Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study

Not Applicable

Completed

• Conditions: Alzheimer Disease; Dementia
• Interventions: Other: Neuroimaging

• Registration Number: NCT01582919
• Lead Sponsor: University Hospital, Bordeaux

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).

Study Timeline

• Study First Submitted: 2012-04-20
• Study First Submitted QC: 2012-04-20
• Study First Posted: 2012-04-23
• Study Start: 2012-09
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Participant from AMI cohort	Neuroimaging	-
Participant from 3Ccohort	Neuroimaging	-

Primary Outcome Measures

Name	Time	Method
Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex)	Inclusion (Day 0)

Secondary Outcome Measures

Name	Time	Method
Performance on neuropsychological and daily life cognitive tests	Everyday up to Day 7 after inclusion

Trial Locations

Locations (1)

Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux; 🇫🇷 Bordeaux, France