Alzheimer's DiseaseNCT00973518
Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG)
An observational study of Alzheimer's Disease, run by Orasi Medical, Inc. at 2 sites in United States.
Trial summary
The current study is intended to enrich and extend the database of Alzheimer's Disease (AD) and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. Read more about this study
- Who is it for?
- Ages 50 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- Type of treatment
- Injection or infusion
- How many people
- 160 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Jun 2010
- 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 50 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The current study will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched healthy control subjects meeting criteria of normal neurological function.
Who may be able to join
- Subject has been diagnosed with dementia of Alzheimer's type (DSM-IV-TR) or is serving as a healthy control subject with normal neurological function based on medical history and following neurological exam.
- AD Subject has a screen MMSE raw score > 16 or HC subject has a screen MMSE raw score > 26.
- Subject is between 50 and 90 years of age at the time of screening.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is a non-smoker.
- Subject is judged to be in good health other than AD, based on medical history and brief physical examination.
- AD subject has a care-giver or spouse who is willing and able to assure subject compliance with study procedures or subject is participating as a healthy control subject.
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 Day 1.
- 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
Rush Alzheimer's Disease Center
Chicago, Illinois, 60612
Alexian Brothers Neuroscience Institute
Elk Grove Village, Illinois, 60007
About this study
Official title: Improved Diagnosis of Alzheimer's Disease Using Magnetoencephalography (MEG) and the Synchronous Neural Interaction Test: A One-month Study
The current study is intended to enrich and extend the database of Alzheimer's Disease (AD) and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and electroencephalography (EEG) scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests.
This study will test the following hypotheses:
- MEG scans of resting-state, eyes-open brain function reveal patterns of correlated activity that differ between HC subjects and subjects diagnosed with dementia of Alzheimer's type;
- Patterns of correlated activity measured in AD subjects correspond to other measures of disease severity such as standard functional test scores;
- MEG scan patterns for HC subjects are consistent across repeated measures taken over a 30 day period.
Read the detailed description
This study is intended to extend the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under development by the sponsor, Orasi Medical, Inc. Magnetoencephalography (MEG) is an FDA-approved, non-invasive technique used to measure magnetic fields generated by small intracellular electrical currents in neurons. The SNI test evaluates brain function and dysfunction by analyzing brief (1 minute) MEG scans and comparing individual scan results to a database of MEG scans and clinical information. Proprietary software algorithms process the data generated by MEG instruments allowing Orasi to use the SNI test for accurate tracking and diagnosis of neurological disorders such as Alzheimer's disease (AD) and Multiple Sclerosis (MS). The current study is intended to enrich and extend the database of AD and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and EEG scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests. 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. Once a robust training set or template is described, Orasi Medical will conduct additional clinical studies to formally test the diagnostic accuracy of the technology and support applications for regulatory approval to market the SNI test for AD. The objective of this work is to produce and validate a novel tracking and diagnostic technology for AD that is more selective and sensitive than currently available diagnostic tools.
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, AD, Healthy Control
- 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 |
|---|---|---|
| Alzheimer's Disease subjects | Subjects diagnosed with dementia of Alzheimer's type (DSM-IV-TR). | |
| Healthy Control subjects | Age \& gender-matched subjects determined to be healthy. |
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 (e.g. at all evaluation time points) between HC and AD subjects
Measured: approximately 30 days
Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ across time points within single subjects and across groups of HC and AD subjects
Measured: Approximately 30 days
Secondary outcomes (3)
Identification and characterization of Orasi SNI test features that correlate with independent measures of cognitive function based on functional testing (ADAS-Cog sum of boxes, and MMSE raw score, One Card Learning Test)
Measured: Approximately 30 days
Identification and characterization of Orasi SNI test features that correlate with AD medications being taken by AD subjects
Measured: Approximately one month
Identification, characterization and comparison of scan results generated by MEG and EEG
Measured: Approximately one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJun 2010
- Study completionJun 2010
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orasi Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Concetta Forchetti, MD, PhD, Principal investigator, Alexian Brothers Neuroscience InstituteRaj C Shah, MD, Principal investigator, Rush Alzheimer's Disease Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00973518
- Sponsor's protocol ID
- ADD 09-02
- Status last verified
- Aug 2010
- First submitted
- 4 Sep 2009
- Last updated
- 13 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2010. 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 One-month Study
- ClinicalTrials.gov ID
- NCT00973518
- Acronym / sponsor ID
- ADD 09-02
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, AD, Healthy Control
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Orasi Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 9 Sep 2009 (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.
