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

Alzheimer's Disease Clinical Trial

Official title:

Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: AD Template Development Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00666445
• Other study ID #: ADG-08-01
• Status: Completed
• Phase: N/A
• First received: April 23, 2008
• Last updated: August 12, 2010
• Start date: April 2008
• Est. completion date: December 2009

Study information

• Verified date: August 2010
• Source: Orasi Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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.

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Locations

Country	Name	City	State
United States	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

Sponsors (3)

Lead Sponsor	Collaborator
Orasi Medical, Inc.	Minneapolis Veterans Affairs Medical Center, Noran Neurological Clinic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.		Immediately	No

External Links

•   Colorado Alzheimers Association
•   Minnesota Alzheimers Association
•   Texas Alzheimers Association