Study of Iron Accumulation Measured in MRI in Non-patholo... | NCT04659824

Studies
Study of Iron Accumulation Measured in MRI in Non-pathological Aging

NCT04659824

Sponsor

University Hospital, Lille

Status

Recruiting

Last Update Posted

May 29, 2025Actual

Enrollment

190Estimated

Phase

Not provided

Conditions

Healthy Aging

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A00491-38	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 30, 2023Actual

Primary Completion Date

Jan 2029Estimated

Completion Date

Jan 2029Estimated

First Submitted Date

Dec 2, 2020

First Submission Date that Met QC Criteria

Dec 2, 2020

First Posted Date

Dec 9, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 22, 2025

Last Update Posted Date

May 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

190Estimated

Label	Type	Description	Intervention Names
Healthy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation coefficient between iron load in MRI and age		baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Healthy subjects from 18 to 95 years old stratified by sex and age groups

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Grégory KUCHCINSKI, MD	Contact	0320445962	+33	gregory.kuchcinski@chru-lille.fr

Overall Officials

Name	Affiliation	Role
Grégory KUCHCINSKI, MD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hopital Roger Salengro, CHU Lille	Recruiting	Lille		59037	France