Alzheimer's DiseaseNCT00582127
Evaluation of the COGNISION(TM) System as an Event-related Potential (ERP) Collection System.
An observational study of Alzheimer's Disease, run by Neuronetrix, Inc. at 1 site in United States.
Trial summary
This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting. An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2008to Nov 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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients and family from the University of Kentucky Sanders Brown Center for Aging
Who may be able to join
- Age 60 to 85
- Mild to moderate diagnosis of Alzhiemer's disease
- Age 60 to 85
- Cognitively healthy with no complaints
Who cannot join
- Subjects with advanced AD and severe impairment (CDR > 2, MMSE less than 15)
- Neurological disorders such as stroke, Parkinson's disease, Huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia)
- Subjects with life threatening illnesses and subjects with significant hearing or visual impairments
- Subjects with a current prescription for psychoactive pharmaceuticals
Trial locations and contacts
1 site in 1 country.
United States1 site
Sanders Brown Center for Aging, Neurology Dept.
Lexington, Kentucky, 40506
About this study
Official title: Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease
This study will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.
An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. By doing this study, we hope to evaluate various performance parameters of the COGNISION(TM) system.
Read the detailed description
Patients who have a current diagnosis of mild-moderate dementia and suspected of having Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited for this study. The Alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study.
Both groups, AD and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each subject's head will then record the electrical signals during this task.
Four important features of the COGNISION(TM) will be investigated:
- Patient tolerance
- Ease of use
- Data quality
- Network architecture
- Conditions
- Alzheimer's Disease
- Keywords
- senile, dementia
- Medical subject headings
- Alzheimer Disease, Dementia
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 | Mild-moderate Alzheimer's Disease | |
| 2 | Age-matched Controls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Signal to noise ratio (SNR) of ERPs
Measured: 9 months
Secondary outcomes (1)
Patient tolerance of the COGNISION(TM) system.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startJan 2008
- Primary completionNov 2010
- Study completionNov 2010
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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neuronetrix, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Kentucky
- Investigators
- Charles D Smith, M.D., Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00582127
- Sponsor's protocol ID
- VAL-UK-01
- Status last verified
- Dec 2010
- First submitted
- 19 Dec 2007
- Last updated
- 24 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Polikar R, Topalis A, Green D, Kounios J, Clark CM. Comparative multiresolution wavelet analysis of ERP spectral bands using an ensemble of classifiers approach for early diagnosis of Alzheimer's disease. Comput Biol Med. 2007 Apr;37(4):542-58. doi: 10.1016/j.compbiomed.2006.08.012. Epub 2006 Sep 20.
PubMed 16989799
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Handheld Evoked Response Potentials (ERP) System as an Effective Method to Diagnose Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00582127
- Acronym / sponsor ID
- VAL-UK-01
- Conditions
- Alzheimer's Disease
- Keywords
- senile, dementia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Neuronetrix, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Kentucky
- Study start
- Jan 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 28 Dec 2007 (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 will evaluate a handheld event-related potential (ERP) testing device from Neuronetrix, Inc. as a method to collect ERP data in an outpatient setting.
An ERP system records electrical signals at the scalp that are produced by the brain when performing cognitive tasks. By doing this study, we hope to evaluate various performance parameters of the COGNISION(TM) system.
Detailed description
Patients who have a current diagnosis of mild-moderate dementia and suspected of having Alzheimer's disease (AD) along with cognitively normal age-matched controls will be recruited for this study. The Alzheimer's subjects either will have had a complete clinical and neuropsychiatric workup or will have those tests performed during the study.
Both groups, AD and controls will be asked to listen to a series of sounds and press a button on a handheld control box when a target sound is heard. The COGNISION(TM) headset on each subject's head will then record the electrical signals during this task.
Four important features of the COGNISION(TM) will be investigated:
- Patient tolerance
- Ease of use
- Data quality
- Network architecture
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Mild-moderate Alzheimer's Disease |
| 2 | – | –Age-matched Controls |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients and family from the University of Kentucky Sanders Brown Center for Aging
Key inclusion criteria (4 listed)
- Age 60 to 85
- Mild to moderate diagnosis of Alzhiemer's disease
- Age 60 to 85
- Cognitively healthy with no complaints
Key exclusion criteria (4 listed)
- Subjects with advanced AD and severe impairment (CDR > 2, MMSE less than 15)
- Neurological disorders such as stroke, Parkinson's disease, Huntington's disease, multiple sclerosis, brain tumor, delirium, or psychiatric disorder other than depression (e.g. schizophrenia)
- Subjects with life threatening illnesses and subjects with significant hearing or visual impairments
- Subjects with a current prescription for psychoactive pharmaceuticals
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
Signal to noise ratio (SNR) of ERPs
Time frame: 9 months
1 secondary outcome
Patient tolerance of the COGNISION(TM) system.
Time frame: 9 months
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 24 Dec 2010.
- Background: PubMed 16989799Polikar R, Topalis A, Green D, Kounios J, Clark CM. Comparative multiresolution wavelet analysis of ERP spectral bands using an ensemble of classifiers approach for early diagnosis of Alzheimer's disease. Comput Biol Med. 2007 Apr;37(4):542-58. doi: 10.1016/j.compbiomed.2006.08.012. Epub 2006 Sep 20.
- Website for manufacturer of COGNISION(tm) System being testedLink 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.
Charles D Smith, M.D. principal investigator
University of Kentucky
1 site 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 Neuronetrix, Inc. at 1 site 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 4 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 24 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Signal to noise ratio (SNR) of ERPs (time frame: 9 months). 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 NCT00582127, 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 24 Dec 2010.