Clinical trial NCT01322373: A Study of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test
Official title: Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: A Follow-up Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
magnetoencephalography
MEG
SNI
Lead sponsor: Orasi Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2011-03-24
Enrollment: 120
Sex: ALL
Minimum age (years): 20
Maximum age (years): 92
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who enrolled and completed Orasi Protocol ADG 08-01 will be contacted and invited to participate in this follow-up study.

Brief summary: This follow-up study is designed to obtain longitudinal clinical and MEG scan data to gain information on Alzheimer's disease (AD) progression, the stability of healthy control (HC) MEG scan data, to enrich the Orasi database of AD and HC subjects, and is intended to extend the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under development by the sponsor, Orasi Medical. The current study is intended to extend the database of AD and HC MEG scans and will include patients who previously enrolled and completed Orasi Protocol ADG 08-01. This study will include MEG scans on up to approximately 50 AD subjects and 70 HC subjects. Additionally, AD subjects will complete 3 standard functional tests while HC subjects will complete 2 standard functional tests. ApoE genotyping also will be determined for all subjects. The results generated in this study will be used to improve the accuracy of the SNI test for diagnosing and tracking the progression of AD.


Eligibility criteria: Inclusion Criteria:

* Subject enrolled and completed Orasi Protocol ADG 08-01
* Subject understands the study procedures and agrees to participate in the study by giving written informed consent. In the event the subject lacks the capacity to sign the consent form then the subject's Legally Authorized Representative (LAR) may sign on the subject's behalf. See Section 5. Informed Consent for details.
* Subject is a non-smoker.
* Subject is judged to be in good health other than AD, if applicable

Exclusion Criteria:

* Subject has a history or diagnosis of a significant neurological condition other than Alzheimer's disease including Parkinson's disease, vascular dementia, Lewy body dementia, frontal temporal dementia, human immunodeficiency virus, multiple sclerosis, seizures, epilepsy, stroke, ADHD, dyslexia, or severe traumatic brain injury.
* Subject has a history of primary psychotic disorder (e.g. schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder.
* Subject has a Modified Hachinski Ischemia Scale (HIS) score greater than 4.
* The subject has a recent history (within 2 years) of alcohol or substance abuse/dependence.
* Subject had an MRI within two weeks prior to Study Visit 2.
* Subject has metal dental braces, pacemaker or other common medical devices that may interfere with the MEG scan.
* Subject is unable to complete the MEG scan procedure.
* Investigator has any concern regarding the safe participation of a subject in the study, or if for any other reason the investigator considers the subject inappropriate for study participation

Primary outcomes:
measure: Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ consistently between HC and AD subjects.
timeFrame: Up to 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Noran Neurological Clinic
state: Minnesota
city: Plymouth
country: United States
facility: Noran Neurology Clinic
state: Minnesota
Study officials:
affiliation: Noran Neurological Clinic
name: Richard Golden, MD
role: PRINCIPAL_INVESTIGATOR
References: