Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test
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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 |
- 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 |
Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.
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:
- 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:
- 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.
- Have dementia due to multiple etiologies (e.g. mixed dementia)
- Show the presence of prominent disturbances in gait thought to be associated with Parkinsonism.
- Show prominent changes in personality or social conduct prior to the onset of prominent cognitive dysfunction
- Have a Modified Hachinski Ischemia Scale score of greater than 4
- Have a history of primary psychotic disorder (e.g schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder
- Have a lifetime or current history of alcohol or substance abuse/dependence
- Have had an MRI two weeks prior to completing the MEG scan
- Have metal braces or pacemaker that may interfere with the MEG scan
- 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| 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
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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013