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

This study has been completed.
Sponsor:
Collaborators:
Noran Neurological Clinic
Minneapolis Veterans Affairs Medical Center
Information provided by:
Orasi Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00666445
First received: April 23, 2008
Last updated: August 12, 2010
Last verified: August 2010
  Purpose

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.


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: AD Template Development Study

Resource links provided by NLM:


Further study details as provided by Orasi Medical, Inc.:

Primary Outcome Measures:
  • Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease. [ Time Frame: Immediately ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients diagnosed with Alzheimer's Disease
2
Aged-matched normal controls

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00666445

Locations
United States, Minnesota
Veterans Affairs Medical Center (Brain Science Center)
Minneapolis, Minnesota, United States, 55419
Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center)
Minneapolis, Minnesota, United States, 55419
Noran Neurology Clinic
Plymouth, Minnesota, United States, 55441
Sponsors and Collaborators
Orasi Medical, Inc.
Noran Neurological Clinic
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Todd A Verdoorn, Ph.D. Orasi Medical, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Todd Verdoorn, Ph.D., Chief Scientific Officer, Orasi Medical, Inc.
ClinicalTrials.gov Identifier: NCT00666445     History of Changes
Other Study ID Numbers: ADG-08-01
Study First Received: April 23, 2008
Last Updated: August 12, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Orasi Medical, Inc.:
Alzheimer's Disease
Diagnosis
Neuronal function
Cognitive Impairment
Magnetoencephalography

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 23, 2014