Early Diagnosis of Alzheimer-like Dementia: Benefit of MRI and PET Imaging

March 9, 2015 updated by: Centre Hospitalier Universitaire, Amiens

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:

  • 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 Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Haute Normandie
      • Rouen, Haute Normandie, France, 76000
        • CHU Rouen
    • Picardie
      • Amiens, Picardie, France, 80054
        • CHU Amiens

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Alzheimer
Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.
Other: Magnetic resonance imaging
CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
Other Names:
  • Brain MRI
  • Flow MRI
  • Diffusion weighted imaging
Other: Positron emission tomography
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Other Names:
  • Dynamic PET imaging
Experimental: Vascular dementia
Vascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.
Other: Magnetic resonance imaging
CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
Other Names:
  • Brain MRI
  • Flow MRI
  • Diffusion weighted imaging
Other: Positron emission tomography
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Other Names:
  • Dynamic PET imaging
Experimental: Mild cognitive impairment (MCI)
Mild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.
Other: Magnetic resonance imaging
CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
Other Names:
  • Brain MRI
  • Flow MRI
  • Diffusion weighted imaging
Other: Positron emission tomography
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Other Names:
  • Dynamic PET imaging
Experimental: Healthy subjects (MRI)
Healthy subjects agreeing to undergo magnetic resonance imaging examination.
Other: Magnetic resonance imaging
CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
Other Names:
  • Brain MRI
  • Flow MRI
  • Diffusion weighted imaging
Experimental: Healthy subjects (PET)
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.
Other: Positron emission tomography
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Other Names:
  • Dynamic PET imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dynamic FDG (fluoro-deoxyglucose) PET
Time Frame: Day 2
Extraction of tissue time-activity curves ; notably in choroid plexus.
Day 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aqueductal CSF flow
Time Frame: Day 1
Measurement of CSF flow at the Sylvius' aqueduct level. Calculation of the corresponding stroke volume.
Day 1
Follow-up MRI
Time Frame: Day 365
MRI examination of MCI patients after one year in order to assess CSF flow differences in MCI how converted to Alzheimer.
Day 365
Follow-up PET
Time Frame: Day 366
Dynamic FDG PET examination of MCI patients after one year in order to assess FDG dynamic evolution in MCI how converted to Alzheimer.
Day 366

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire, Amiens

Investigators

  • Principal Investigator: Marc-Etienne MEYER, MD,PhD, CHU Amiens

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

March 18, 2013

First Submitted That Met QC Criteria

March 19, 2013

First Posted (Estimate)

March 20, 2013

Study Record Updates

Last Update Posted (Estimate)

March 10, 2015

Last Update Submitted That Met QC Criteria

March 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PI07-PR-MEYER1
  • 2007-A01009-44 (Registry Identifier: RCB)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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