Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG)

Completed

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT00973518

Run by

Orasi Medical, Inc.

People needed

160

Starts

2009-09-01

Expected to finish

2010-06-01

Last updated by the study team

2010-08-13

Who can join

Age: 50 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Rush Alzheimer's Disease Center — Chicago, Illinois, United States
• Alexian Brothers Neuroscience Institute — Elk Grove Village, Illinois, United States

Full record on ClinicalTrials.gov

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