Completed

Blood-brain Barrier Permeability in Alzheimer's Disease

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

Alzheimer Disease+6

+ Mental Disorders

+ Brain Diseases

See all eligibility criteria
How is the trial designed

Case-Control

Comparing exposures between individuals with and without disease in order to identify potential risk factors.
Observational
Study Start: March 2012
See protocol details

Summary

Principal SponsorMaastricht University Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 2012

Actual date on which the first participant was enrolled.

The main aim of the present study is to improve our understanding of the role of blood-brain barrier function in dementia of the Alzheimer's type. The investigators hypothesize that microvascular dysfunction - more specifically "cerebral perfusion and blood-brain barrier leakage" - is a determinant of cognitive decline and cortical atrophy in Alzheimer's disease.

Official TitleBlood-brain Barrier Permeability in Alzheimer's Disease
NCT01574456
Principal SponsorMaastricht University Medical Center
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

39 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Case-Control

These studies compare people who have a disease (cases) with those who don't (controls). The goal is to look back at previous exposures or risk factors to identify what might have contributed to the disease.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Alzheimer DiseaseMental DisordersBrain DiseasesCentral Nervous System DiseasesDementiaNervous System DiseasesNeurodegenerative DiseasesNeurocognitive DisordersTauopathies

Criteria

Inclusion Criteria: Patients with AD: * Informed consent before participation in the study * Received standard diagnostic procedure according to the Parelsnoer Initiative procedure * Diagnosed with dementia of the Alzheimer's type * Clinical dementia rating (CDR) of 1, which means a mild to moderate stage of dementia * MMSE ≥ 20 and patients are mentally competent (in general, individuals with an MMSE ≥ 18 are considered mentally competent) Patients with prodromal AD: * Informed consent before participation in the study * Received standard diagnostic procedure according to the Parelsnoer Initiative procedure * Diagnosis of prodromal dementia according to the Dubois criteria (16) * CDR of 0.5, which suggests a very mild stage of dementia * Memory impairment defined as Delayed Recall on Verbal Learning Test (15 WLT) \< 1.5 SD * MMSE ≥ 20 and patients are mentally competent. * Medial temporal lobe atrophy scale MTA ≥ 1 (17) OR abnormal levels of Aß42, t-tau or p-tau Healthy participants: * Informed consent before participation in the study * No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment. * MMSE ≥ 26 * No substantial memory complaints (according to participant) * Age, gender and education is matched to the patient groups. 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. * 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 * Absence of reliable informant (for patient groups)

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Study Objectives

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Suspended

Leids University Medical Center

Leiden, NetherlandsOpen Leids University Medical Center in Google Maps
Suspended

Maastricht University Hospital

Maastricht, Netherlands
Completed2 Study Centers