Alzheimer's DiseaseNCT01322373
A Study of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test
An observational study of Alzheimer's Disease, run by Orasi Medical, Inc. at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 to 92 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- Type of treatment
- Injection or infusion
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2011to Aug 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 92 years
- All sexes
- Healthy volunteers accepted
- Adult, Older 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Noran Neurological Clinic
Minneapolis, Minnesota, 55407
Noran Neurology Clinic
Plymouth, Minnesota, 55441
About this study
Official title: 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.
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, magnetoencephalography, MEG, SNI
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionAug 2011 (estimated)
- Study completionAug 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orasi Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Golden, MD, Principal investigator, Noran Neurological Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01322373
- Sponsor's protocol ID
- ADG 11-01
- Status last verified
- Mar 2011
- First submitted
- 22 Mar 2011
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction™ Test: A Follow-up Study
- ClinicalTrials.gov ID
- NCT01322373
- Acronym / sponsor ID
- ADG 11-01
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's disease, magnetoencephalography, MEG, SNI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Orasi Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2011
- Primary completion
- Aug 2011 (estimated)
- Study completion
- Aug 2011 (estimated)
- First posted
- 24 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 20 to 92 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Golden, MD principal investigator
Noran Neurological Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alzheimer's Disease, run by Orasi Medical, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2011.