The project has the following objectives:1. To investigate the diagnostic value of beta amyloid oligomers in CSF and plasma for AD in subjects with mild dementia. 2. To investigate whether beta amyloid oligomers in CSF and plasma can predict AD in…
ID
Source
Brief title
Condition
- Dementia and amnestic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- Area under the curve (AUC) of a Receiver Operating Characteristic (ROC) curve
for the ability of beta amyloid oligomers to differentiate subjects with AD
from control subjects and subjects with other types of dementia.
- AUC of a ROC curve for the ability of beta amyloid oligomers to differentiate
subjects with MCI who progressed to AD at follow-up from those who will remain
stable.
- AUC of ROC curves to investigate the difference in diagnostic accuracy for AD
of beta amyloid oligomers compared to other biomarkers of AD.
- Differences in oligomer levels according to genotype.
- Change over time of oligomer levels in control subjects, subjects with MCI,
and subjects with AD.
Additional outcome for amendment:
- Difference in gene expression profiles between subjects with high and low
beta amyloid oligomer levels.
Secondary outcome
- Correlation between cognitive markers and levels of beta amyloid oligomers
cross-sectionally and over time.
Background summary
Alzheimer*s disease (AD) is one of the most common neurodegenerative disorders.
There are yet no accurate biomarkers for the early stage of the disease. The
goal of the project is to develop new diagnostic markers of AD which can be
used for the early diagnosis and for the monitoring of treatment response in
drug trials. The project focuses on beta amyloid oligomers and the effect of
genes involved in beta amyloid processing on these oligomers. Oligomers have
been recognized as a key pathogen in AD only recently.
Background of the amendment:
Previous studies indicated that subjects with familial AD have different gene
expression profiles compared to control subjects. The relation between beta
amyloid oligomer levels and gene expression profiles has not been investigated
yet.
Study objective
The project has the following objectives:
1. To investigate the diagnostic value of beta amyloid oligomers in CSF and
plasma for AD in subjects with mild dementia.
2. To investigate whether beta amyloid oligomers in CSF and plasma can predict
AD in subjects with mild cognitive impairment.
3. To compare the diagnostic accuracy of the beta amyloid oligomers with that
of known biomarkers of AD.
4. To investigate whether genes involved in beta amyloid processing modify the
levels of beta amyloid oligomers.
5. To investigate the change over time of in beta amyloid oligomers in CSF and
plasma.
Objectives added as part of amendment:
6. To investigate which set of gene expression profiles are associated with
beta amyloid oligomer levels both cross-sectionally and longitudinally
7. To compare the diagnostic accuracy of beta amyloid oligomer levels for a
diagnosis of AD with that of gene expression
profiles.
Study design
Cross-sectional study and prospective cohort study
Study burden and risks
There are no direct potential benefits for the participants but the study is
likely to increase the diagnostic accuracy for AD which will be beneficial for
future patients with cognitive impairments. Lumbar puncture is safe and well
tolerated. Collection of CSF samples may be accompanied by post-lumbar puncture
headache in less than 5% of the patients but this complication is reversible.
Other complications such as bleeding, infection, or leakage have been described
but these are very uncommon. They have not been noted by the clinical centres
in the study which have already performed lumbar puncture for research purposes
during the past five years in over 1000 subjects.
Postbus 7057
1007 MB Amsterdam
NL
Postbus 7057
1007 MB Amsterdam
NL
Listed location countries
Age
Inclusion criteria
Dementia or mild cognitive impairment according to established clinical criteria
Exclusion criteria
Contra indication for lumbar puncture
Score on Mini Mental State examination below 18
Co-morbid disorders that have a major impact on cognition
Age below 40 (demented subjects and controls) or below 60 (subjects with mild cognitive impairment)
Cognitive impairment (control subjects)
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 | NL18420.029.07 |