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| Name | Class |
|---|---|
| Noran Neurological Clinic | UNKNOWN |
| Minneapolis Veterans Affairs Medical Center | FED |
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This study is designed to test the hypothesis that the Synchronous Neural Interactionâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Patients diagnosed with Alzheimer's Disease | ||
| 2 | Aged-matched normal controls |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease. | Immediately |
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Inclusion Criteria:
Subject is between 18 and 90 years of age
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
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.
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Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.
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| Name | Affiliation | Role |
|---|---|---|
| Todd A Verdoorn, Ph.D. | Orasi Medical, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veterans Affairs Medical Center (Brain Science Center) | Minneapolis | Minnesota | 55419 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18057502 | Background | Georgopoulos AP, Karageorgiou E, Leuthold AC, Lewis SM, Lynch JK, Alonso AA, Aslam Z, Carpenter AF, Georgopoulos A, Hemmy LS, Koutlas IG, Langheim FJ, McCarten JR, McPherson SE, Pardo JV, Pardo PJ, Parry GJ, Rottunda SJ, Segal BM, Sponheim SR, Stanwyck JJ, Stephane M, Westermeyer JJ. Synchronous neural interactions assessed by magnetoencephalography: a functional biomarker for brain disorders. J Neural Eng. 2007 Dec;4(4):349-55. doi: 10.1088/1741-2560/4/4/001. Epub 2007 Aug 27. |
| Label | URL |
|---|---|
| Minnesota Alzheimers Association | View source |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| D004194 | Disease |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center) |
| Minneapolis |
| Minnesota |
| 55419 |
| United States |
| Noran Neurology Clinic | Plymouth | Minnesota | 55441 | United States |
| Colorado Alzheimers Association | View source |
| Texas Alzheimers Association | View source |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |