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

NCT ID: NCT05756270

Last Updated: 2023-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-06-03

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Mild Cognitive Impairment Subjective Cognitive Decline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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pCASL

Brain 3 Tesla MRI with pCASL sequence

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Milano Bicocca

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondazione IRCCS San Gerardo dei Tintori

Monza, MB, Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Carlo Ferrarese, MD, PhD

Role: CONTACT

+390392333595

Facility Contacts

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Carlo Ferrarese, MD, PhD

Role: primary

+390392333595

Other Identifiers

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CAPE

Identifier Type: -

Identifier Source: org_study_id

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