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

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00412048
First Posted: December 15, 2006
Last Update Posted: November 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Strasbourg, France
  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: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease.

Resource links provided by NLM:


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 ]

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 ]

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

Information from the National Library of Medicine

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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
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

Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT00412048     History of Changes
Other Study ID Numbers: 3659
First Submitted: December 14, 2006
First Posted: December 15, 2006
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