Clinical trial NCT05756270: Clinical Applicability of pCASL as a Substitute for FDG-PET in MCI and SCD Patients
Official title: Clinical Applicability of Pseudo-continuous Arterial Spin Labeling as a Substitute for FDG-position Emission Tomography in MCI and SCD Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mild Cognitive Impairment
Subjective Cognitive Decline
Keywords: pseudo-continuous arterial spin labeling
fluorodeoxyglucose positron emission tomography
mild cognitive impairment
biomarkers
subjective cognitive decline
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with mild cognitive impairment

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.


Eligibility criteria: 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

Primary outcomes:
measure: Correlation between brain hypoperfusion and brain hypometabolism at baseline
timeFrame: Baseline
measure: Correlation between brain hypoperfusion and brain hypometabolism at baseline according to CSF profile
timeFrame: Baseline
Secondary outcomes:
measure: Differences among brain hypoperfusion patterns according to amyloid and tau status
timeFrame: Baseline
measure: Correlations between brain hypoperfusion and neuropsychological tests
timeFrame: Baseline, 1 year, 2 years
measure: Predictive properties of brain hypoperfusion and brain hypometabolism for conversion to dementia
timeFrame: 1 year, 2 years
measure: Correlations between brain hypoperfusion and CSF and blood biomarkers
timeFrame: Baseline
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Fondazione IRCCS San Gerardo dei Tintori
state: MB
Study officials:
References: