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Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease
This study is currently recruiting participants.
Verified by University Hospital, Strasbourg, France, November 2008
Sponsored by: University Hospital, Strasbourg, France
Information provided by: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00412048
  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

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease MRI Scans
U.S. FDA Resources
Study Type: Observational
Study Design: Prospective
Official Title: Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease.

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 ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Estimated Enrollment: 110
Study Start Date: June 2007
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
AD 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
MCI 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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Patients recruited during consultations

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00412048

Contacts
Contact: François Sellal, MD 33.3.88.11.66.62 francois.sellal@chru-strasbourg.fr francois.sellal@ch-colmar.rss.fr

Locations
France
Service de Neurologie, Hôpital Civil, Recruiting
Strasbourg, France, 67091
Contact: Francois Sellal, MD     33.3.88.11.66.62     francois.sellal@chru-strasbourg.fr    
Principal Investigator: François Sellal, MD            
Sub-Investigator: Izzie Jacques Namer, MD            
Sub-Investigator: Stéphane Kremer, MD            
Sub-Investigator: Jack Foucher, MD            
Sub-Investigator: Frédéric Blanc, MD            
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 ( Emmanuel Lavoue, Directeur Adjoint de la DRCI )
Study ID Numbers: 3659
Study First Received: December 14, 2006
Last Updated: November 17, 2008
ClinicalTrials.gov Identifier: NCT00412048  
Health Authority: France: Ministry of Health

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Nervous System Diseases
Tauopathies

ClinicalTrials.gov processed this record on January 14, 2009