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

Sponsor

Centre Hospitalier Universitaire, Amiens (Other)

Overall Status

Terminated

CT.gov ID

NCT01815112

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease Mild Cognitive Impairment Vascular Dementia	Other: Magnetic resonance imaging Other: Positron emission tomography	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

Single (Investigator)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Feb 1, 2008

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Apr 1, 2014

Arms and Interventions

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: 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 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: 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 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: 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 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: 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 Names: Dynamic PET imaging

Outcome Measures

Primary Outcome Measures

Dynamic FDG (fluoro-deoxyglucose) PET [Day 2]
Extraction of tissue time-activity curves ; notably in choroid plexus.

Secondary Outcome Measures

Aqueductal CSF flow [Day 1]
Measurement of CSF flow at the Sylvius' aqueduct level. Calculation of the corresponding stroke volume.
Follow-up MRI [Day 365]
MRI examination of MCI patients after one year in order to assess CSF flow differences in MCI how converted to Alzheimer.
Follow-up PET [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years and Older

Sexes Eligible for Study:

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