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

This study has suspended participant recruitment.
(Administrative re-organization of the geriatric department. Referent physician left the hospital and is still not replaced.)
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT01815112
First received: March 18, 2013
Last updated: February 14, 2014
Last verified: March 2013
  Purpose

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.


Condition Intervention
Alzheimer Disease
Mild Cognitive Impairment
Vascular Dementia
Other: Magnetic resonance imaging
Other: Positron emission tomography

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
Official Title: Benefit of MRI and 18F-FDG PET Imaging in the Early Diagnosis of Alzheimer-like Dementia

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire, Amiens:

Primary Outcome Measures:
  • Dynamic FDG (fluoro-deoxyglucose) PET [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
    Extraction of tissue time-activity curves ; notably in choroid plexus.


Secondary Outcome Measures:
  • Aqueductal CSF flow [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    Measurement of CSF flow at the Sylvius' aqueduct level. Calculation of the corresponding stroke volume.

  • Follow-up MRI [ Time Frame: Day 365 ] [ Designated as safety issue: No ]
    MRI examination of MCI patients after one year in order to assess CSF flow differences in MCI how converted to Alzheimer.

  • Follow-up PET [ Time Frame: Day 366 ] [ Designated as safety issue: No ]
    Dynamic FDG PET examination of MCI patients after one year in order to assess FDG dynamic evolution in MCI how converted to Alzheimer.


Estimated Enrollment: 350
Study Start Date: February 2008
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Flow MRI
  • Brain MRI
  • Diffusion weighted imaging
Other: Positron emission tomography
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Other Name: 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:
  • Flow MRI
  • Brain MRI
  • Diffusion weighted imaging
Other: Positron emission tomography
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Other Name: 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:
  • Flow MRI
  • Brain MRI
  • Diffusion weighted imaging
Other: Positron emission tomography
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Other Name: 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:
  • Flow MRI
  • Brain 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 Name: Dynamic PET imaging

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01815112

Locations
France
CHU Rouen
Rouen, Haute Normandie, France, 76000
CHU Amiens
Amiens, Picardie, France, 80054
Sponsors and Collaborators
Centre Hospitalier Universitaire, Amiens
Investigators
Principal Investigator: Marc-Etienne MEYER, MD,PhD CHU Amiens
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier: NCT01815112     History of Changes
Other Study ID Numbers: PI07-PR-MEYER1, 2007-A01009-44
Study First Received: March 18, 2013
Last Updated: February 14, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Centre Hospitalier Universitaire, Amiens:
Neurodegenerative disease
Elderly
Dementia
FDG-PET
MRI
Neuroimaging

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Dementia, Vascular
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 25, 2014