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

March 23, 2026 updated by: University of Milano Bicocca

Clinical Applicability of Pseudo-continuous Arterial Spin Labeling as a Substitute for FDG-position Emission Tomography 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • MB
      • Monza, MB, Italy, 20900
        • Fondazione IRCCS San Gerardo Dei Tintori

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with mild cognitive impairment

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline
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
Baseline, 1 year, 2 years
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
1 year, 2 years
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Milano Bicocca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2022

Primary Completion (Actual)

June 20, 2024

Study Completion (Actual)

March 1, 2026

Study Registration Dates

First Submitted

February 22, 2023

First Submitted That Met QC Criteria

February 22, 2023

First Posted (Actual)

March 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 24, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAPE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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