NCT01322373

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2011

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 24, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

March 24, 2011

Status Verified

March 1, 2011

Enrollment Period

5 months

First QC Date

March 22, 2011

Last Update Submit

March 23, 2011

Conditions

Alzheimer's Disease

Keywords

Alzheimer's diseasemagnetoencephalographyMEGSNI

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

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 Criteria

Age20 Years - 92 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Noran Neurological Clinic

Minneapolis, Minnesota, 55407, United States

Location

Noran Neurology Clinic

Plymouth, Minnesota, 55441, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Richard Golden, MD

    Noran Neurological Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

March 22, 2011

First Posted

March 24, 2011

Study Start

March 1, 2011

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 24, 2011

Record last verified: 2011-03

Locations

US(2)