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Clinical Trials/NCT01815112
NCT01815112TerminatedNot Applicable

Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia

Centre Hospitalier Universitaire, Amiens4 sites in 1 country60 target enrollmentStarted: February 2008Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
60
Locations
4
Primary Endpoint
Dynamic FDG (fluoro-deoxyglucose) PET

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Diagnostic
Masking
Single (Investigator)

Eligibility Criteria

Ages
65 Years to — (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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
  • 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

Outcomes

Primary Outcomes

Dynamic FDG (fluoro-deoxyglucose) PET

Time Frame: Day 2

Extraction of tissue time-activity curves ; notably in choroid plexus.

Secondary Outcomes

  • Aqueductal CSF flow(Day 1)
  • Follow-up MRI(Day 365)
  • Follow-up PET(Day 366)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (4)

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