Study Stopped
Administrative re-organization of the department. Referent physician left the hospital.
Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging
Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia
2 other identifiers
interventional
60
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable alzheimer-disease
Started Feb 2008
Longer than P75 for not_applicable alzheimer-disease
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 18, 2013
CompletedFirst Posted
Study publicly available on registry
March 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedMarch 10, 2015
February 1, 2015
5.2 years
March 18, 2013
March 9, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Dynamic FDG (fluoro-deoxyglucose) PET
Extraction of tissue time-activity curves ; notably in choroid plexus.
Day 2
Secondary Outcomes (3)
Aqueductal CSF flow
Day 1
Follow-up MRI
Day 365
Follow-up PET
Day 366
Study Arms (5)
Alzheimer
EXPERIMENTALAlzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.
Vascular dementia
EXPERIMENTALVascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.
Mild cognitive impairment (MCI)
EXPERIMENTALMild 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)
EXPERIMENTALHealthy subjects agreeing to undergo magnetic resonance imaging examination.
Healthy subjects (PET)
EXPERIMENTALCognitively 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.
Interventions
CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Rouen
Rouen, Haute Normandie, 76000, France
CHU Amiens
Amiens, Picardie, 80054, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc-Etienne MEYER, MD,PhD
CHU Amiens
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 18, 2013
First Posted
March 20, 2013
Study Start
February 1, 2008
Primary Completion
April 1, 2013
Study Completion
April 1, 2014
Last Updated
March 10, 2015
Record last verified: 2015-02