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

Primary Purpose

Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Magnetic resonance imaging
Positron emission tomography
Sponsored by
Centre Hospitalier Universitaire, Amiens
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer Disease focused on measuring Neurodegenerative disease, Elderly, Dementia, FDG-PET, MRI, Neuroimaging

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Rouen
  • CHU Amiens

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Alzheimer

Vascular dementia

Mild cognitive impairment (MCI)

Healthy subjects (MRI)

Healthy subjects (PET)

Arm Description

Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.

Vascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.

Mild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.

Healthy subjects agreeing to undergo magnetic resonance imaging examination.

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.

Outcomes

Primary Outcome Measures

Dynamic FDG (fluoro-deoxyglucose) PET
Extraction of tissue time-activity curves ; notably in choroid plexus.

Secondary Outcome Measures

Aqueductal CSF flow
Measurement of CSF flow at the Sylvius' aqueduct level. Calculation of the corresponding stroke volume.
Follow-up MRI
MRI examination of MCI patients after one year in order to assess CSF flow differences in MCI how converted to Alzheimer.
Follow-up PET
Dynamic FDG PET examination of MCI patients after one year in order to assess FDG dynamic evolution in MCI how converted to Alzheimer.

Full Information

First Posted
March 18, 2013
Last Updated
March 9, 2015
Sponsor
Centre Hospitalier Universitaire, Amiens
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1. Study Identification

Unique Protocol Identification Number
NCT01815112
Brief Title
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

2. Study Status

Record Verification Date
February 2015
Overall Recruitment Status
Terminated
Why Stopped
Administrative re-organization of the department. Referent physician left the hospital.
Study Start Date
February 2008 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire, Amiens

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Mild Cognitive Impairment, Vascular Dementia
Keywords
Neurodegenerative disease, Elderly, Dementia, FDG-PET, MRI, Neuroimaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Alzheimer
Arm Type
Experimental
Arm Description
Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.
Arm Title
Vascular dementia
Arm Type
Experimental
Arm Description
Vascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.
Arm Title
Mild cognitive impairment (MCI)
Arm Type
Experimental
Arm Description
Mild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.
Arm Title
Healthy subjects (MRI)
Arm Type
Experimental
Arm Description
Healthy subjects agreeing to undergo magnetic resonance imaging examination.
Arm Title
Healthy subjects (PET)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Magnetic resonance imaging
Other Intervention Name(s)
Flow MRI, Brain MRI, Diffusion weighted imaging
Intervention Description
CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.
Intervention Type
Other
Intervention Name(s)
Positron emission tomography
Other Intervention Name(s)
Dynamic PET imaging
Intervention Description
Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.
Primary Outcome Measure Information:
Title
Dynamic FDG (fluoro-deoxyglucose) PET
Description
Extraction of tissue time-activity curves ; notably in choroid plexus.
Time Frame
Day 2
Secondary Outcome Measure Information:
Title
Aqueductal CSF flow
Description
Measurement of CSF flow at the Sylvius' aqueduct level. Calculation of the corresponding stroke volume.
Time Frame
Day 1
Title
Follow-up MRI
Description
MRI examination of MCI patients after one year in order to assess CSF flow differences in MCI how converted to Alzheimer.
Time Frame
Day 365
Title
Follow-up PET
Description
Dynamic FDG PET examination of MCI patients after one year in order to assess FDG dynamic evolution in MCI how converted to Alzheimer.
Time Frame
Day 366

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marc-Etienne MEYER, MD,PhD
Organizational Affiliation
CHU Amiens
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rouen
City
Rouen
State/Province
Haute Normandie
ZIP/Postal Code
76000
Country
France
Facility Name
CHU Amiens
City
Amiens
State/Province
Picardie
ZIP/Postal Code
80054
Country
France

12. IPD Sharing Statement

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

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