Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease
This study has been withdrawn prior to enrollment.
Sponsor:
University Hospital, Strasbourg, France
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier:
NCT00412048
First received: December 14, 2006
Last updated: November 12, 2012
Last verified: November 2012
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Alzheimer's Disease |
Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease. |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by University Hospital, Strasbourg, France:
Primary Outcome Measures:
- Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects [ Time Frame: 1, 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | April 2012 |
| Estimated Study Completion Date: | February 2018 |
| Estimated Primary Completion Date: | February 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| ALZHEIMER DISEASE |
Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease
There is a fMRI to be realized in the 3 arms. No drug is administered
|
| MOLD COGNITIVE IMPAIRMENT |
Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease
There is a fMRI to be realized in the 3 arms. No drug is administered
|
| CONTROLS |
Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease
There is a fMRI to be realized in the 3 arms. No drug is administered
|
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion criteria:
- Alzheimer's disease of mild to moderate severity (25 patients)
- Amnestic MCI patients (25 patients)
- 55-75 year-old patients
Exclusion criteria:
- Any other cause of dementia for AD patients
- Any stroke
- Any disease with a negative vital prognosis
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00412048
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412048
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
| Principal Investigator: | Francois Sellal, MD | Hôpitaux Universitaires de Strasbourg |
More Information
| Responsible Party: | University Hospital, Strasbourg, France |
| ClinicalTrials.gov Identifier: | NCT00412048 History of Changes |
| Other Study ID Numbers: | 3659 |
| Study First Received: | December 14, 2006 |
| Last Updated: | November 12, 2012 |
| Health Authority: | France: Afssaps |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on September 27, 2016