DementiaAMIMAGENCT00951197
Evaluation of Alteration by Magnetic Resonance Imaging (MRI) in Dementia Among Elderly Subjects
An observational study of Dementia and Alzheimer Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as diagnostic standards in research. 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
- How many people
- 318 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2009to Mar 2011
- Phase
- Observational
- 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
Study population: population retired from agricultural profession and living in rural area in Gironde
Who may be able to join
- participate in the AMI cohort
- be aged 65 and older
- be retired from agricultural profession
- live in rural area in Gironde
Who cannot join
- contraindication of MRI
- left-handed
- severe dementia
- Parkinson's disease
- poor health incompatible with the transport to neuroimaging service
- to be left handed
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Estimation of Microstructure Alteration by MRI in Dementia Among Elderly Subjects Retired From Agricultural Profession and Living in Rural Area in Gironde - Participants From the AMI Cohort.
Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as diagnostic standards in research. However, the research on AD progresses and some biomarkers have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance Imaging (MRI).
- 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
Three successive MRI acquisitions to measure FA, MTR and T2 parameters.
| Study group | Role | What they receive |
|---|---|---|
| elderly subjects retired from agriculture | Not described Receives: Other: Neuroimaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
FA (Fractional Anisotropy), MTR (magnetization transfer ratio) and T2 (Transverse relaxation time) measures in patients with dementia compared to controls, in left and right hippocampus, and posterior cingulum
Measured: day 0
Secondary outcomes (3)
FA, MTR and T2 measures in subjects with mild cognitive impairment no dementia
Measured: day 0
Performances in the 7 neuropsychological tests available in the AMI cohort
Measured: day 0
FA measures for the connexion Hippocampus-cingulum posterior
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startApr 2009
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 318 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michèle ALLARD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951197
- Sponsor's protocol ID
- CHUBX2008/13
- Acronym
- AMIMAGE
- Status last verified
- Apr 2012
- First submitted
- 22 Apr 2009
- Last updated
- 30 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimation of Microstructure Alteration by MRI in Dementia Among Elderly Subjects Retired From Agricultural Profession and Living in Rural Area in Gironde - Participants From the AMI Cohort.
- ClinicalTrials.gov ID
- NCT00951197
- Acronym / sponsor ID
- AMIMAGE / CHUBX2008/13
- Conditions
- Dementia, Alzheimer Disease
- Keywords
- dementia, Alzheimer's Disease, diagnostic, biomarkers, neuroimaging, PET, MRI, mild cognitive impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 318 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 4 Aug 2009 (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.
Capturing the earliest stages of Dementia especially Alzheimer's Disease (AD) is a great challenge. Until now the NINCDS-ADRDA and the DSM criteria for AD were largely used as diagnostic standards in research. However, the research on AD progresses and some biomarkers have been recently suggested to improve the diagnostic criteria of AD, such as cerebrospinal fluid markers, neuroimaging with Positon Emission Tomography (PET) or Magnetic Resonance Imaging (MRI).
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly subjects retired from agriculture | – | Other: Neuroimaging |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- population retired from agricultural profession and living in rural area in Gironde
Key inclusion criteria (4 listed)
- participate in the AMI cohort
- be aged 65 and older
- be retired from agricultural profession
- live in rural area in Gironde
Key exclusion criteria (6 listed)
- contraindication of MRI
- left-handed
- severe dementia
- Parkinson's disease
- poor health incompatible with the transport to neuroimaging service
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 |
|---|---|---|
| NeuroimagingThree successive MRI acquisitions to measure FA, MTR and T2 parameters. | Other | elderly subjects retired from agriculture |
Primary outcome
FA (Fractional Anisotropy), MTR (magnetization transfer ratio) and T2 (Transverse relaxation time) measures in patients with dementia compared to controls, in left and right hippocampus, and posterior cingulum
Time frame: day 0
3 secondary outcomes
FA, MTR and T2 measures in subjects with mild cognitive impairment no dementia
Time frame: day 0
Performances in the 7 neuropsychological tests available in the AMI cohort
Time frame: day 0
FA measures for the connexion Hippocampus-cingulum posterior
Time frame: day 0
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 30 Apr 2012.
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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 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?
An observational study of 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 4 inclusion and 6 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 30 Apr 2012. 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?
FA (Fractional Anisotropy), MTR (magnetization transfer ratio) and T2 (Transverse relaxation time) measures in patients with dementia compared to controls, in left and right hippocampus, and posterior cingulum (time frame: day 0). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2012.