Clinical trial NCT00666445: Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test
Official title: Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: AD Template Development Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease
Diagnosis
Neuronal function
Cognitive Impairment
Magnetoencephalography
Lead sponsor: Orasi Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Noran Neurological Clinic
name: Minneapolis Veterans Affairs Medical Center
First posted: 2008-04-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.
timeFrame: Immediately
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Veterans Affairs Medical Center (Brain Science Center)
state: Minnesota
city: Minneapolis
country: United States
facility: Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center)
state: Minnesota
city: Plymouth
country: United States
facility: Noran Neurology Clinic
state: Minnesota
Study officials:
affiliation: Orasi Medical, Inc.
name: Todd A Verdoorn, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.