Beta amyloid oligomers in the early diagnosis of AD and as marker for treatment response
- Conditions
- Alzheimer's disease10012272
- Registration Number
- NL-OMON31716
- Lead Sponsor
- Vrije Universiteit Medisch Centrum
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 100
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)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>- Area under the curve (AUC) of a Receiver Operating Characteristic (ROC) curve<br /><br>for the ability of beta amyloid oligomers to differentiate subjects with AD<br /><br>from control subjects and subjects with other types of dementia.<br /><br>- AUC of a ROC curve for the ability of beta amyloid oligomers to differentiate<br /><br>subjects with MCI who progressed to AD at follow-up from those who will remain<br /><br>stable.<br /><br>- AUC of ROC curves to investigate the difference in diagnostic accuracy for AD<br /><br>of beta amyloid oligomers compared to other biomarkers of AD.<br /><br>- Differences in oligomer levels according to genotype.<br /><br>- Change over time of oligomer levels in control subjects, subjects with MCI,<br /><br>and subjects with AD.<br /><br><br /><br>Additional outcome for amendment:<br /><br>- Difference in gene expression profiles between subjects with high and low<br /><br>beta amyloid oligomer levels.</p><br>
- Secondary Outcome Measures
Name Time Method <p>- Correlation between cognitive markers and levels of beta amyloid oligomers<br /><br>cross-sectionally and over time.</p><br>