Clinical trial NCT01582919: Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study
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
Overall status: COMPLETED
Phase: NA
Conditions: Dementia
Alzheimer Disease
Keywords: dementia
Alzheimer's Disease
diagnostic
biomarkers
neuroimaging
PET
MRI
mild cognitive impairment
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2012-04-23
Enrollment: 304
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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

Primary outcomes:
measure: Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex)
timeFrame: Inclusion (Day 0)
Secondary outcomes:
measure: Performance on neuropsychological and daily life cognitive tests
timeFrame: Everyday up to Day 7 after inclusion
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Michèle ALLARD, Pr
role: PRINCIPAL_INVESTIGATOR
References: