Mild Cognitive ImpairmentCAPENCT05756270
Clinical Applicability of pCASL as a Substitute for FDG-PET in MCI and SCD Patients
An observational study of Mild Cognitive Impairment and Subjective Cognitive Decline, run by University of Milano Bicocca at 1 site in Italy.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Mild Cognitive Impairment, Subjective Cognitive Decline
- What is being tested?
- pCASL
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 3 Jun 2022to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with mild cognitive impairment
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Being tested
- pCASL
- Keywords
- pseudo-continuous arterial spin labeling, fluorodeoxyglucose positron emission tomography, mild cognitive impairment, biomarkers, subjective cognitive decline
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pCASLDiagnostic test
Brain 3 Tesla MRI with pCASL sequence
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: Baseline
Secondary outcomes (4)
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
Measured: Baseline
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
Measured: Baseline, 1 year, 2 years
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
Measured: 1 year, 2 years
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
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start3 Jun 2022
- Primary completion20 Jun 2024
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05756270
- Sponsor's protocol ID
- CAPE
- Acronym
- CAPE
- Status last verified
- Jul 2023
- First submitted
- 22 Feb 2023
- Last updated
- 24 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applicability of Pseudo-continuous Arterial Spin Labeling as a Substitute for FDG-position Emission Tomography in MCI and SCD Patients
- ClinicalTrials.gov ID
- NCT05756270
- Acronym / sponsor ID
- CAPE / CAPE
- Keywords
- pseudo-continuous arterial spin labeling, fluorodeoxyglucose positron emission tomography, mild cognitive impairment, biomarkers, subjective cognitive decline
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Study start
- 3 Jun 2022 (actual)
- Primary completion
- 20 Jun 2024 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with mild cognitive impairment
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pCASLBrain 3 Tesla MRI with pCASL sequence | Diagnostic test | – |
Primary outcome
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
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.
4 secondary outcomes
Differences among brain hypoperfusion patterns according to amyloid and tau status
Time frame: Baseline
Correlations between brain hypoperfusion and neuropsychological tests
Time frame: Baseline, 1 year, 2 years
Predictive properties of brain hypoperfusion and brain hypometabolism for conversion to dementia
Time frame: 1 year, 2 years
Correlations between brain hypoperfusion and CSF and blood biomarkers
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment and Subjective Cognitive Decline, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between brain hypoperfusion and brain hypometabolism at baseline (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.