Cerebral amyloid angiopathy fluid biomarkers evaluation - Alzheimer*s Disease (CAFÉ-AD)
- Conditions
- ziekte van AlzheimerCerebral amyloid angiopathysmall vessel disease10007963
- Registration Number
- NL-OMON48320
- Lead Sponsor
- Radboud Universitair Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 50
Diagnosis of Alzheimer*s disease made according to recent clinical criteria (26)
- Subjects are mentally competent to take a decision on participation.
- Written informed consent
- Age >55 years
- CDR 0.5 or 1.0
Evidence of recent (< 3 months prior to planned lumbar puncture) neurological
diseases other than Alzheimer*s disease (e.g. brain tumors, other vascular
conditions (e.g. malformations), inflammatory or infectious disease)
- Evidence of recent (< 3 months prior to planned lumbar puncture) ischemic or
hemorrhagic stroke
- Presence of blood coagulopathy, established by medical history
- Allergy to local anesthetic agents
- Contra-indication for lumbar puncture: medical history of compression of
spinal cord, spinal surgery, skin infection, developmental abnormalities in
lower spine
- Subjects who are currently participating in another study or have
participated in a clinical study within the previous 30 days, based on their
own report
- Subjects with a recent history of drug abuse
- Subjects who are part of the study staff personnel or family members of the
study staff personnel
- Intracranial clips
- Contra-indications to MR Imaging:
o Claustrophobia
o Pacemakers and defibrillators
o Nerve stimulators
o Intraorbital or intraocular metallic fragments
o Cochlear implants
o Ferromagnetic implants
o Hydrocephalus pump
o Some intra-uterine device
o An iron wire behind the teeth placed before 1995
o Permanent make-up
o Tattoos above the shoulders
o Severe physical restriction / inability to be scanned, such as weight above
120 kg
o Difficulty with lying down for 45 minutes
o Light-sensitive epilepsy
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Biomarkers will first be evaluated for their suitability to serve as biomarkers<br /><br>by univariate testing (t-test in case of comparison of two groups) or ANOVA<br /><br>(comparison of more than two groups). Main comparisons will be between AD<br /><br>patients with radiological evidence of CAA and Controls (recruited via the CAFÉ<br /><br>project, file number 2017-3605) and between AD patients with radiological<br /><br>evidence of CAA versus AD patients without radiological evidence of CAA.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Establishing correlations between the new neurochemical biomarkers on the one<br /><br>hand and neuroimaging and neuropsychological<br /><br>biomarkers on the other.</p><br>