NCT04659824

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
32mo left

Started Jan 2023

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress55%
Jan 2023Jan 2029

First Submitted

Initial submission to the registry

December 2, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 9, 2020

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 30, 2023

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2029

Last Updated

May 29, 2025

Status Verified

May 1, 2025

Enrollment Period

5.9 years

First QC Date

December 2, 2020

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Correlation coefficient between iron load in MRI and age

    baseline

Study Arms (1)

Healthy

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Men or women between 18 and 95 years old
  • French speaker with capability to understand the instructions
  • Health insurance

You may not qualify if:

  • Pregnancy
  • minor subject
  • no informed consent agreement
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

RECRUITING

Study Officials

  • Grégory KUCHCINSKI, MD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégory KUCHCINSKI, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2020

First Posted

December 9, 2020

Study Start

January 30, 2023

Primary Completion (Estimated)

January 1, 2029

Study Completion (Estimated)

January 1, 2029

Last Updated

May 29, 2025

Record last verified: 2025-05

Locations