NCT06965816

Brief Summary

This study aims to better understand Alzheimer's disease by looking at brain scans, specifically MRI images, to detect early signs of brain changes linked to the disease. Researchers are focusing on the hippocampus, a part of the brain that shrinks in people with Alzheimer's. The study will also explore other brain changes that often happen alongside hippocampal shrinkage. By analyzing these brain images, the study hopes to find ways to diagnose Alzheimer's earlier and more accurately using advanced imaging techniques.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
85

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 24, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

May 2, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 11, 2025

Completed
Last Updated

May 11, 2025

Status Verified

May 1, 2025

Enrollment Period

6 months

First QC Date

May 2, 2025

Last Update Submit

May 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Hippocampal Volume Measured by 3D MRI

    Objective volumetric measurement of the right and left hippocampus using 3D T1 Bravo MRI sequences, allowing quantification of hippocampal atrophy.

    Retrospective analysis between January 2018 and June 2022

Study Arms (2)

Alzheimer Group

Alzheimer's patients

Control Group

Unreached witnesses

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be selected from a retrospective cohort of patients who underwent brain MRI scans (3D T1 Bravo and Cube FLAIR sequences) between January 2018 and June 2022. The study population includes two groups: patients diagnosed with Alzheimer's disease based on clinical and biological assessments, and cognitively healthy individuals with no history of neurological or psychiatric disorders, serving as controls.

You may qualify if:

  • Patients who underwent a brain MRI (3D T1 Bravo and Cube FLAIR sequences) between January 2018 and June 2022.
  • Diagnosis of Alzheimer's disease (for the Alzheimer group).
  • No neurological disease for control group participants.
  • Complete clinical and biological assessments available.
  • Quality imaging without motion artifacts.

You may not qualify if:

  • Incomplete clinical or radiological data.
  • Poor image quality (e.g., motion artifacts).
  • Presence of other neurodegenerative or psychiatric disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Saint-Denis, France

Location

MeSH Terms

Conditions

LeukoaraiosisNeurodegenerative Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2025

First Posted

May 11, 2025

Study Start

November 24, 2022

Primary Completion

May 24, 2023

Study Completion

May 24, 2023

Last Updated

May 11, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations