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

April 27, 2012 updated by: University Hospital, Bordeaux

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.

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

318

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bordeaux, France, 33076
        • Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

population retired from agricultural profession and living in rural area in Gironde

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Ecologic or Community
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
elderly subjects retired from agriculture
Other: Neuroimaging
Three successive MRI acquisitions to measure FA, MTR and T2 parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
day 0

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

April 22, 2009

First Submitted That Met QC Criteria

August 3, 2009

First Posted (Estimate)

August 4, 2009

Study Record Updates

Last Update Posted (Estimate)

April 30, 2012

Last Update Submitted That Met QC Criteria

April 27, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX2008/13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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