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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 |
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Information provided by: | Orasi Medical, Inc. |
ClinicalTrials.gov Identifier: | NCT00666445 |
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 |
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Alzheimer's Disease |
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 |
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 |
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1
Patients diagnosed with Alzheimer's Disease
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Aged-matched normal controls
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Ages Eligible for Study: | 18 Years to 90 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.
Inclusion Criteria:
Have one of the following clinical diagnoses or conditions:
Exclusion Criteria:
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 |
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 |
Principal Investigator: | Todd A Verdoorn, Ph.D. | Orasi Medical, Inc. |
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 |
Alzheimer's Disease Diagnosis Neuronal function Cognitive Impairment Magnetoencephalography |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases Neurodegenerative Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |