A Study of Alzheimer's Disease Using Magnetoencephalograp... | NCT01322373

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

NCT01322373

Sponsor

Orasi Medical, Inc.

Status

Unknown status

Last Update Posted

Mar 24, 2011Estimated

Enrollment

120Estimated

Phase

Not provided

Conditions

Alzheimer's Disease

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Enrolling by invitation

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Aug 2011Estimated

Completion Date

Aug 2011Estimated

First Submitted Date

Mar 22, 2011

First Submission Date that Met QC Criteria

Mar 23, 2011

First Posted Date

Mar 24, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 23, 2011

Last Update Posted Date

Mar 24, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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.

Interventions

Not provided

Measure	Description	Time Frame
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.		Up to 3 weeks

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

92 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Noran Neurological Clinic		Minneapolis	Minnesota	55407	United States
Noran Neurology Clinic

ID	Term
D003704	Dementia
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases