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.

December 1, 2023 updated by: Chiti Arturo, IRCCS San Raffaele

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 Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

23

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • absence of neurological and psychiatric pathologies, negative pregnancy test.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 14, 2010

Primary Completion (Actual)

January 12, 2011

Study Completion (Actual)

January 12, 2011

Study Registration Dates

First Submitted

December 1, 2023

First Submitted That Met QC Criteria

December 1, 2023

First Posted (Estimated)

December 11, 2023

Study Record Updates

Last Update Posted (Estimated)

December 11, 2023

Last Update Submitted That Met QC Criteria

December 1, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FDG-NORM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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