Neuroimaging Markers of Alzheimer Disease: a Longitudinal... | NCT01582919

Studies
Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study

NCT01582919

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

May 14, 2026Actual

Enrollment

304Actual

Phase

Not Applicable

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

ID	Type	Description	Link
2011-A01393-38	Other Identifier	ANSM

Status Module

Record Verification Date

Mar 2017

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

Sep 2012Actual

Primary Completion Date

Jun 2015Actual

Completion Date

Jun 2015Actual

First Submitted Date

Apr 20, 2012

First Submission Date that Met QC Criteria

Apr 20, 2012

First Posted Date

Apr 23, 2012Estimated

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

May 11, 2026

Last Update Posted Date

May 14, 2026Actual

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

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).

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

304Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Participant from AMI cohort	Experimental		Other: Neuroimaging
Participant from 3Ccohort	Active Comparator		Other: Neuroimaging

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neuroimaging	Other		Participant from 3Ccohort Participant from AMI cohort

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
Performance on neuropsychological and daily life cognitive tests		Everyday up to Day 7 after inclusion

Other Outcomes

Not provided

Eligibility Module

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

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Michèle ALLARD, Pr	University Hospital, Bordeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Pellegrin - C.H.U. de Bordeaux		Bordeaux		33000	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27539327	Result	Schweitzer P, Husky M, Allard M, Amieva H, Peres K, Foubert-Samier A, Dartigues JF, Swendsen J. Feasibility and validity of mobile cognitive testing in the investigation of age-related cognitive decline. Int J Methods Psychiatr Res. 2017 Sep;26(3):e1521. doi: 10.1002/mpr.1521. Epub 2016 Aug 19.
32922282	Result

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

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

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