Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test

August 12, 2010 updated by: Orasi Medical, Inc.

Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: AD Template Development Study

This study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test is useful for diagnosing Probable Alzheimer's Disease according to standard criteria. Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects will be evaluated for symptoms of Alzheimer's Disease and those meeting inclusion criteria will undergo a brief, non-invasive scan of brain function using a magnetoencephalography (MEG). The scan itself lasts 1 minute while the subject is asked to stare at a dot projected in front of them on a video screen. Orasi Medical believes that patterns of brain activity measured at rest are indicative of Alzheimer's Disease pathology.

The protocol is amended to add a follow-up assessment for previously enrolled and completed subjects who agree to participate in the follow-up assessment approximately 9 - 15 months after initial study enrollment. Subjects who agree to participate in the follow-up assessment will undergo the same standardized tests and MEG scan procedure as completed in the initial study.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55419
        • Veterans Affairs Medical Center (Brain Science Center)
      • Minneapolis, Minnesota, United States, 55419
        • Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center)
      • Plymouth, Minnesota, United States, 55441
        • Noran Neurology Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.

Description

Inclusion Criteria:

  1. Subject is between 18 and 90 years of age
  2. i. Provide written informed consent for study participation, OR ii. Provide written assent to study participant accompanied by the provision of written informed by the subject's legally authorized representative (LAR); see Section 8. Informed Consent for details of the procedures use to meet these study inclusion criteria

  3. Have one of the following clinical diagnoses or conditions:

    • Probable AD according to the NINCDS-ADRDA criteria
    • Possible AD according to the NINCDS-ADRDA criteria
    • Prodromal AD according to criteria described by Dubois & Albert (2004)
    • Normal control subject

Exclusion Criteria:

  1. Have a significant non-AD neurological condition including Parkinson's Disease, Vascular Dementia, Lewy Body Dementia or Frontal Temporal Dementia, human immunodeficiency virus, multiple sclerosis, epilepsy, or severe traumatic brain injury.
  2. Have dementia due to multiple etiologies (e.g. mixed dementia)
  3. Show the presence of prominent disturbances in gait thought to be associated with Parkinsonism.
  4. Show prominent changes in personality or social conduct prior to the onset of prominent cognitive dysfunction
  5. Have a Modified Hachinski Ischemia Scale score of greater than 4
  6. Have a history of primary psychotic disorder (e.g schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder
  7. Have a lifetime or current history of alcohol or substance abuse/dependence
  8. Have had an MRI two weeks prior to completing the MEG scan
  9. Have metal braces or pacemaker that may interfere with the MEG scan
  10. Are unable to complete the MEG scan procedure

Follow-up Assessment Inclusion Criteria:

Subjects who completed Protocol ADG 08-01 will be contacted and invited to participate in the follow-up assessment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients diagnosed with Alzheimer's Disease
2
Aged-matched normal controls

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.
Time Frame: Immediately
Immediately

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orasi Medical, Inc.

Collaborators

Minneapolis Veterans Affairs Medical Center
Noran Neurological Clinic

Investigators

  • Principal Investigator: Todd A Verdoorn, Ph.D., Orasi Medical, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

April 23, 2008

First Submitted That Met QC Criteria

April 24, 2008

First Posted (Estimate)

April 25, 2008

Study Record Updates

Last Update Posted (Estimate)

August 13, 2010

Last Update Submitted That Met QC Criteria

August 12, 2010

Last Verified

August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADG-08-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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