Clinical Applicability of Pseudo-continuous Arterial Spin Labeling as a Substitute for FDG-position Emission Tomography in MCI and SCD Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Milano Bicocca
- Enrollment
- 150
- Locations
- 1
- Primary Endpoint
- Correlation between brain hypoperfusion and brain hypometabolism at baseline
Study Overview
Brief Summary
The goal of this observational study is to compare cerebral perfusion patterns with pseudo-continuous arterial spin labeling (pCASL) and brain metabolism patterns with fluorodeoxyglucose-position emission tomography (FDG-PET) in patients with mild cognitive impairment (MCI) and subjective cognitive decline (SCD). The main questions it aims to answer are:
- Do pCASL sequences identify hypoperfusion patterns that correlate well with FDG-PET hypometabolic patterns?
- Are there differences in this correlation in terms of cerebrospinal fluid (CSF) profiles?
- Can hypoperfusion patterns in pCASL predict conversion to dementia? Participants will undergo brain 3 Tesla magnetic resonance imaging (MRI), FDG-PET, lumbal puncture and blood collection to analyze amyloid beta and tau, yearly detailed neuropsychological tests for three years.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with mild cognitive impairment or subjective cognitive decline according to established criteria
- •Clinical Dementia Rating scale of 0 or 0.5
- •Signed informed consent before study entry
Exclusion Criteria
- •Contraindication to brain MRI, FDG-PET or lumbar puncture
- •Secondary causes of cognitive decline
- •Known major neurological or psychiatric comorbidities
- •History of substance or alcohol abuse
- •Known causes of cerebral brain perfusion alterations
- •Enrollment in anti-amyloid or anti-tau drugs trials
Outcomes
Primary Outcomes
Correlation between brain hypoperfusion and brain hypometabolism at baseline
Time Frame: Baseline
The investigators will correlate cerebral perfusion indices and standardized uptake value ratios (SUVr) ratios for each pre-specified region of interest (ROI) within statistical parametric mapping (SPM) Automatic Anatomic Labeling (AAL), after coregistration on T1 sequences
Correlation between brain hypoperfusion and brain hypometabolism at baseline according to CSF profile
Time Frame: Baseline
The investigators will correlate cerebral perfusion indices and SUVr for each pre-specified ROI (region of interest) within SPM Automatic Anatomic Labeling (AAL), after coregistration on T1 sequences. This analysis will be done within subgroups according to CSF status according to amyloid beta, phosphorylated tau and total tau.
Secondary Outcomes
- Differences among brain hypoperfusion patterns according to amyloid and tau status(Baseline)
- Correlations between brain hypoperfusion and CSF and blood biomarkers(Baseline)
- Correlations between brain hypoperfusion and neuropsychological tests(Baseline, 1 year, 2 years)
- Predictive properties of brain hypoperfusion and brain hypometabolism for conversion to dementia(1 year, 2 years)