Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG)
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Observational

Summary: 
      The current study is intended to enrich and extend the database of Alzheimer's Disease (AD)
      and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for
      dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of
      normal neurological function. This study will include 2 MEG and electroencephalography (EEG)
      scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All
      subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day
      of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects
      will undergo 2 standard functional tests.

      This study will test the following hypotheses:

        -  MEG scans of resting-state, eyes-open brain function reveal patterns of correlated
           activity that differ between HC subjects and subjects diagnosed with dementia of
           Alzheimer's type;

        -  Patterns of correlated activity measured in AD subjects correspond to other measures of
           disease severity such as standard functional test scores;

        -  MEG scan patterns for HC subjects are consistent across repeated measures taken over a
           30 day period.
    

Detailed description: 
      This study is intended to extend the capabilities of the Synchronous Neural Interaction®
      (SNI) test, which is under development by the sponsor, Orasi Medical, Inc.
      Magnetoencephalography (MEG) is an FDA-approved, non-invasive technique used to measure
      magnetic fields generated by small intracellular electrical currents in neurons. The SNI test
      evaluates brain function and dysfunction by analyzing brief (1 minute) MEG scans and
      comparing individual scan results to a database of MEG scans and clinical information.
      Proprietary software algorithms process the data generated by MEG instruments allowing Orasi
      to use the SNI test for accurate tracking and diagnosis of neurological disorders such as
      Alzheimer's disease (AD) and Multiple Sclerosis (MS). The current study is intended to enrich
      and extend the database of AD and healthy control (HC) MEG scans and will include patients
      meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC
      subjects meeting criteria of normal neurological function. This study will include 2 MEG and
      EEG scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All
      subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day
      of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects
      will undergo 2 standard functional tests. The results generated in this study will be used to
      improve the accuracy of the SNI test for diagnosing and tracking the progression of AD. Once
      a robust training set or template is described, Orasi Medical will conduct additional
      clinical studies to formally test the diagnostic accuracy of the technology and support
      applications for regulatory approval to market the SNI test for AD. The objective of this
      work is to produce and validate a novel tracking and diagnostic technology for AD that is
      more selective and sensitive than currently available diagnostic tools.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        The current study will include patients meeting DSM-IV-TR criteria for dementia of
        Alzheimer's type, and age- and gender-matched healthy control subjects meeting criteria of
        normal neurological function.
      
Keywords: Alzheimer's Disease; AD; Healthy Control