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Status unknownNCT02018913Updated Dec 23, 2013

Blood-brain Barrier Leakage in Dementia. A Dynamic Contrast-enhanced MRI Study

An observational study in Alzheimer's Disease and Vascular Dementia, sponsored by Maastricht University Medical Center. Status unknown. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-12-23.

Sponsored by Maastricht University Medical Center · Observational

The sponsor has not verified this record recently (last verified Dec 2013), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
140
Ages
55 Years and older
Sex
All
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Study summary

Alzheimer's disease (AD) and vascular dementia (VaD) are the most common forms of dementia. Yet, the cause of these diseases is still unknown. A potentially important initiating factor is a disrupted blood-brain barrier. This can initiate cerebral microangiopathy, which has frequently been associated with VaD. Nevertheless, also in most AD patients a substantial increase of vascular damage has been observed. The present study investigates the correlation between blood-brain-barrier breakdown and cognitive decline in AD and VaD. An innovative dynamic contrast-enhanced MRI scan that has recently been developed and tested at our institute, will be used to measure blood-brain barrier permeability.

Objective: We will investigate the relationship between this permeability measure and (i) cognitive performance and (ii) the status of MRI visible cerebrovascular pathology (i.e. white matter hyperintensities, lacunar infarctions, microbleeds) in the most common forms of dementia.

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Conditions studied

  • Alzheimer's Disease
  • Vascular Dementia
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.

This study's planned enrollment of 140 is below the median of 200 across 751 observational studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
55 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

To obtain variation in macrovascular pathology and cognitive outcome measures, patients with AD, VaD, mixed AD and VaD, mild cognitive impairment (due to AD), vascular cognitive impairment and subjective cognitive impairment will be included. The total number of patients is 120, approximately 20 patients per disorder category as mentioned above. The patients will be recruited from the memory clinic of the Maastricht University Medical Center. Also a group of 20 age-matched healthy controls will be included. The total number of participants is thus 140.

Inclusion criteria

Patients:

  • 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:

  • 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.

Exclusion criteria

Exclusion Criteria:

  • Contraindications for 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. If participants have a low renal function as determined by \<30 GFR \<60, the PI will contact a radiologist (Paul Hofman). The radiologist will decide if this patient should be excluded.
  • Major vascular disorders (e.g. stroke, heart disease)
  • Psychiatric or neurological disorders: Major depression (\< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (\< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere's disease; and brain infections.
  • Structural abnormalities of the brain
  • Cognitive impairment due to alcohol/drug abuse or abuse of other substances.
  • Absence of reliable informant (for patient groups)
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
140 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI

    Time frame: Up to 4 years: April 2014-April 2018

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Study locations

No study locations are listed for this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02018913
Lead sponsor
Maastricht University Medical Center
Collaborators
Netherlands Alzheimer Foundation
Responsible party
F.R.J.Verhey (Professor of neuropsychiatry and old age psychiatry, Maastricht University Medical Center) — Principal investigator
First posted
Dec 23, 2013
Start date
Apr 2014
Primary completion
Apr 2018 (estimated)
Completion
Apr 2018 (estimated)
Last update
Dec 23, 2013
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.

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