A Study of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test
This follow-up study is designed to obtain longitudinal clinical and MEG scan data to gain information on Alzheimer's disease (AD) progression, the stability of healthy control (HC) MEG scan data, to enrich the Orasi database of AD and HC subjects, and is intended to extend the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under development by the sponsor, Orasi Medical. The current study is intended to extend the database of AD and HC MEG scans and will include patients who previously enrolled and completed Orasi Protocol ADG 08-01. This study will include MEG scans on up to approximately 50 AD subjects and 70 HC subjects. Additionally, AD subjects will complete 3 standard functional tests while HC subjects will complete 2 standard functional tests. ApoE genotyping also will be determined for all subjects. The results generated in this study will be used to improve the accuracy of the SNI test for diagnosing and tracking the progression of AD.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: A Follow-up Study|
- Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ consistently between HC and AD subjects. [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||March 2011|
|Estimated Study Completion Date:||August 2011|
|Estimated Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
Healthy control subjects (HC)
Subjects who met criteria as healthy control subjects and completed Orasi Protocol ADG-08-01.
Alzheimer's disease subjects (AD)
Subjects with a diagnosis of DAT according to DSM-IV-TR criteria who completed Orasi Protocol ADG-08-01.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322373
|United States, Minnesota|
|Noran Neurological Clinic|
|Minneapolis, Minnesota, United States, 55407|
|Noran Neurology Clinic|
|Plymouth, Minnesota, United States, 55441|
|Principal Investigator:||Richard Golden, MD||Noran Neurological Clinic|