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

Alzheimer Disease Clinical Trial

— AMIMAGE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00951197
• Other study ID #: CHUBX2008/13
• Status: Completed
• Phase: N/A
• First received: April 22, 2009
• Last updated: April 27, 2012
• Start date: April 2009
• Est. completion date: March 2011

Study information

• Verified date: April 2012
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Observational

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 318
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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 Design

Observational Model: Ecologic or Community, Time Perspective: Prospective

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

Other:
• Neuroimaging
Three successive MRI acquisitions to measure FA, MTR and T2 parameters.

Locations

Country	Name	City	State
France	Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		day 0	No
Secondary	FA, MTR and T2 measures in subjects with mild cognitive impairment no dementia		day 0	No
Secondary	Performances in the 7 neuropsychological tests available in the AMI cohort		day 0	No
Secondary	FA measures for the connexion Hippocampus-cingulum posterior		day 0	No