Alzheimer DiseaseNCT01815112
Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging
A study testing Magnetic resonance imaging and Positron emission tomography in people with Alzheimer Disease and Mild Cognitive Impairment, run by Centre Hospitalier Universitaire, Amiens at 2 sites in France.
Trial summary
The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia
- What is being tested?
- Magnetic resonance imaging and Positron emission tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Feb 2008to Apr 2014
- 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
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age: over 65
- Participants (or representatives) gave their written informed consent
- Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria
- For Alzheimer arm: probable Alzheimer based disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association ) criteria
- For vascular dementia: diagnosis based on NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences) criteria
- For MCI: diagnosis based on Petersen index
Who cannot join
- Claustrophobia
- Diabetes
- Cardiovascular disease
- Glycemia over 1.3 g/L
- Lumbar puncture within one week before MRI examination
- Non MR-compatible implant
- Suspected brain metastases
- No informed consent signature
Trial locations and contacts
2 sites in 1 country.
France2 sites
CHU Amiens
Amiens, Picardie, 80054
CHU Rouen
Rouen, Haute Normandie, 76000
About this study
Official title: Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia
The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia.
In AD the investigators observe:
Read more
- A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter.
- A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.
Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities:
- Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain
- Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus.
The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.
- Being tested
- Magnetic resonance imaging, Positron emission tomography
- Keywords
- Neurodegenerative disease, Elderly, Dementia, FDG-PET, MRI, Neuroimaging
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction, Dementia, Vascular, Neurodegenerative Diseases, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance imagingOther
Also called Flow MRI, Brain MRI, Diffusion weighted imaging
CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
Positron emission tomographyOther
Also called Dynamic PET imaging
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
| Study group | Role | What they receive |
|---|---|---|
| Alzheimer | Experimental | Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations. Receives: Other: Magnetic resonance imaging; Other: Positron emission tomography |
| Vascular dementia | Experimental | Vascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations. Receives: Other: Magnetic resonance imaging; Other: Positron emission tomography |
| Mild cognitive impairment (MCI) | Experimental | Mild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations. Receives: Other: Magnetic resonance imaging; Other: Positron emission tomography |
| Healthy subjects (MRI) | Experimental | Healthy subjects agreeing to undergo magnetic resonance imaging examination. Receives: Other: Magnetic resonance imaging |
| Healthy subjects (PET) | Experimental | Cognitively healthy subjects. These subjects are people addressed in the nuclear medicine department for cancer-related positron emission tomography examination. If they agree, an extended neuropsychological test will assess that they do not suffer any cognitive disorder. Receives: Other: Positron emission tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dynamic FDG (fluoro-deoxyglucose) PET
Extraction of tissue time-activity curves ; notably in choroid plexus.
Measured: Day 2
Secondary outcomes (3)
Aqueductal CSF flow
Measurement of CSF flow at the Sylvius' aqueduct level. Calculation of the corresponding stroke volume.
Measured: Day 1
Follow-up MRI
MRI examination of MCI patients after one year in order to assess CSF flow differences in MCI how converted to Alzheimer.
Measured: Day 365
Follow-up PET
Dynamic FDG PET examination of MCI patients after one year in order to assess FDG dynamic evolution in MCI how converted to Alzheimer.
Measured: Day 366
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2013 (estimated)
- Study startFeb 2008
- Primary completionApr 2013
- Study completionApr 2014
Why it stopped: Administrative re-organization of the department. Referent physician left the hospital.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc-Etienne MEYER, MD,PhD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01815112
- Sponsor's protocol ID
- PI07-PR-MEYER1
- Other IDs
- 2007-A01009-44
- Status last verified
- Feb 2015
- First submitted
- 18 Mar 2013
- Last updated
- 10 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia
- ClinicalTrials.gov ID
- NCT01815112
- Acronym / sponsor ID
- PI07-PR-MEYER1
- Keywords
- Neurodegenerative disease, Elderly, Dementia, FDG-PET, MRI, Neuroimaging
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Administrative re-organization of the department. Referent physician left the hospital.
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 20 Mar 2013 (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.
