Blood-brain Barrier Permeability in Alzheimer's Disease
Data Collection
Collected from today forward - ProspectiveAlzheimer Disease+6
+ Mental Disorders
+ Brain Diseases
Case-Control
Comparing exposures between individuals with and without disease in order to identify potential risk factors.Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.39 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-Control
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
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
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
Leids University Medical Center
Leiden, NetherlandsOpen Leids University Medical Center in Google MapsMaastricht University Hospital
Maastricht, Netherlands