Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG)
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|ClinicalTrials.gov Identifier: NCT00973518|
Recruitment Status : Completed
First Posted : September 9, 2009
Last Update Posted : August 13, 2010
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 Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and electroencephalography (EEG) scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests.
This study will test the following hypotheses:
- MEG scans of resting-state, eyes-open brain function reveal patterns of correlated activity that differ between HC subjects and subjects diagnosed with dementia of Alzheimer's type;
- Patterns of correlated activity measured in AD subjects correspond to other measures of disease severity such as standard functional test scores;
- MEG scan patterns for HC subjects are consistent across repeated measures taken over a 30 day period.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||160 participants|
|Official Title:||Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction Test: A One-month Study|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
Alzheimer's Disease subjects
Subjects diagnosed with dementia of Alzheimer's type (DSM-IV-TR).
Healthy Control subjects
Age & gender-matched subjects determined to be healthy.
- Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ consistently (e.g. at all evaluation time points) between HC and AD subjects [ Time Frame: approximately 30 days ]
- Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ across time points within single subjects and across groups of HC and AD subjects [ Time Frame: Approximately 30 days ]
- Identification and characterization of Orasi SNI test features that correlate with independent measures of cognitive function based on functional testing (ADAS-Cog sum of boxes, and MMSE raw score, One Card Learning Test) [ Time Frame: Approximately 30 days ]
- Identification and characterization of Orasi SNI test features that correlate with AD medications being taken by AD subjects [ Time Frame: Approximately one month ]
- Identification, characterization and comparison of scan results generated by MEG and EEG [ Time Frame: Approximately one month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00973518
|United States, Illinois|
|Rush Alzheimer's Disease Center|
|Chicago, Illinois, United States, 60612|
|Alexian Brothers Neuroscience Institute|
|Elk Grove Village, Illinois, United States, 60007|
|Principal Investigator:||Concetta Forchetti, MD, PhD||Alexian Brothers Neuroscience Institute|
|Principal Investigator:||Raj C Shah, MD||Rush Alzheimer's Disease Center|