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This study has been withdrawn prior to enrollment.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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 14, 2006 | ||||
| Last Updated Date | November 12, 2012 | ||||
| Start Date ICMJE | April 2012 | ||||
| Estimated Primary Completion Date | February 2018 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE |
Comparing fMRI data between 3 groups of subjects : MCI, Alzheimer’s disease and normal subjects | ||||
| Change History | Complete list of historical versions of study NCT00412048 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE |
Follow-up of MCI patients at 6, 12 and 18 months to detect a conversion to Alzheimer’s disease | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease | ||||
| Official Title ICMJE | Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease. | ||||
| Brief 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 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Alzheimer's Disease | ||||
| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Enrollment ICMJE | 0 | ||||
| Estimated Completion Date | February 2018 | ||||
| Estimated Primary Completion Date | February 2018 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 55 Years to 75 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Not Provided | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00412048 | ||||
| Other Study ID Numbers ICMJE | 3659 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | University Hospital, Strasbourg, France | ||||
| Study Sponsor ICMJE | University Hospital, Strasbourg, France | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University Hospital, Strasbourg, France | ||||
| Verification Date | November 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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