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Clinical Applicability of pCASL as a Substitute for FDG-PET in MCI and SCD Patients

Clinical Applicability of Pseudo-continuous Arterial Spin Labeling as a Substitute for FDG-position Emission Tomography in MCI and SCD Patients

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05756270
Acronym
CAPE
Enrollment
150
Registered
2023-03-06
Start date
2022-06-03
Completion date
2026-03-01
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment, Subjective Cognitive Decline

Keywords

pseudo-continuous arterial spin labeling, fluorodeoxyglucose positron emission tomography, mild cognitive impairment, biomarkers, subjective cognitive decline

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.

Interventions

DIAGNOSTIC_TESTpCASL

Brain 3 Tesla MRI with pCASL sequence

Sponsors

University of Milano Bicocca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Correlation between brain hypoperfusion and brain hypometabolism at baselineBaselineThe 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 profileBaselineThe 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

MeasureTime frameDescription
Differences among brain hypoperfusion patterns according to amyloid and tau statusBaselineThe investigators will analyze differences in brain perfusion indices for each ROI among patients wit amyloid positive status, amyloid and tau negative status, and amyloid negative - tau positive status
Correlations between brain hypoperfusion and neuropsychological testsBaseline, 1 year, 2 yearsThe investigators will perform correlations between brain hypoperfusion indices for each ROI and various neuropsychological (NPS) test scores
Predictive properties of brain hypoperfusion and brain hypometabolism for conversion to dementia1 year, 2 yearsThe investigators will analyze correlations between each ROI hypoperfusion and conversion to dementia rates within the prespecified time frame. In case of significant associations, a receiver operating characteristic curve (ROC) analysis will be carried out to individuate optimal cut-offs for cerebral blood flow indices and SUVr to predict conversion of dementia
Correlations between brain hypoperfusion and CSF and blood biomarkersBaselineThe investigators will perform correlations between brain hypoperfusion indices for each ROI and values of CSF and blood amyloid beta, phosphorylated tau and total tau

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026