Evaluation of Alteration by Magnetic Resonance Imaging (M... | NCT00951197

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

NCT00951197

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Apr 30, 2012Estimated

Enrollment

318Actual

Phase

Not provided

Conditions

Dementia
Alzheimer Disease

Interventions

Neuroimaging

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Mar 2011Actual

Completion Date

Mar 2011Actual

First Submitted Date

Apr 22, 2009

First Submission Date that Met QC Criteria

Aug 3, 2009

First Posted Date

Aug 4, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 27, 2012

Last Update Posted Date

Apr 30, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

318Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
elderly subjects retired from agriculture			Other: Neuroimaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuroimaging	Other	Three successive MRI acquisitions to measure FA, MTR and T2 parameters.	elderly subjects retired from agriculture

Outcomes Module

Primary Outcomes

Measure	Description	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		day 0

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

65 Years

Maximum Age

Not provided

Standard Ages

Older Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michèle ALLARD	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux		Bordeaux		33076	France

Condition Browse Module

MeSH Terms

ID	Term
D003704	Dementia
D000544	Alzheimer Disease
D004194	Disease
D060825	Cognitive Dysfunction

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D019965	Neurocognitive Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D059906	Neuroimaging

Ancestor Terms

ID	Term
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D003943	Diagnostic Techniques, Neurological

Browse Leaves

Not provided

Browse Branches

Not provided