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

Primary Purpose

Alzheimer's Disease

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
fMRI to detect MCI patients who will convert to Alzheimer's disease
Sponsored by
University Hospital, Strasbourg, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Alzheimer's Disease

Eligibility Criteria

55 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Other

    Other

    Other

    Arm Label

    ALZHEIMER DISEASE

    MOLD COGNITIVE IMPAIRMENT

    CONTROLS

    Arm Description

    Outcomes

    Primary Outcome Measures

    Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects

    Secondary Outcome Measures

    Follow-up of MCI patients at 6, 12 and 18 months to detect a conversion to Alzheimer's disease

    Full Information

    First Posted
    December 14, 2006
    Last Updated
    November 12, 2012
    Sponsor
    University Hospital, Strasbourg, France
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00412048
    Brief Title
    Functional Magnetic Resonance Imaging - Synthetic Aperture Magnetometry (fMRI-SAM) and Alzheimer's Disease
    Official Title
    Evaluation of fMRI-SAM in the Early Detection of Alzheimer's Disease.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    April 2012 (undefined)
    Primary Completion Date
    February 2018 (Anticipated)
    Study Completion Date
    February 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University Hospital, Strasbourg, France

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Alzheimer's Disease

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    ALZHEIMER DISEASE
    Arm Type
    Other
    Arm Title
    MOLD COGNITIVE IMPAIRMENT
    Arm Type
    Other
    Arm Title
    CONTROLS
    Arm Type
    Other
    Intervention Type
    Procedure
    Intervention Name(s)
    fMRI to detect MCI patients who will convert to Alzheimer's disease
    Intervention Description
    There is a fMRI to be realized in the 3 arms. No drug is administered
    Primary Outcome Measure Information:
    Title
    Comparing fMRI data between 3 groups of subjects: MCI, Alzheimer's disease and normal subjects
    Time Frame
    1, 5 years
    Secondary Outcome Measure Information:
    Title
    Follow-up of MCI patients at 6, 12 and 18 months to detect a conversion to Alzheimer's disease
    Time Frame
    Prediction of Alzheimer's disease on fMRI data

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Francois Sellal, MD
    Organizational Affiliation
    Hôpitaux Universitaires de Strasbourg
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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