Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test

Completed

Conditions studied: Alzheimer's Disease

In brief

This study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test is useful for diagnosing Probable Alzheimer's Disease according to standard criteria. Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects will be evaluated for symptoms of Alzheimer's Disease and those meeting inclusion criteria will undergo a brief, non-invasive scan of brain function using a magnetoencephalography (MEG). The scan itself lasts 1 minute while the subject is asked to stare at a dot projected in front of them on a video screen. Orasi Medical believes that patterns of brain activity measured at rest are indicative of Alzheimer's Disease pathology. The protocol is amended to add a follow-up assessment for previously enrolled and completed subjects who agree to participate in the follow-up assessment approximately 9 - 15 months after initial study enrollment. Subjects who agree to participate in the follow-up assessment will undergo the same standardized tests and MEG scan procedure as completed in the initial study.

Key facts

Study ID: NCT00666445
Run by: Orasi Medical, Inc.
People needed: 150
Starts: 2008-04-01
Expected to finish: 2009-12-01
Last updated by the study team: 2010-08-13

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: accepted.

You may qualify if…

Subject is between 18 and 90 years of age
i. Provide written informed consent for study participation, OR ii. Provide written assent to study participant accompanied by the provision of written informed by the subject's legally authorized representative (LAR); see Section 8. Informed Consent for details of the procedures use to meet these study inclusion criteria
Have one of the following clinical diagnoses or conditions:
Probable AD according to the NINCDS-ADRDA criteria
Possible AD according to the NINCDS-ADRDA criteria
Prodromal AD according to criteria described by Dubois \& Albert (2004)
Normal control subject

You may not qualify if…

Have a significant non-AD neurological condition including Parkinson's Disease, Vascular Dementia, Lewy Body Dementia or Frontal Temporal Dementia, human immunodeficiency virus, multiple sclerosis, epilepsy, or severe traumatic brain injury.
Have dementia due to multiple etiologies (e.g. mixed dementia)
Show the presence of prominent disturbances in gait thought to be associated with Parkinsonism.
Show prominent changes in personality or social conduct prior to the onset of prominent cognitive dysfunction
Have a Modified Hachinski Ischemia Scale score of greater than 4
Have a history of primary psychotic disorder (e.g schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder
Have a lifetime or current history of alcohol or substance abuse/dependence
Have had an MRI two weeks prior to completing the MEG scan
Have metal braces or pacemaker that may interfere with the MEG scan
Are unable to complete the MEG scan procedure
Follow-up Assessment Inclusion Criteria:
Subjects who completed Protocol ADG 08-01 will be contacted and invited to participate in the follow-up assessment.

Where it is running

Veterans Affairs Medical Center (Brain Science Center) — Minneapolis, Minnesota, United States
Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center) — Minneapolis, Minnesota, United States
Noran Neurology Clinic — Plymouth, Minnesota, United States

Full record on ClinicalTrials.gov

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