Suspended

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

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What is being tested

Magnetic resonance imaging

+ Positron emission tomography

+ Magnetic resonance imaging

Other
Who is being recruted

Arterial Occlusive Diseases+17

+ Arteriosclerosis

+ Mental Disorders

Over 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Diagnostic Study

Interventional
Study Start: February 2008
See protocol details

Summary

Principal SponsorCentre Hospitalier Universitaire, Amiens
Last updated: March 10, 2015
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2008

Actual date on which the first participant was enrolled.

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.

NCT01815112
Principal SponsorCentre Hospitalier Universitaire, Amiens
Last updated: March 10, 2015
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

60 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Diagnostic Study

Diagnostic studies focus on improving how we detect or confirm a disease. They test new tools or techniques that could provide faster or more accurate diagnoses.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Arterial Occlusive DiseasesArteriosclerosisMental DisordersBrain DiseasesCardiovascular DiseasesCentral Nervous System DiseasesIntracranial ArteriosclerosisCerebrovascular DisordersCognition DisordersNervous System DiseasesVascular DiseasesNeurocognitive DisordersIntracranial Arterial DiseasesTauopathiesLeukoencephalopathiesAlzheimer DiseaseDementiaDementia, VascularNeurodegenerative DiseasesCognitive Dysfunction

Criteria

6 inclusion criteria required to participate
Age: over 65

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 MCI: diagnosis based on Petersen index

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8 exclusion criteria prevent from participating
Cardiovascular disease

Claustrophobia

Diabetes

Glycemia over 1.3 g/L

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

5 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

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

Group III

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

Group IV

Experimental
Healthy subjects agreeing to undergo magnetic resonance imaging examination.

Group 5

Experimental
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.

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

CHU Rouen

Rouen, FranceOpen CHU Rouen in Google Maps

CHU Amiens

Amiens, France
Suspended2 Study Centers