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Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study (AMIMAGE 2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01582919
First received: April 20, 2012
Last updated: January 12, 2015
Last verified: January 2015
  Purpose
It is now acknowledged that Alzheimer's disease is characterized by a long period of pathophysiological change. Developing new strategies to achieve diagnoses as early as possible has become a major goal for therapies aimed at slowing the progression of this disease. While diagnoses currently rely principally on clinical neuropsychology, the typical diagnostic criteria of NINCDS-ADRDA are inapplicable in the early stage of the disease. The goal of our project is to identify very early imaging markers for Alzheimer's disease among patients with no report of cognitive difficulties. In order to achieve this goal, we propose a longitudinal study in an elderly population cohort.

Condition Intervention
Dementia
Alzheimer Disease
Other: Neuroimaging

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: STUDY OF IMAGING MARKERS IN THE VERY EARLY STAGES OF DEMENTIA AMONG RETIRED RURAL FARM IN THE GIRONDE AND PARTICIPATING IN THE AMI COHORT EPIDEMIOLOGY: A LONGITUDINAL STUDY.

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex) [ Time Frame: Inclusion (Day 0) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Performance on neuropsychological and daily life cognitive tests [ Time Frame: Everyday up to Day 7 after inclusion ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: September 2012
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Participant from AMI cohort Other: Neuroimaging
Active Comparator: Participant from 3Ccohort Other: Neuroimaging

Detailed Description:
The AMImage2 project that follows AMImage1 and MRI-3C consists of an imaging study in association with longitudinal epidemiologic cohorts (AMI and 3C). The first objective is to investigate the association between the evolution of imaging markers and the evolution of cognitive performance in normal and pathological aging. This objective will be conducted among subjects having already participated in AMImage1, thereby permitting the longitudinal study of MRI data. An MRI exam will also be proposed to 100 subjects (members of the AMI and 3C cohorts) in order to provide a third wave of MRI (for a longer-term MRI follow-up) or a second one for the participants who only had one MRI exam in the AMImage project. Our second objective is cross-sectional and will study the imaging parameters of subjects presenting signs of cognitive decline over the previous 4 years (through the follow-up conducted in the AMI cohort). Finally, an additional objective will consist in a comparison between two populations very contrasted in terms of cognitive reserve: AMI (very low education level in rural area) and 3C (higher level of education in urban area).
  Eligibility

Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 65 years old
  • Be retired from agricultural profession
  • live in rural area in Gironde (France)

Exclusion Criteria:

  • Lefthanded
  • having a dementia (MMSE < 13)
  • Having a vascular cerebral accident
  • Parkinson disease
  • RMI exclusion criteria
  • [18F]-FDG PET SCAN exclusion criteria
  • Poor health condition does not allowing transport to neuroimaging service
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01582919

Contacts
Contact: Michèle ALLARD, Pr michele.allard@chu-bordeaux.fr

Locations
France
Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux Recruiting
Bordeaux, France, 33000
Contact: Michèle ALLARD, Pr       michele.allard@chu-bordeaux.fr   
Principal Investigator: Michèle ALLARD, Pr         
Sub-Investigator: Jean-François DARTIGUES, Pr         
Sub-Investigator: Philippe FERNANDEZ, Dr         
Sub-Investigator: Igor SIBON, Dr         
Sub-Investigator: Alexandra FOUBERT, Dr         
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
Principal Investigator: Michèle ALLARD, Pr Bordeaux University Hospital
  More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01582919     History of Changes
Other Study ID Numbers: CHUBX 2011/15 
Study First Received: April 20, 2012
Last Updated: January 12, 2015
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
Neurocognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on December 02, 2016