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

NCT00666445 | Completed

• 1 other identifier: ADG-08-01
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease; Diagnosis; Neuronal function; Cognitive Impairment; Magnetoencephalography

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.

  Immediately

Study Arms (2)

1

Patients diagnosed with Alzheimer's Disease

2

Aged-matched normal controls

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.

You may qualify if:

• Subject is between 18 and 90 years of age
• 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
• Subjects who completed Protocol ADG 08-01 will be contacted and invited to participate in the follow-up assessment.

Sponsors & Collaborators

• Orasi Medical, Inc.: lead
• Noran Neurological Clinic: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (3)

Veterans Affairs Medical Center (Brain Science Center)

Minneapolis, Minnesota, 55419, United States

Location

Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center)

Minneapolis, Minnesota, 55419, United States

Location

Noran Neurology Clinic

Plymouth, Minnesota, 55441, United States

Location

Related 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. doi: 10.1088/1741-2560/4/4/001. Epub 2007 Aug 27.

  PMID: 18057502 BACKGROUND

Related Links

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

MeSH Terms

Conditions

Alzheimer Disease; Disease; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognition Disorders

Study Officials

• Todd A Verdoorn, Ph.D.

  Orasi Medical, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: April 23, 2008
• First Posted: April 25, 2008
• Study Start: April 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: August 13, 2010

Record last verified: 2010-08

Locations

US (3)