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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00412048
• Other study ID #: 3659
• Status: Withdrawn
• Phase: N/A
• First received: December 14, 2006
• Last updated: November 12, 2012
• Start date: April 2012
• Est. completion date: February 2018

Study information

• Verified date: November 2012
• Source: University Hospital, Strasbourg, France
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 55 Years to 75 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects		1, 5 years	No
Secondary	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	No