><br>memory performance (Verbal Learning Test), mental speed (Letter Digit<br /><br>Substitution Test), and attention (Stroop task and Concept Shifting Test).<br /><br>Another outcome measure is the status of MRI visible cerebrovascular pathology<br /><br>(i.e. white matter hyperintensities, lacunar infarctions, microbleeds).</p><br>

Secondary Outcome Measures