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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
History of Changes
  Purpose

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.


Condition
Alzheimer's Disease

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: A Follow-up Study

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Orasi Medical, Inc.:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 120
Study Start Date: March 2011
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Ages Eligible for Study:   20 Years to 92 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01322373

Locations
United States, Minnesota
Noran Neurological Clinic
Minneapolis, Minnesota, United States, 55407
Noran Neurology Clinic
Plymouth, Minnesota, United States, 55441
Sponsors and Collaborators
Orasi Medical, Inc.
Investigators
Principal Investigator: Richard Golden, MD Noran Neurological Clinic
  More Information

No publications provided

Responsible Party: Todd Verdoorn, PhD, Chief Scientific Officer, Orasi Medical, Inc.
ClinicalTrials.gov Identifier: NCT01322373     History of Changes
Other Study ID Numbers: ADG 11-01
Study First Received: March 22, 2011
Last Updated: March 23, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Orasi Medical, Inc.:
Alzheimer's disease
magnetoencephalography
MEG
SNI

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013