- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04659824
Study of Iron Accumulation Measured in MRI in Non-pathological Aging (FER-IRM)
May 22, 2025 updated by: University Hospital, Lille
To study the correlation between the iron load in brain, measured in MRI, and the age of healthy subjects Secondary objectives are to study the correlations between the iron load in cortical brain regions and (i) the cognitive performances, (ii) markers of aging (MRI, EEG, OCT, biology),and (iii) demographical factors involved in iron load.
Study Overview
Status
Recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
190
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Grégory KUCHCINSKI, MD
- Phone Number: +33 0320445962
- Email: gregory.kuchcinski@chru-lille.fr
Study Locations
-
-
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Lille, France, 59037
- Recruiting
- Hopital Roger Salengro, CHU Lille
-
-
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
18 years to 95 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Healthy subjects from 18 to 95 years old stratified by sex and age groups
Description
Inclusion Criteria:
- Men or women between 18 and 95 years old
- French speaker with capability to understand the instructions
- Health insurance
Exclusion Criteria:
- Pregnancy
- minor subject
- no informed consent agreement
- subject enrolled in pharmaceutic study or exclusion period
- MRI contra-indications
- Neurological or psychiatric disorders
- MOCA < 26
- Psychotropic drugs
- More than 3 MRI exams
- More than 1 neuropsychological assessment (same cognitive tests) in the last 12 months
- Unable to follow the entire protocol according to the investigator
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
Cohorts and Interventions
Group / Cohort |
|---|
|
Healthy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Correlation coefficient between iron load in MRI and age
Time Frame: baseline
|
baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Grégory KUCHCINSKI, MD, University Hospital, Lille
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)
January 30, 2023
Primary Completion (Estimated)
January 1, 2029
Study Completion (Estimated)
January 1, 2029
Study Registration Dates
First Submitted
December 2, 2020
First Submitted That Met QC Criteria
December 2, 2020
First Posted (Actual)
December 9, 2020
Study Record Updates
Last Update Posted (Actual)
May 29, 2025
Last Update Submitted That Met QC Criteria
May 22, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- 2019_24
- 2020-A00491-38 (Other Identifier: ID-RCB number,ANSM)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
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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