Official Title: “Improved Diagnosis of Alzheimer’s Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: AD Template Development Study”
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.
- Study Type: Observational
- Study Design: Observational Model: Case Control, Time Perspective: Cross-Sectional
- Study Primary Completion Date: December 2009
Arms, Groups and Cohorts in this Clinical Trial
- Patients diagnosed with Alzheimer’s Disease
- Aged-matched normal controls
Outcome Measures for this Clinical Trial
- Sensitivity and specificity for test under investigation to diagnose probable Alzheimer’s Disease.
- Time Frame: Immediately
Safety Issue?: No
- Time Frame: Immediately
Criteria for Participation in this Clinical Trial
1. Subject is between 18 and 90 years of age
2. 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
3. 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
1. 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.
2. Have dementia due to multiple etiologies (e.g. mixed dementia)
3. Show the presence of prominent disturbances in gait thought to be associated with Parkinsonism.
4. Show prominent changes in personality or social conduct prior to the onset of prominent cognitive dysfunction
5. Have a Modified Hachinski Ischemia Scale score of greater than 4
6. Have a history of primary psychotic disorder (e.g schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder
7. Have a lifetime or current history of alcohol or substance abuse/dependence
8. Have had an MRI two weeks prior to completing the MEG scan
9. Have metal braces or pacemaker that may interfere with the MEG scan
10. 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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 18 Years
Maximum Age for this Clinical Trial: 90 Years
Are Healthy Volunteers Accepted for this Clinical Trial: Accepts Healthy Volunteers
Clinical Trial Investigator Information
- Lead Sponsor
- Orasi Medical, Inc.
- Noran Neurological Clinic
- Provider of Information About this Clinical Study
- Todd Verdoorn, Ph.D., Chief Scientific Officer, Orasi Medical, Inc.
- Overall Official(s)
- Todd A Verdoorn, Ph.D., Principal Investigator, Orasi Medical, Inc.
Georgopoulos AP, Karageorgiou E, Leuthold AC, Lewis SM, Lynch JK, Alonso AA, Aslam Z, Carpenter AF, Georgopoulos A, Hemmy LS, Koutlas IG, Langheim FJ, McCarten JR, McPherson SE, Pardo JV, Pardo PJ, Parry GJ, Rottunda SJ, Segal BM, Sponheim SR, Stanwyck JJ, Stephane M, Westermeyer JJ. Synchronous neural interactions assessed by magnetoencephalography: a functional biomarker for brain disorders. J Neural Eng. 2007 Dec;4(4):349-55. Epub 2007 Aug 27.