DementiaAMIMAGE 2NCT01582919
Neuroimaging Markers of Alzheimer Disease: a Longitudinal Population Study
A study testing Neuroimaging in people with Dementia and Alzheimer Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease
- What is being tested?
- Neuroimaging
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2012to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- At least 65 years old
- Be retired from agricultural profession
- live in rural area in Gironde (France)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this 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.
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.
Read the 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).
- Conditions
- Dementia, Alzheimer Disease
- Being tested
- Neuroimaging
- Keywords
- dementia, Alzheimer's Disease, diagnostic, biomarkers, neuroimaging, PET, MRI, mild cognitive impairment
- Medical subject headings
- Dementia, Alzheimer Disease, Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeuroimagingOther
| Study group | Role | What they receive |
|---|---|---|
| Participant from AMI cohort | Experimental | Not described Receives: Other: Neuroimaging |
| Participant from 3Ccohort | Active comparator | Not described Receives: Other: Neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex)
Measured: Inclusion (Day 0)
Secondary outcomes (1)
Performance on neuropsychological and daily life cognitive tests
Measured: Everyday up to Day 7 after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DementiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle ALLARD, Pr, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01582919
- Sponsor's protocol ID
- CHUBX 2011/15
- Other IDs
- 2011-A01393-38
- Acronym
- AMIMAGE 2
- Status last verified
- Mar 2017
- First submitted
- 20 Apr 2012
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 27539327Nicolas R, Hiba B, Dilharreguy B, Barse E, Baillet M, Edde M, Pelletier A, Periot O, Helmer C, Allard M, Dartigues JF, Amieva H, Peres K, Fernandez P, Catheline G. Changes Over Time of Diffusion MRI in the White Matter of Aging Brain, a Good Predictor of Verbal Recall. Front Aging Neurosci. 2020 Aug 14;12:218. doi: 10.3389/fnagi.2020.00218. eCollection 2020.
PubMed 32922282
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01582919
- Acronym / sponsor ID
- AMIMAGE 2 / CHUBX 2011/15
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- dementia, Alzheimer's Disease, diagnostic, biomarkers, neuroimaging, PET, MRI, mild cognitive impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Sep 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 23 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participant from AMI cohort | Experimental | Other: Neuroimaging |
| Participant from 3Ccohort | Active comparator | Other: Neuroimaging |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- At least 65 years old
- Be retired from agricultural profession
- live in rural area in Gironde (France)
Key exclusion criteria (7 listed)
- Lefthanded
- having a dementia (MMSE < 13)
- Having a vascular cerebral accident
- Parkinson disease
- RMI exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroimaging | Other | Participant from 3Ccohort, Participant from AMI cohort |
Primary outcome
Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex)
Time frame: Inclusion (Day 0)
1 secondary outcome
Performance on neuropsychological and daily life cognitive tests
Time frame: Everyday up to Day 7 after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Results publication: PubMed 27539327Schweitzer 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.
- Results publication: PubMed 32922282Nicolas R, Hiba B, Dilharreguy B, Barse E, Baillet M, Edde M, Pelletier A, Periot O, Helmer C, Allard M, Dartigues JF, Amieva H, Peres K, Fernandez P, Catheline G. Changes Over Time of Diffusion MRI in the White Matter of Aging Brain, a Good Predictor of Verbal Recall. Front Aging Neurosci. 2020 Aug 14;12:218. doi: 10.3389/fnagi.2020.00218. eCollection 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michèle ALLARD, Pr principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroimaging in people with Dementia and Alzheimer Disease, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of volume and diffusion parameters in the gray matter (hippocampus and cingular posterior cortex) (time frame: Inclusion (Day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01582919, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.