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Blood-brain Barrier Leakage in Dementia. A Dynamic Contrast-enhanced MRI Study | Clinical Trials | Clareo Health

UNKNOWN

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

NCT02018913•Maastricht University Medical Center

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.

Eligibility

Age

55 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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
+2 more 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)

Key Dates

Start Date

April 1, 2014

Primary Completion Date

April 1, 2018

Completion Date

April 1, 2018

Last Updated

December 23, 2013

Enrollment

140

ESTIMATED participants

Conditions

Alzheimer's DiseaseVascular Dementia

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 23, 2013Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia