Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: AD Template Development Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Orasi Medical, Inc.
- Enrollment
- 150
- Locations
- 3
- Primary Endpoint
- Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Cross Sectional
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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.
Outcomes
Primary Outcomes
Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.
Time Frame: Immediately
Secondary Outcomes
No secondary outcomes reported