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Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test
This study is currently recruiting participants.
Verified by Orasi Medical, Inc., November 2008
First Received: April 23, 2008   Last Updated: November 18, 2008   History of Changes
Sponsors and Collaborators: Orasi Medical, Inc.
University of Colorado at Denver and Health Sciences Center
Radiant Research
Noran Neurology Clinic
Minneapolis Veterans Affairs Medical Center
Information provided by: Orasi Medical, Inc.
ClinicalTrials.gov Identifier: NCT00666445
  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.


Condition
Alzheimer's Disease

Genetics Home Reference related topics: Alzheimer disease
MedlinePlus related topics: Alzheimer's Disease
U.S. FDA Resources
Study Type: Observational
Study Design: Case Control, Cross-Sectional
Official Title: Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: AD Template Development Study

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 ]

Biospecimen Retention:   None Retained

Biospecimen Description:

Estimated Enrollment: 150
Study Start Date: April 2008
Estimated Study Completion Date: August 2009
Estimated Primary Completion Date: July 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, schizhoaffective 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00666445

Contacts
Contact: Timothy J Kappers, MBA, RAC 800-383-9547 ext 107 tim.kappers@orasimedical.com
Contact: Patty Verdoorn, M.S. 800-383-9547 ext 104 patty.verdoorn@orasimedical.com

Locations
United States, Colorado
University of Colorado at Denver and Health Science Center Recruiting
Denver, Colorado, United States, 80262
Contact: Kim Frey, MS     303-363-5155     kim.frey@UCHSC.edu    
Principal Investigator: David Arciniegas, MD            
Radiant Research Clinic Recruiting
Denver, Colorado, United States, 80262
Contact: Huette Thompson, MS     303-480-7135     huettethompson@radiantresearch.com    
Principal Investigator: Leslie Moldauer, MD            
United States, Minnesota
Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center) Recruiting
Minneapolis, Minnesota, United States, 55419
Contact: Lorren Grandle, MS     612-629-7555     lorren.grandle@va.gov    
Principal Investigator: J Riley McCarten, MD            
Veterans Affairs Medical Center (Brain Science Center) Recruiting
Minneapolis, Minnesota, United States, 55419
Contact: Nancy Tabaka, MS     612-467-1458        
Principal Investigator: Scott Lewis, PhD/MD            
Noran Neurology Clinic Recruiting
Plymouth, Minnesota, United States, 55441
Contact: Ann Rechtzigel, MS     612-518-9410     arechtzigel@noranclinic.com    
Principal Investigator: Richard Golden, MD            
Sponsors and Collaborators
Orasi Medical, Inc.
University of Colorado at Denver and Health Sciences Center
Radiant Research
Noran Neurology Clinic
Minneapolis Veterans Affairs Medical Center
Investigators
Principal Investigator: Todd A Verdoorn, Ph.D. Orasi Medical, Inc.
  More Information

Additional Information:
Publications:
Responsible Party: Orasi Medical, Inc. ( Timothy J. Kappers, MBA, RAC )
Study ID Numbers: ADG-08-01
Study First Received: April 23, 2008
Last Updated: November 18, 2008
ClinicalTrials.gov Identifier: NCT00666445     History of Changes
Health Authority: United States: Institutional Review Board

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

Study placed in the following topic categories:
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

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

ClinicalTrials.gov processed this record on May 07, 2009