Status:
COMPLETED
Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test
Lead Sponsor:
Orasi Medical, Inc.
Collaborating Sponsors:
Noran Neurological Clinic
Minneapolis Veterans Affairs Medical Center
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
18-90 years
Brief Summary
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 wit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00666445
Start Date
April 1 2008
End Date
December 1 2009
Last Update
August 13 2010
Active Locations (3)
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1
Veterans Affairs Medical Center (Brain Science Center)
Minneapolis, Minnesota, United States, 55419
2
Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center)
Minneapolis, Minnesota, United States, 55419
3
Noran Neurology Clinic
Plymouth, Minnesota, United States, 55441