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

NCT05756270 | Completed

• 1 other identifier: CAPE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Subjective Cognitive Decline

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Correlation between brain hypoperfusion and brain hypometabolism at 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

  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 Outcomes (4)

• Differences among brain hypoperfusion patterns according to amyloid and tau status

  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

• Correlations between brain hypoperfusion and CSF and blood biomarkers

  Baseline

Interventions

pCASL DIAGNOSTIC_TEST

Brain 3 Tesla MRI with pCASL sequence

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with mild cognitive impairment

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Milano Bicocca: lead

Study Sites (1)

Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, 20900, Italy

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood and CSF samples

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2023
• First Posted: March 6, 2023
• Study Start: June 3, 2022
• Primary Completion: June 20, 2024
• Study Completion: March 1, 2026
• Last Updated: March 24, 2026

Record last verified: 2023-07

Locations

IT (1)