The physio-pathology of Alzheimer's disease (AD) remains unknown and there is no cure. Thus, the search for objective markers of preclinical first signs of cognitive impairment, is currently a major public health issue. Early detection of the disease is a major challenge to hope to slow or even stop the neurodegenerative process before the stage of dementia.
In AD the investigators observe:
- A reduction in the volume of brain hippocampi associated with an alteration of the diffusion of water molecules in the white matter.
- A structural brain degeneration coupled with a decrease in cerebral glucose metabolism.
Recent publications show that cerebrospinal fluid (CSF)flow is also altered, probably due to dysfunction of the choroid plexus. Hence the potential interest to study is, in addition to conventional imaging, the imaging of CSF dynamics and choroid plexus metabolism. In that aim,the investigators use two imaging modalities:
- Magnetic resonance imaging (MRI) is used to assess blood and CSF flow in the brain
- Positron emission tomography (PET) is used to assess glucose metabolism in grey/white matter and also in choroid plexus.
The investigators expect that, because of choroid plexus atrophy in AD, CSF flow would be altered as well as glucose metabolism dynamic in choroid plexus.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Alzheimer | Experimental | Other: Magnetic resonance imaging, Other: Positron emission tomographyAlzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations. |
| Vascular dementia | Experimental | Other: Magnetic resonance imaging, Other: Positron emission tomographyVascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations. |
| Mild cognitive impairment (MCI) | Experimental | Other: Magnetic resonance imaging, Other: Positron emission tomographyMild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations. |
| Healthy subjects (MRI) | Experimental | Other: Magnetic resonance imagingHealthy subjects agreeing to undergo magnetic resonance imaging examination. |
| Healthy subjects (PET) | Experimental | Other: Positron emission tomographyCognitively healthy subjects. These subjects are people addressed in the nuclear medicine department for cancer-related positron emission tomography examination. If they agree, an extended neuropsychological test will assess that they do not suffer any cognitive disorder. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Age: over 65
- Participants (or representatives) gave their written informed consent
- Dementia diagnosed according to Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria
- For Alzheimer arm: probable Alzheimer based disease according to NINCDS-ADRDA (National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association ) criteria
- For vascular dementia: diagnosis based on NINDS-AIREN (National Institute of Neurological Disorders and Stroke and Association Internationale pour la Recherche et l'Enseignement en Neurosciences) criteria
Key exclusion criteria (8 listed)
- Claustrophobia
- Diabetes
- Cardiovascular disease
- Glycemia over 1.3 g/L
- Lumbar puncture within one week before MRI examination
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 |
|---|---|---|
| Magnetic resonance imagingAlso: Flow MRI, Brain MRI, Diffusion weighted imagingCSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus. | Other | Alzheimer, Healthy subjects (MRI), Mild cognitive impairment (MCI), Vascular dementia |
| Positron emission tomographyAlso: Dynamic PET imagingTissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus. | Other | Alzheimer, Healthy subjects (PET), Mild cognitive impairment (MCI), Vascular dementia |
Primary outcome
Dynamic FDG (fluoro-deoxyglucose) PET
Time frame: Day 2
Extraction of tissue time-activity curves ; notably in choroid plexus.
3 secondary outcomes
Aqueductal CSF flow
Time frame: Day 1
Follow-up MRI
Time frame: Day 365
Follow-up PET
Time frame: Day 366
Results and safety
The study was stopped early (reason given: Administrative re-organization of the department. Referent physician left the hospital.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2015.
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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.
Marc-Etienne MEYER, MD,PhD principal investigator
CHU Amiens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Magnetic resonance imaging and Positron emission tomography in people with Alzheimer Disease and Mild Cognitive Impairment, run by Centre Hospitalier Universitaire, Amiens at 2 sites 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 6 inclusion and 8 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: stopped early, as of the sponsor's last update on 10 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 was stopped early (reason given: Administrative re-organization of the department. Referent physician left the hospital.). Results are not available in the source record.
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?
Dynamic FDG (fluoro-deoxyglucose) PET (time frame: Day 2). 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 10 Mar 2015.