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Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT00412048
Recruitment Status : Withdrawn
First Posted : December 15, 2006
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Study Description
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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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease.
Study Start Date : April 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects [ Time Frame: 1, 5 years ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00412048


Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
Principal Investigator: Francois Sellal, MD Hôpitaux Universitaires de Strasbourg
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00412048     History of Changes
Other Study ID Numbers: 3659
First Posted: December 15, 2006    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders