Alzheimer's DiseaseNCT06965816
Using Neuroimaging to Early Diagnose Alzheimer's Disease Through Hippocampal Atrophy Assessment
An observational study of Alzheimer's Disease and Hippocampus, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Hippocampus, Brain Atrophy
- How many people
- 85 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2022to 24 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Incomplete clinical or radiological data.
- Poor image quality (e.g., motion artifacts).
- Presence of other neurodegenerative or psychiatric disorders.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Alzheimer's Disease, Hippocampus, Brain Atrophy, Magnetic Resonance Imaging, Leukoaraiosis, Neurodegenerative Diseases
- Medical subject headings
- Leukoaraiosis, Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer Group | Alzheimer's patients | |
| Control Group | Unreached witnesses |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospective analysis between January 2018 and June 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start24 Nov 2022
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965816
- Sponsor's protocol ID
- 0030_IMAGERIE
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 11 May 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Neuroimaging to Early Diagnose Alzheimer's Disease Through Hippocampal Atrophy Assessment
- ClinicalTrials.gov ID
- NCT06965816
- Acronym / sponsor ID
- 0030_IMAGERIE
- Conditions
- Alzheimer's Disease, Hippocampus, Brain Atrophy, Magnetic Resonance Imaging, Leukoaraiosis, Neurodegenerative Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer Group | – | –Alzheimer's patients |
| Control Group | – | –Unreached witnesses |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Incomplete clinical or radiological data.
- Poor image quality (e.g., motion artifacts).
- Presence of other neurodegenerative or psychiatric disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Hippocampal Volume Measured by 3D MRI
Time frame: Retrospective analysis between January 2018 and June 2022
Objective volumetric measurement of the right and left hippocampus using 3D T1 Bravo MRI sequences, allowing quantification of hippocampal atrophy.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease and Hippocampus, run by Centre Hospitalier de Saint-Denis at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hippocampal Volume Measured by 3D MRI (time frame: Retrospective analysis between January 2018 and June 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.