- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00973518
Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG)
Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction Test: A One-month Study
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.
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
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Illinois
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Chicago, Illinois, United States, 60612
- Rush Alzheimer's Disease Center
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Elk Grove Village, Illinois, United States, 60007
- Alexian Brothers Neuroscience Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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 Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Alzheimer's Disease subjects
Subjects diagnosed with dementia of Alzheimer's type (DSM-IV-TR).
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Healthy Control subjects
Age & gender-matched subjects determined to be healthy.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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approximately 30 days
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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
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Approximately 30 days
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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Approximately 30 days
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Identification and characterization of Orasi SNI test features that correlate with AD medications being taken by AD subjects
Time Frame: Approximately one month
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Approximately one month
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Identification, characterization and comparison of scan results generated by MEG and EEG
Time Frame: Approximately one month
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Approximately one month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Concetta Forchetti, MD, PhD, Alexian Brothers Neuroscience Institute
- Principal Investigator: Raj C Shah, MD, Rush Alzheimer's Disease Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- ADD 09-02
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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