Neuro-Degenerative DiseaseNCT06164938
Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.
An observational study of Neuro-Degenerative Disease, run by IRCCS San Raffaele.
Trial summary
The aim of the study is to obtain information on cerebral glucose metabolism measured with the 18F-FDG PET technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects … Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Neuro-Degenerative Disease
- What is being tested?
- Diagnostic accuracy
- How many people
- 23 participants
- Where
- No sites listed yet
- Study dates
- 14 Apr 2010to 12 Jan 2011
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 40 healthy volunteers, over 40 years of age, capable of understanding and wanting, who have not had a previous clinical history of neurological or psychiatric diseases, will be enrolled. Subjects with cognitive impairment and who at the time of recruitment are taking drugs active on the central nervous system will be excluded.
Who may be able to join
- absence of neurological and psychiatric pathologies, negative pregnancy test.
Who cannot join
None listed.
About this study
The aim of the study is to obtain information on cerebral glucose metabolism measured with the 18F-FDG PET technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects ( patients with disease neurological or psychiatric) which will be evaluated with the same method to improve the specificity and diagnostic sensitivity of the FDG PET exam.
The objective is to obtain a functional measure of brain glucose metabolism in every normal subject because this is a functional measure of brain activity. The subjects will represent different decades of age to have a wider range of comparison with patients.
- Conditions
- Neuro-Degenerative Disease
- Being tested
- Diagnostic accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic accuracyDiagnostic test
The aim is to obtain a regional measure of brain glucose metabolism in each normal subject because this is a functional measure of brain activity.
What is being measured
The primary outcome is the main question the study is designed to answer.
Study of glucose metabolism with 18 F FDG PET
Study of glucose metabolism with 18 F FDG PET in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for statistical analyzes for comparison with individual subjects (patients with neurological or psychiatric) which will be evaluated with the same method to improve the diagnostic sensitivity of the FDG PET exam.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start14 Apr 2010
- Primary completion12 Jan 2011
- Study completion12 Jan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuro-Degenerative DiseaseStudies of the same condition, open and under way.
- More trials run by IRCCS San RaffaeleThe sponsor's other registered studies.
- 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
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chiti Arturo, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06164938
- Sponsor's protocol ID
- FDG-NORM
- Status last verified
- Dec 2023
- First submitted
- 1 Dec 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cerebral Glucose Metabolism in Healthy Volunteers Using 18 F-FDG PET: Evaluation of the Effects of Aging, Comparative Evaluation of Neurodegenerative and Psychiatric Pathologies.
- ClinicalTrials.gov ID
- NCT06164938
- Acronym / sponsor ID
- FDG-NORM
- Conditions
- Neuro-Degenerative Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Study start
- 14 Apr 2010 (actual)
- Primary completion
- 12 Jan 2011 (actual)
- Study completion
- 12 Jan 2011 (actual)
- First posted
- 11 Dec 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 aim of the study is to obtain information on cerebral glucose metabolism measured with the 18F-FDG PET technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects ( patients with disease neurological or psychiatric) which will be evaluated with the same method to improve the specificity and diagnostic sensitivity of the FDG PET exam.
The objective is to obtain a functional measure of brain glucose metabolism in every normal subject because this is a functional measure of brain activity. The subjects will represent different decades of age to have a wider range of comparison with patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 40 healthy volunteers, over 40 years of age, capable of understanding and wanting, who have not had a previous clinical history of neurological or psychiatric diseases, will be enrolled. Subjects with cognitive impairment and who at the time of recruitment are taking drugs active on the central nervous system will be excluded.
Key inclusion criteria (1 listed)
- absence of neurological and psychiatric pathologies, negative pregnancy test.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Diagnostic accuracyThe aim is to obtain a regional measure of brain glucose metabolism in each normal subject because this is a functional measure of brain activity. | Diagnostic test | – |
Primary outcome
Study of glucose metabolism with 18 F FDG PET
Time frame: 1 year
Study of glucose metabolism with 18 F FDG PET in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for statistical analyzes for comparison with individual subjects (patients with neurological or psychiatric) which will be evaluated with the same method to improve the diagnostic sensitivity of the FDG PET exam.
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 11 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuro-Degenerative Disease, run by IRCCS San Raffaele.
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 1 inclusion and 0 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 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
Study of glucose metabolism with 18 F FDG PET (time frame: 1 year). 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 11 Dec 2023.