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

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.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Disease Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Tauopathies

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Veterans Affairs Medical Center (Brain Science Center), Minneapolis, Minnesota, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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.

Treatment and study plan

Primary outcomes

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

Time frame: Immediately

Sponsors and collaborators

Lead sponsor

Orasi Medical, Inc.

Industry

Collaborators

Minneapolis Veterans Affairs Medical Center
Noran Neurological Clinic

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 25, 2008
Registry last updated: Aug 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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