Our main objective is to develop and validate body fluid biomarkers that detect CAA in Alzheimer*s Disease patients during life.
ID
Source
Brief title
Condition
- Other condition
- Central nervous system vascular disorders
Synonym
Health condition
ziekte van Alzheimer
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Biomarkers will first be evaluated for their suitability to serve as biomarkers
by univariate testing (t-test in case of comparison of two groups) or ANOVA
(comparison of more than two groups). Main comparisons will be between AD
patients with radiological evidence of CAA and Controls (recruited via the CAFÉ
project, file number 2017-3605) and between AD patients with radiological
evidence of CAA versus AD patients without radiological evidence of CAA.
Secondary outcome
Establishing correlations between the new neurochemical biomarkers on the one
hand and neuroimaging and neuropsychological
biomarkers on the other.
Background summary
Cerebral amyloid angiopathy (CAA), or the accumulation of amyloid beta protein
(AbP) in the vasculature of the brain, is
increasingly recognized as a factor that contributes significantly to cognitive
decline and higher dementia
Age. Biomarkers that can detect CAA during life are insufficiently available
(only micro bleeding as very late
manifestation of CAA can be seen on MRI), and this contribution of CAA to
cognitive decline and dementia can
have not been available so far.
Study objective
Our main objective is to develop and validate body fluid biomarkers that detect
CAA in Alzheimer*s Disease patients during life.
Study design
Cohort study: identification and full validation of new neurochemical
biomarkers in brain fluid (and blood)
Study burden and risks
Patients are asked to undergo an epidural, MRI and neuropsychological
examination. For the epidural, people are asked to lie on their side with their
legs pulled up. Next, with a thin needle in the lower back, the doctor will
puncture the pouch where the brain fluid is. There is no spinal cord on the
underside of the back, so there is no chance that it will be damaged. An
epidural may cause headache symptoms in some people. These complaints usually
disappear when you lie down. However, a small percentage of people can suffer
for a few days. For younger people this can occur in 15-2% of the cases; in the
elderly it is seen much less (<2%). The occurrence of serious consequences such
as an infection or bleeding after an epidural is only extremely rare (<0.1%).
MRI is a technique for creating images of the body using a very strong magnet
and radio waves.
The MRI consists of a tube of 1.5 m long with a diameter of 70 cm. This tube is
open on both sides and illuminated on the inside. When examining the head, the
patient is only partially in the MRl. The patient can talk to the lab
technician and he can also see the patient via a video screen. The load for an
MRI scan is approximately 45 minutes; in principle, nothing is noticed of the
magnetic waves. One scan consists of several recordings .. This includes a lot
of sound, for which one gets earplugs or headphones, but the sound of the MRI
will be heard above the music. People with severe claustrophobia sometimes do
not dare to take the MRl.
Geert Grooteplein 10
Nijmegen 6525GA
NL
Geert Grooteplein 10
Nijmegen 6525GA
NL
Listed location countries
Age
Inclusion criteria
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
Exclusion criteria
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL71302.091.19 |