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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This study has been withdrawn prior to enrollment.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:
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
  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:


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
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

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
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014