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Evaluation of Alteration by Magnetic Resonance Imaging (MRI) in Dementia Among Elderly Subjects (AMIMAGE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00951197
First Posted: August 4, 2009
Last Update Posted: April 30, 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, Bordeaux
  Purpose
Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as diagnostic standards in research. However, the research on AD progresses and some biomarkers have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance Imaging (MRI).

Condition Intervention
Dementia Alzheimer Disease Other: Neuroimaging

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Estimation of Microstructure Alteration by MRI in Dementia Among Elderly Subjects Retired From Agricultural Profession and Living in Rural Area in Gironde - Participants From the AMI Cohort.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • FA (Fractional Anisotropy), MTR (magnetization transfer ratio) and T2 (Transverse relaxation time) measures in patients with dementia compared to controls, in left and right hippocampus, and posterior cingulum [ Time Frame: day 0 ]

Secondary Outcome Measures:
  • FA, MTR and T2 measures in subjects with mild cognitive impairment no dementia [ Time Frame: day 0 ]
  • Performances in the 7 neuropsychological tests available in the AMI cohort [ Time Frame: day 0 ]
  • FA measures for the connexion Hippocampus-cingulum posterior [ Time Frame: day 0 ]

Enrollment: 318
Study Start Date: April 2009
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
elderly subjects retired from agriculture Other: Neuroimaging
Three successive MRI acquisitions to measure FA, MTR and T2 parameters.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
population retired from agricultural profession and living in rural area in Gironde
Criteria

Inclusion Criteria:

  • participate in the AMI cohort
  • be aged 65 and older
  • be retired from agricultural profession
  • live in rural area in Gironde

Exclusion Criteria:

  • contraindication of MRI
  • left-handed
  • severe dementia
  • Parkinson's disease
  • poor health incompatible with the transport to neuroimaging service
  • to be left handed
  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): NCT00951197


Locations
France
Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux
Bordeaux, France, 33076
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Michèle ALLARD University Hospital, Bordeaux
  More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00951197     History of Changes
Other Study ID Numbers: CHUBX2008/13
First Submitted: April 22, 2009
First Posted: August 4, 2009
Last Update Posted: April 30, 2012
Last Verified: April 2012

Keywords provided by University Hospital, Bordeaux:
dementia
Alzheimer's Disease
diagnostic
biomarkers
neuroimaging
PET
MRI
mild cognitive impairment

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