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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00951197
First received: April 22, 2009
Last updated: April 27, 2012
Last verified: April 2012
History of Changes
  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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00951197     History of Changes
Other Study ID Numbers: CHUBX2008/13
Study First Received: April 22, 2009
Last Updated: April 27, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013