Blood-brain Barrier Permeability in Alzheimer's Disease

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Sex eligibility

All sexes

Study type

Observational

Primary location

Leids University Medical Center, Leiden, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI

Time frame: 22 months

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Registry information

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2013
First posted: Apr 10, 2012
Registry last updated: Dec 10, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed