Alzheimer's DiseaseNCT00666445
Improved Diagnosis of Alzheimer's Disease Using the Synchronous Neural Interaction™ Test
An observational study of Alzheimer's Disease, run by Orasi Medical, Inc. at 3 sites in United States.
Trial summary
This study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test is useful for diagnosing Probable Alzheimer's Disease according to standard criteria. Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects will be evaluated for symptoms of Alzheimer's… Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Apr 2008to Dec 2009
- 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 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.
Who may be able to join
- Subject is between 18 and 90 years of age
- i. Provide written informed consent for study participation, OR ii. Provide written assent to study participant accompanied by the provision of written informed by the subject's legally authorized representative (LAR); see Section 8. Informed Consent for details of the procedures use to meet these study inclusion criteria
- Have one of the following clinical diagnoses or conditions:
- Probable AD according to the NINCDS-ADRDA criteria
- Possible AD according to the NINCDS-ADRDA criteria
- Prodromal AD according to criteria described by Dubois \& Albert (2004)
- Normal control subject
Who cannot join
- Have a significant non-AD neurological condition including Parkinson's Disease, Vascular Dementia, Lewy Body Dementia or Frontal Temporal Dementia, human immunodeficiency virus, multiple sclerosis, epilepsy, or severe traumatic brain injury.
- Have dementia due to multiple etiologies (e.g. mixed dementia)
- Show the presence of prominent disturbances in gait thought to be associated with Parkinsonism.
- Show prominent changes in personality or social conduct prior to the onset of prominent cognitive dysfunction
- Have a Modified Hachinski Ischemia Scale score of greater than 4
- Have a history of primary psychotic disorder (e.g schizophrenia, schizoaffective disorder, delusional disorder) or bipolar disorder
Show all 12Show fewer
- Have a lifetime or current history of alcohol or substance abuse/dependence
- Have had an MRI two weeks prior to completing the MEG scan
- Have metal braces or pacemaker that may interfere with the MEG scan
- Are unable to complete the MEG scan procedure
- Follow-up Assessment Inclusion Criteria:
- Subjects who completed Protocol ADG 08-01 will be contacted and invited to participate in the follow-up assessment.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Veterans Affairs Medical Center (Brain Science Center)
Minneapolis, Minnesota, 55419
Veterans Affairs Medical Center (Geriatric Research, Education and Clinical Center)
Minneapolis, Minnesota, 55419
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: AD Template Development Study
This study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test is useful for diagnosing Probable Alzheimer's Disease according to standard criteria. Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects will be evaluated for symptoms of Alzheimer's Disease and those meeting inclusion criteria will undergo a brief, non-invasive scan of brain function using a magnetoencephalography (MEG). The scan itself lasts 1 minute while the subject is asked to stare at a dot projected in front of them on a video screen. Orasi Medical believes that patterns of brain activity measured at rest are indicative of Alzheimer's Disease pathology.
The protocol is amended to add a follow-up assessment for previously enrolled and completed subjects who agree to participate in the follow-up assessment approximately 9 - 15 months after initial study enrollment. Subjects who agree to participate in the follow-up assessment will undergo the same standardized tests and MEG scan procedure as completed in the initial study.
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Diagnosis, Neuronal function, Cognitive Impairment, Magnetoencephalography
- Medical subject headings
- Alzheimer Disease, Disease, Cognitive Dysfunction
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 |
|---|---|---|
| 1 | Patients diagnosed with Alzheimer's Disease | |
| 2 | Aged-matched normal controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.
Measured: Immediately
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2008 (estimated)
- Study startApr 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Orasi Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Noran Neurological Clinic, Minneapolis Veterans Affairs Medical Center
- Investigators
- Todd A Verdoorn, Ph.D., Principal investigator, Orasi Medical, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00666445
- Sponsor's protocol ID
- ADG-08-01
- Status last verified
- Aug 2010
- First submitted
- 23 Apr 2008
- Last updated
- 13 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Georgopoulos AP, Karageorgiou E, Leuthold AC, Lewis SM, Lynch JK, Alonso AA, Aslam Z, Carpenter AF, Georgopoulos A, Hemmy LS, Koutlas IG, Langheim FJ, McCarten JR, McPherson SE, Pardo JV, Pardo PJ, Parry GJ, Rottunda SJ, Segal BM, Sponheim SR, Stanwyck JJ, Stephane M, Westermeyer JJ. Synchronous neural interactions assessed by magnetoencephalography: a functional biomarker for brain disorders. J Neural Eng. 2007 Dec;4(4):349-55. doi: 10.1088/1741-2560/4/4/001. Epub 2007 Aug 27.
PubMed 18057502
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: AD Template Development Study
- ClinicalTrials.gov ID
- NCT00666445
- Acronym / sponsor ID
- ADG-08-01
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's Disease, Diagnosis, Neuronal function, Cognitive Impairment, Magnetoencephalography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Orasi Medical, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Noran Neurological Clinic, Minneapolis Veterans Affairs Medical Center
- Study start
- Apr 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 25 Apr 2008 (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 study is designed to test the hypothesis that the Synchronous Neural Interaction™ Test is useful for diagnosing Probable Alzheimer's Disease according to standard criteria. Subjects diagnosed with Alzheimer's Disease as well as age-matched normal control subjects will be evaluated for symptoms of Alzheimer's Disease and those meeting inclusion criteria will undergo a brief, non-invasive scan of brain function using a magnetoencephalography (MEG). The scan itself lasts 1 minute while the subject is asked to stare at a dot projected in front of them on a video screen. Orasi Medical believes that patterns of brain activity measured at rest are indicative of Alzheimer's Disease pathology.
The protocol is amended to add a follow-up assessment for previously enrolled and completed subjects who agree to participate in the follow-up assessment approximately 9 - 15 months after initial study enrollment. Subjects who agree to participate in the follow-up assessment will undergo the same standardized tests and MEG scan procedure as completed in the initial study.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients diagnosed with Alzheimer's Disease |
| 2 | – | –Aged-matched normal controls |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects will be referred from dementia/Alzheimer's Disease clinical patients at study sites.
Key inclusion criteria (7 listed)
- Subject is between 18 and 90 years of age
- i. Provide written informed consent for study participation, OR ii. Provide written assent to study participant accompanied by the provision of written informed by the subject's legally authorized representative (LAR); see Section 8. Informed Consent for details of the procedures use to meet these study inclusion criteria
- Have one of the following clinical diagnoses or conditions:
Key exclusion criteria (12 listed)
- Have a significant non-AD neurological condition including Parkinson's Disease, Vascular Dementia, Lewy Body Dementia or Frontal Temporal Dementia, human immunodeficiency virus, multiple sclerosis, epilepsy, or severe traumatic brain injury.
- Have dementia due to multiple etiologies (e.g. mixed dementia)
- Show the presence of prominent disturbances in gait thought to be associated with Parkinsonism.
- Show prominent changes in personality or social conduct prior to the onset of prominent cognitive dysfunction
- Have a Modified Hachinski Ischemia Scale score of greater than 4
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
Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease.
Time frame: Immediately
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.
- Background: PubMed 18057502Georgopoulos AP, Karageorgiou E, Leuthold AC, Lewis SM, Lynch JK, Alonso AA, Aslam Z, Carpenter AF, Georgopoulos A, Hemmy LS, Koutlas IG, Langheim FJ, McCarten JR, McPherson SE, Pardo JV, Pardo PJ, Parry GJ, Rottunda SJ, Segal BM, Sponheim SR, Stanwyck JJ, Stephane M, Westermeyer JJ. Synchronous neural interactions assessed by magnetoencephalography: a functional biomarker for brain disorders. J Neural Eng. 2007 Dec;4(4):349-55. doi: 10.1088/1741-2560/4/4/001. Epub 2007 Aug 27.
- Minnesota Alzheimers AssociationLink provided by the sponsor.
- Colorado Alzheimers AssociationLink provided by the sponsor.
- Texas Alzheimers AssociationLink provided by the sponsor.
Related trials for Alzheimer's Disease
RecruitingPhase 2
Neuroplasticity Enhancement From Cognitive Training Reinforced by Psilocybin
Alzheimer's Disease
Not yet recruiting
Acupressure as Long-term Intervention to Slow the Progression of Early/Mild Alzheimer's Disease
Alzheimer's Disease
RecruitingObservational study
Effectiveness and Safety of Disease-Modifying Therapy for Alzheimer's Disease: A Multicenter Retrospective Study
Alzheimer's Disease (AD)
RecruitingPhase 3
A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
Alzheimer Disease
RecruitingPhase 3
A Study of Trontinemab in Cognitively Unimpaired Individuals at Risk for Progression to Symptomatic Alzheimer's Disease
Alzheimer's Disease
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.
Todd A Verdoorn, Ph.D. principal investigator
Orasi Medical, Inc.
3 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 3 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 12 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 3 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?
Sensitivity and specificity for test under investigation to diagnose probable Alzheimer's Disease. (time frame: Immediately). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00666445, which also lists 1 linked publication.
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.