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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01815112
• Other study ID #: PI07-PR-MEYER1
• Secondary ID: 2007-A01009-44
• Status: Terminated
• Phase: N/A
• First received: March 18, 2013
• Last updated: March 9, 2015
• Start date: February 2008
• Est. completion date: April 2014

Study information

• Verified date: February 2015
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. completion date: April 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognition Disorders
• Dementia
• Dementia, Vascular
• Mild Cognitive Impairment
• Vascular Dementia

Intervention

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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens	Picardie
France	CHU Rouen	Rouen	Haute Normandie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dynamic FDG (fluoro-deoxyglucose) PET	Extraction of tissue time-activity curves ; notably in choroid plexus.	Day 2	No
Secondary	Aqueductal CSF flow	Measurement of CSF flow at the Sylvius' aqueduct level. Calculation of the corresponding stroke volume.	Day 1	No
Secondary	Follow-up MRI	MRI examination of MCI patients after one year in order to assess CSF flow differences in MCI how converted to Alzheimer.	Day 365	No
Secondary	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.	Day 366	No