Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study (AMIMAGE 2)
Primary Purpose
Dementia, Alzheimer Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuroimaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Dementia focused on measuring dementia, Alzheimer's Disease, diagnostic, biomarkers, neuroimaging, PET, MRI, mild cognitive impairment
Eligibility 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
Sites / Locations
- Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Participant from AMI cohort
Participant from 3Ccohort
Arm Description
Outcomes
Primary Outcome Measures
Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex)
Secondary Outcome Measures
Performance on neuropsychological and daily life cognitive tests
Full Information
NCT ID
NCT01582919
First Posted
April 20, 2012
Last Updated
March 31, 2017
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT01582919
Brief Title
Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study
Acronym
AMIMAGE 2
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2012 (Actual)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer Disease
Keywords
dementia, Alzheimer's Disease, diagnostic, biomarkers, neuroimaging, PET, MRI, mild cognitive impairment
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
304 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Participant from AMI cohort
Arm Type
Experimental
Arm Title
Participant from 3Ccohort
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Neuroimaging
Primary Outcome Measure Information:
Title
Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex)
Time Frame
Inclusion (Day 0)
Secondary Outcome Measure Information:
Title
Performance on neuropsychological and daily life cognitive tests
Time Frame
Everyday up to Day 7 after inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michèle ALLARD, Pr
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux
City
Bordeaux
ZIP/Postal Code
33000
Country
France
12. IPD Sharing Statement
Learn more about this trial
Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study
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