Blood-brain Barrier Permeability in Alzheimer's Disease
NCT ID: NCT01574456
Last Updated: 2013-12-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
39 participants
OBSERVATIONAL
2012-03-31
2013-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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7 patients diagnosed with dementia of the Alzheimer's type
No interventions assigned to this group
13 patients with mild cognitive impairment
No interventions assigned to this group
19 healthy controls
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 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)
ALL
Yes
Sponsors
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Maastricht University Medical Center
OTHER
Responsible Party
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Locations
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Leids University Medical Center
Leiden, , Netherlands
Maastricht University Hospital
Maastricht, , Netherlands
Countries
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Other Identifiers
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NL36156.068.11
Identifier Type: -
Identifier Source: org_study_id