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Completed

NCT Number: NCT05756270

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

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.

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders Subjective Cognitive Decline

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pCASL

Diagnostic Test

Brain 3 Tesla MRI with pCASL sequence

Primary outcomes

  1. 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

  2. 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

  1. Differences among brain hypoperfusion patterns according to amyloid and tau status

    Time frame: Baseline

    The 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

  2. Correlations between brain hypoperfusion and neuropsychological tests

    Time frame: Baseline, 1 year, 2 years

    The investigators will perform correlations between brain hypoperfusion indices for each ROI and various neuropsychological (NPS) test scores

  3. Predictive properties of brain hypoperfusion and brain hypometabolism for conversion to dementia

    Time frame: 1 year, 2 years

    The 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

  4. Correlations between brain hypoperfusion and CSF and blood biomarkers

    Time frame: Baseline

    The investigators will perform correlations between brain hypoperfusion indices for each ROI and values of CSF and blood amyloid beta, phosphorylated tau and total tau

Sponsors and collaborators

Lead sponsor

University of Milano Bicocca

Other

Registry information

Official study title

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

Acronym: CAPE

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Mar 6, 2023
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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