Status:
COMPLETED
Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG)
Lead Sponsor:
Orasi Medical, Inc.
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-90 years
Brief Summary
The current study is intended to enrich and extend the database of Alzheimer's Disease (AD) and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzh...
Detailed Description
This study is intended to extend the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under development by the sponsor, Orasi Medical, Inc. Magnetoencephalography (MEG) is an F...
Eligibility Criteria
Inclusion
- Subject has been diagnosed with dementia of Alzheimer's type (DSM-IV-TR) or is serving as a healthy control subject with normal neurological function based on medical history and following neurological exam.
- AD Subject has a screen MMSE raw score \> 16 or HC subject has a screen MMSE raw score \> 26.
- Subject is between 50 and 90 years of age at the time of screening.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is a non-smoker.
- Subject is judged to be in good health other than AD, based on medical history and brief physical examination.
- AD subject has a care-giver or spouse who is willing and able to assure subject compliance with study procedures or subject is participating as a healthy control subject.
Exclusion
- Subject has a history or diagnosis of a significant neurological condition other than Alzheimer's disease including Parkinson's disease, vascular dementia, Lewy body dementia, frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, seizures, epilepsy, stroke, ADHD, dyslexia, or severe traumatic brain injury.
- Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.
- Subject has a Modified Hachinski Ischemia Scale (HIS) score greater than 4.
- The subject has a recent history (within 2 years) of alcohol or substance abuse/dependence.
- Subject had an MRI within two weeks prior to Study Day 1.
- Subject has metal dental braces, pacemaker or other common medical devices that may interfere with the MEG scan.
- Subject is unable to complete the MEG scan procedure.
- Investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT00973518
Start Date
September 1 2009
End Date
June 1 2010
Last Update
August 13 2010
Active Locations (2)
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1
Rush Alzheimer's Disease Center
Chicago, Illinois, United States, 60612
2
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, United States, 60007