Clinical trial NCT01815112: Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging
Official title: Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Vascular Dementia
Keywords: Neurodegenerative disease
Elderly
Dementia
FDG-PET
MRI
Neuroimaging
Lead sponsor: Centre Hospitalier Universitaire, Amiens
Sponsor class: OTHER
First posted: 2013-03-20
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Dynamic FDG (fluoro-deoxyglucose) PET
timeFrame: Day 2
Secondary outcomes:
measure: Aqueductal CSF flow
timeFrame: Day 1
measure: Follow-up MRI
timeFrame: Day 365
measure: Follow-up PET
timeFrame: Day 366
Other outcomes:
Locations:
city: Rouen
country: France
facility: CHU Rouen
state: Haute Normandie
city: Amiens
country: France
facility: CHU Amiens
state: Picardie
Study officials:
affiliation: CHU Amiens
name: Marc-Etienne MEYER, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: