Alzheimer's DiseaseNCT00412048
Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease
A study testing fMRI to detect MCI patients who will convert to Alzheimer's disease in people with Alzheimer's Disease, run by University Hospital, Strasbourg, France.
Trial summary
The aim of the protocol is to study the resting brain activation profile of 3 groups of people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25 Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive impairment (MCI) - a clinical picture which may be a… Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- fMRI to detect MCI patients who will convert to Alzheimer's disease
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Apr 2012to Feb 2018
- Phase
- Interventional
- 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 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Alzheimer's disease of mild to moderate severity (25 patients)
- Amnestic MCI patients (25 patients)
- 55-75 year-old patients
Who cannot join
- Any other cause of dementia for AD patients
- Any stroke
- Any disease with a negative vital prognosis
About this study
Official title: Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease.
The aim of the protocol is to study the resting brain activation profile of 3 groups of people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25 Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive impairment (MCI) - a clinical picture which may be a prodromal form of AD - and 60 healthy controls. The first analysis of the data will search differences of brain activation profiles between the 3 groups. In the second step, the investigators will study the predictive value of fMRI-SAM to detect MCI patients who will later convert to AD.
- Conditions
- Alzheimer's Disease
- Being tested
- fMRI to detect MCI patients who will convert to Alzheimer's disease
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRI to detect MCI patients who will convert to Alzheimer's diseaseProcedure or surgery
There is a fMRI to be realized in the 3 arms. No drug is administered
| Study group | Role | What they receive |
|---|---|---|
| ALZHEIMER DISEASE | Other | Not described Receives: Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease |
| MOLD COGNITIVE IMPAIRMENT | Other | Not described Receives: Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease |
| CONTROLS | Other | Not described Receives: Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects
Measured: 1, 5 years
Secondary outcomes (1)
Follow-up of MCI patients at 6, 12 and 18 months to detect a conversion to Alzheimer's disease
Measured: Prediction of Alzheimer's disease on fMRI data
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2006 (estimated)
- Study startApr 2012
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
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.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Francois Sellal, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00412048
- Sponsor's protocol ID
- 3659
- Status last verified
- Nov 2012
- First submitted
- 14 Dec 2006
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease.
- ClinicalTrials.gov ID
- NCT00412048
- Acronym / sponsor ID
- 3659
- Conditions
- Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Apr 2012 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 15 Dec 2006 (estimated)
- 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.
The aim of the protocol is to study the resting brain activation profile of 3 groups of people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25 Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive impairment (MCI) - a clinical picture which may be a prodromal form of AD - and 60 healthy controls. The first analysis of the data will search differences of brain activation profiles between the 3 groups. In the second step, the investigators will study the predictive value of fMRI-SAM to detect MCI patients who will later convert to AD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALZHEIMER DISEASE | Other | Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease |
| MOLD COGNITIVE IMPAIRMENT | Other | Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease |
| CONTROLS | Other | Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Alzheimer's disease of mild to moderate severity (25 patients)
- Amnestic MCI patients (25 patients)
- 55-75 year-old patients
Key exclusion criteria (3 listed)
- Any other cause of dementia for AD patients
- Any stroke
- Any disease with a negative vital prognosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRI to detect MCI patients who will convert to Alzheimer's diseaseThere is a fMRI to be realized in the 3 arms. No drug is administered | Procedure or surgery | ALZHEIMER DISEASE, CONTROLS, MOLD COGNITIVE IMPAIRMENT |
Primary outcome
Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects
Time frame: 1, 5 years
1 secondary outcome
Follow-up of MCI patients at 6, 12 and 18 months to detect a conversion to Alzheimer's disease
Time frame: Prediction of Alzheimer's disease on fMRI data
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
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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.
Francois Sellal, MD principal investigator
Hôpitaux Universitaires de Strasbourg
Questions about this trial
What is this clinical trial studying?
A study testing fMRI to detect MCI patients who will convert to Alzheimer's disease in people with Alzheimer's Disease, run by University Hospital, Strasbourg, 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 3 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: withdrawn, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects (time frame: 1, 5 years). 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 8 Jun 2026.