A Study of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Orasi Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01322373
First received: March 22, 2011
Last updated: March 23, 2011
Last verified: March 2011

March 22, 2011
March 23, 2011
March 2011
August 2011   (final data collection date for primary outcome 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. [ Time Frame: Up to 3 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01322373 on ClinicalTrials.gov Archive Site
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A Study of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test
Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: A Follow-up Study

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.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Subjects who enrolled and completed Orasi Protocol ADG 08-01 will be contacted and invited to participate in this follow-up study.

Alzheimer's Disease
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  • Healthy control subjects (HC)
    Subjects who met criteria as healthy control subjects and completed Orasi Protocol ADG-08-01.
  • Alzheimer's disease subjects (AD)
    Subjects with a diagnosis of DAT according to DSM-IV-TR criteria who completed Orasi Protocol ADG-08-01.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
120
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 92 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01322373
ADG 11-01
No
Todd Verdoorn, PhD, Chief Scientific Officer, Orasi Medical, Inc.
Orasi Medical, Inc.
Not Provided
Principal Investigator: Richard Golden, MD Noran Neurological Clinic
Orasi Medical, Inc.
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP