Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease

Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease.

The aim of the protocol is to study the resting brain activation profile of 3 groups of people, using a new fMRI procedure, called fMRI-SAM. fMRI-SAM will be applied to 25 Alzheimer's disease (AD) patients, 25 patients suffering from amnestic - mild cognitive impairment (MCI) - a clinical picture which may be a prodromal form of AD - and 60 healthy controls. The first analysis of the data will search differences of brain activation profiles between the 3 groups. In the second step, the investigators will study the predictive value of fMRI-SAM to detect MCI patients who will later convert to AD.

Study Overview

• Status: Withdrawn
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Alzheimer's disease of mild to moderate severity (25 patients)
• Amnestic MCI patients (25 patients)
• 55-75 year-old patients

Exclusion criteria:

• Any other cause of dementia for AD patients
• Any stroke
• Any disease with a negative vital prognosis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: ALZHEIMER DISEASE	Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease; There is a fMRI to be realized in the 3 arms. No drug is administered
Other: MOLD COGNITIVE IMPAIRMENT	Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease; There is a fMRI to be realized in the 3 arms. No drug is administered
Other: CONTROLS	Procedure: fMRI to detect MCI patients who will convert to Alzheimer's disease; There is a fMRI to be realized in the 3 arms. No drug is administered

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects	1, 5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Follow-up of MCI patients at 6, 12 and 18 months to detect a conversion to Alzheimer's disease	Prediction of Alzheimer's disease on fMRI data

Collaborators and Investigators

• Sponsor: University Hospital, Strasbourg, France
• Investigators: Principal Investigator: Francois Sellal, MD, Hôpitaux Universitaires de Strasbourg

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Anticipated): February 1, 2018
• Study Completion (Anticipated): February 1, 2018

Study Registration Dates

• First Submitted: December 14, 2006
• First Submitted That Met QC Criteria: December 14, 2006
• First Posted (Estimate): December 15, 2006

Study Record Updates

• Last Update Posted (Estimate): November 14, 2012
• Last Update Submitted That Met QC Criteria: November 12, 2012
• Last Verified: November 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: 3659