The current study is intended to enrich and extend the database of Alzheimer's Disease (AD) and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and electroencephalography (EEG) scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests.
This study will test the following hypotheses:
- MEG scans of resting-state, eyes-open brain function reveal patterns of correlated activity that differ between HC subjects and subjects diagnosed with dementia of Alzheimer's type;
- Patterns of correlated activity measured in AD subjects correspond to other measures of disease severity such as standard functional test scores;
- MEG scan patterns for HC subjects are consistent across repeated measures taken over a 30 day period.
Detailed description
This study is intended to extend the capabilities of the Synchronous Neural Interaction® (SNI) test, which is under development by the sponsor, Orasi Medical, Inc. Magnetoencephalography (MEG) is an FDA-approved, non-invasive technique used to measure magnetic fields generated by small intracellular electrical currents in neurons. The SNI test evaluates brain function and dysfunction by analyzing brief (1 minute) MEG scans and comparing individual scan results to a database of MEG scans and clinical information. Proprietary software algorithms process the data generated by MEG instruments allowing Orasi to use the SNI test for accurate tracking and diagnosis of neurological disorders such as Alzheimer's disease (AD) and Multiple Sclerosis (MS). The current study is intended to enrich and extend the database of AD and healthy control (HC) MEG scans and will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched HC subjects meeting criteria of normal neurological function. This study will include 2 MEG and EEG scans on approximately 80 AD subjects and 80 HC subjects over approximately 30 days. All subjects will have MEG/EEG scans at baseline and 28 - 35 days after baseline. Within one day of each scan visit AD subjects will undergo 4 standard functional tests while HC subjects will undergo 2 standard functional tests. 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. Once a robust training set or template is described, Orasi Medical will conduct additional clinical studies to formally test the diagnostic accuracy of the technology and support applications for regulatory approval to market the SNI test for AD. The objective of this work is to produce and validate a novel tracking and diagnostic technology for AD that is more selective and sensitive than currently available diagnostic tools.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alzheimer's Disease subjects | – | –Subjects diagnosed with dementia of Alzheimer's type (DSM-IV-TR). |
| Healthy Control subjects | – | –Age \& gender-matched subjects determined to be healthy. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The current study will include patients meeting DSM-IV-TR criteria for dementia of Alzheimer's type, and age- and gender-matched healthy control subjects meeting criteria of normal neurological function.
Key inclusion criteria (7 listed)
- Subject has been diagnosed with dementia of Alzheimer's type (DSM-IV-TR) or is serving as a healthy control subject with normal neurological function based on medical history and following neurological exam.
- AD Subject has a screen MMSE raw score > 16 or HC subject has a screen MMSE raw score > 26.
- Subject is between 50 and 90 years of age at the time of screening.
- Subject understands the study procedures and agrees to participate in the study by giving written informed consent.
- Subject is a non-smoker.
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 Day 1.
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 (e.g. at all evaluation time points) between HC and AD subjects
Time frame: approximately 30 days
Identification and characterization of patterns of correlated brain activity measured by MEG and the Orasi SNI test that differ across time points within single subjects and across groups of HC and AD subjects
Time frame: Approximately 30 days
3 secondary outcomes
Identification and characterization of Orasi SNI test features that correlate with independent measures of cognitive function based on functional testing (ADAS-Cog sum of boxes, and MMSE raw score, One Card Learning Test)
Time frame: Approximately 30 days
Identification and characterization of Orasi SNI test features that correlate with AD medications being taken by AD subjects
Time frame: Approximately one month
Identification, characterization and comparison of scan results generated by MEG and EEG
Time frame: Approximately one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2010.
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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.
Concetta Forchetti, MD, PhD principal investigator
Alexian Brothers Neuroscience Institute
Raj C Shah, MD principal investigator
Rush Alzheimer's Disease Center
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 7 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: finished, as of the sponsor's last update on 13 Aug 2010. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (e.g. at all evaluation time points) between HC and AD subjects (time frame: approximately 30 days). The study lists 2 primary outcomes in all. 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 13 Aug 2010.