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

NCT ID: NCT01815112

Last Updated: 2015-03-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2014-04-30

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.

Conditions

Alzheimer Disease; Mild Cognitive Impairment; Vascular Dementia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Alzheimer

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

Group Type: EXPERIMENTAL

Magnetic resonance imaging

Intervention Type: OTHER

CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.

Positron emission tomography

Intervention Type: OTHER

Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.

Vascular dementia

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

Group Type: EXPERIMENTAL

Magnetic resonance imaging

Intervention Type: OTHER

CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.

Positron emission tomography

Intervention Type: OTHER

Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.

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.

Group Type: EXPERIMENTAL

Magnetic resonance imaging

Intervention Type: OTHER

CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.

Positron emission tomography

Intervention Type: OTHER

Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.

Healthy subjects (MRI)

Healthy subjects agreeing to undergo magnetic resonance imaging examination.

Group Type: EXPERIMENTAL

Magnetic resonance imaging

Intervention Type: OTHER

CSF flow measurement at Sylvius' aqueduct and cervical levels. Apparent diffusion coefficient and fractional anisotropy determination in corpus callosum, cingulum and hippocampus.

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.

Group Type: EXPERIMENTAL

Positron emission tomography

Intervention Type: OTHER

Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.

Interventions

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.

Intervention Type: OTHER

Positron emission tomography

Tissue-time activity curves in hippocampus, cingulum, medio-temporal cortex and choroid plexus.

Intervention Type: OTHER

Other Intervention Names

Flow MRI; Brain MRI; Diffusion weighted imaging; Dynamic PET imaging

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Marc-Etienne MEYER, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

CHU Amiens

Locations

CHU Rouen

Rouen, Haute Normandie, France

CHU Amiens

Amiens, Picardie, France

Countries

France

Other Identifiers

2007-A01009-44

Identifier Type: REGISTRY

Identifier Source: secondary_id

PI07-PR-MEYER1

Identifier Type: -

Identifier Source: org_study_id