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

Not Applicable

Terminated

• Conditions: Vascular Dementia; Mild Cognitive Impairment; Alzheimer Disease
• Interventions: Other: Magnetic resonance imaging; Other: Positron emission tomography

• Registration Number: NCT01815112
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2013-03-18
• Study First Submitted QC: 2013-03-19
• Study First Posted: 2013-03-20
• Primary Completion: 2013-04
• Study Completion: 2014-04
• Status Verified: 2015-02
• Last Update Submitted: 2015-03-09
• Last Update Posted: 2015-03-10

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Alzheimer	Magnetic resonance imaging	Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.
Alzheimer	Positron emission tomography	Alzheimer patients detected via conventional clinical and neuropsychological tests. They will undergo Magnetic resonance imaging and positron emission tomography examinations.
Vascular dementia	Positron emission tomography	Vascular dementia patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.
Healthy subjects (MRI)	Magnetic resonance imaging	Healthy subjects agreeing to undergo magnetic resonance imaging examination.
Vascular dementia	Magnetic resonance imaging	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)	Magnetic resonance imaging	Mild cognitive impairment (MCI) patients detected via conventional clinical and neuropsychological tests. They will undergo magnetic resonance imaging and positron emission tomography examinations.
Mild cognitive impairment (MCI)	Positron emission tomography	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 (PET)	Positron emission tomography	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

CHU Rouen; 🇫🇷 Rouen, Haute Normandie, France

CHU Amiens; 🇫🇷 Amiens, Picardie, France