NCT00951197

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
318

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2009

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

April 30, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

April 22, 2009

Last Update Submit

April 27, 2012

Conditions

Keywords

dementiaAlzheimer's DiseasediagnosticbiomarkersneuroimagingPETMRImild cognitive impairment

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (3)

  • FA, MTR and T2 measures in subjects with mild cognitive impairment no dementia

    day 0

  • Performances in the 7 neuropsychological tests available in the AMI cohort

    day 0

  • FA measures for the connexion Hippocampus-cingulum posterior

    day 0

Study Arms (1)

elderly subjects retired from agriculture

Other: Neuroimaging

Interventions

Three successive MRI acquisitions to measure FA, MTR and T2 parameters.

elderly subjects retired from agriculture

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

DementiaAlzheimer DiseaseDiseaseCognitive Dysfunction

Interventions

Neuroimaging

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental DisordersTauopathiesNeurodegenerative DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsCognition Disorders

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDiagnostic Techniques, NeurologicalInvestigative Techniques

Study Officials

  • Michèle ALLARD

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2009

First Posted

August 4, 2009

Study Start

April 1, 2009

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

April 30, 2012

Record last verified: 2012-04

Locations