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

Mild Cognitive Impairment Clinical Trial

— CAPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05756270
• Other study ID #: CAPE
• Status: Recruiting
• Start date: June 3, 2022
• Est. completion date: June 2026

Study information

• Verified date: July 2023
• Source: University of Milano Bicocca
• Contact: Carlo Ferrarese, MD, PhD
• Phone: +390392333595
• Email: carlo.ferrarese[@]unimib.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: June 2026
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment
• Subjective Cognitive Decline

Intervention

Diagnostic Test:
• pCASL
Brain 3 Tesla MRI with pCASL sequence

Locations

Country	Name	City	State
Italy	Fondazione IRCCS San Gerardo dei Tintori	Monza	MB

Sponsors (1)

Lead Sponsor	Collaborator
University of Milano Bicocca

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Differences among brain hypoperfusion patterns according to amyloid and tau status	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
Secondary	Correlations between brain hypoperfusion and neuropsychological tests	The investigators will perform correlations between brain hypoperfusion indices for each ROI and various neuropsychological (NPS) test scores	Baseline, 1 year, 2 years
Secondary	Predictive properties of brain hypoperfusion and brain hypometabolism for conversion to dementia	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
Secondary	Correlations between brain hypoperfusion and CSF and blood biomarkers	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