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| Sponsor: | Orasi Medical, Inc. |
|---|---|
| Collaborators: |
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.
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: | 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: | February 2010 |
| Estimated Primary Completion Date: | February 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
1
Patients diagnosed with Alzheimer's Disease
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|
2
Aged-matched normal controls
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Eligibility| 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:
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| United States, Minnesota | |
| Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center) | |
| Minneapolis, Minnesota, United States, 55419 | |
| Veterans Affairs Medical Center (Brain Science Center) | |
| Minneapolis, Minnesota, United States, 55419 | |
| Noran Neurology Clinic | |
| Plymouth, Minnesota, United States, 55441 | |
| Principal Investigator: | Todd A Verdoorn, Ph.D. | Orasi Medical, Inc. |
More Information
| Responsible Party: | Orasi Medical, Inc. ( Todd Verdoorn, Ph.D., Chief Scientific Officer ) |
| Study ID Numbers: | ADG-08-01 |
| Study First Received: | April 23, 2008 |
| Last Updated: | July 28, 2009 |
| ClinicalTrials.gov Identifier: | NCT00666445 History of Changes |
| Health Authority: | United States: Institutional Review Board |
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Alzheimer's Disease Diagnosis Neuronal function Cognitive Impairment Magnetoencephalography |
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Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Nervous System Diseases Alzheimer Disease Central Nervous System Diseases |
Neurodegenerative Diseases Tauopathies Brain Diseases Dementia |