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| Sponsored by: |
Neuronetrix, Inc. |
|---|---|
| Information provided by: | Neuronetrix, Inc. |
| ClinicalTrials.gov Identifier: | NCT00938665 |
Purpose
The proposed study is designed to evaluate the performance of the COGNISION™ System as a tool to assist physicians in diagnosing Alzheimer's Disease (AD) in real-world clinical settings. The design of this study is guided by two overriding factors: 1) to optimize the performance of the event related potentials (ERP) classifiers, the subjects making up the training sets must be well characterized as to their clinical diagnosis, and 2) all ERP tests must be performed and reproduced in real-world clinical settings.
| Condition | Intervention |
|---|---|
|
Memory Disorders Alzheimer Disease Dementia Cognitive Impairment Frontotemporal Dementia |
Device: COGNISION™ System (Validating device only not intended for diagnosis) |
| Study Type: | Observational |
| Study Design: | Case Control, Prospective |
| Official Title: | To Determine Whether the COGNISION™ System Can Meet the Reported Performance of Trained Community Clinic Physicians in Differentiating Mild Alzheimer's Disease From Normal Aging in a Real-world Clinical Environment |
These lab tests will be performed from a standard blood draw:
| Estimated Enrollment: | 200 |
| Study Start Date: | September 2009 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Control Group
All Control Subjects must meet the following criteria:
|
Device: COGNISION™ System (Validating device only not intended for diagnosis)
30 mintue ERP test performed on well patient volunteers to validate EEG brainwaves and there correlation to behavioral and biomarkers for detailed validation.
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AD Group NO MEDS
The rest of the subjects will be AChEI-naïve. For the purpose of this study, subjects in the AD cohort matching all criteria and having Aβ1-42 > 192pg/mL (Leslie Shaw, PhD, University of Pennsylvania, personal communications) will be considered as subjects with 'Non-specific dementia'. In neural network theory, the data used to form the training sets should be as 'pure' as possible. Every effort should be made to ensure that anomalous data is not fed to the neural network during the training process. Since the buildup of plaque is considered one of the hallmarks of AD, presumed AD subjects with Aβ1-42 > 192pg/mL will be designated as non-specific dementia subjects and used for Specific Aim II.
|
Device: COGNISION™ System (Validating device only not intended for diagnosis)
30 mintue ERP test performed on well patient volunteers to validate EEG brainwaves and there correlation to behavioral and biomarkers for detailed validation.
|
|
AD Group MEDS
Half of the AD subjects in the AD cohort will be on cholinesterase inhibitor (AChEI) therapy. For the purpose of this study, subjects in the AD cohort matching all of the above criteria and having Aβ1-42 > 192pg/mL (Leslie Shaw, PhD, University of Pennsylvania, personal communications) will be considered as subjects with 'Non-specific dementia'. In neural network theory, the data used to form the training sets should be as 'pure' as possible. Every effort should be made to ensure that anomalous data is not fed to the neural network during the training process. Since the buildup of plaque is considered one of the hallmarks of AD, presumed AD subjects with Aβ1-42 > 192pg/mL will be designated as non-specific dementia subjects and used for Specific Aim II.
|
Device: COGNISION™ System (Validating device only not intended for diagnosis)
30 mintue ERP test performed on well patient volunteers to validate EEG brainwaves and there correlation to behavioral and biomarkers for detailed validation.
|
The study will be :
A. Multi-Center Study:
A primary goal of this study will be to evaluate the COGNISION™ platform across multiple study locations. This will demonstrate an ability to perform tests, collect data, and generate classifications irrespective of variations in testing locations and personnel.
Eligibility| Ages Eligible for Study: | 60 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Subjects between 60 and 85 years old meeting DSM-IV criteria for dementia of the Alzheimer's type and NINCDS-ADRDA criteria for probable AD will be recruited in the AD cohort. (MMSE >16, <24)The cohort of AD patients will be evenly divided between cholinesterase-inhibitor-naïve patients and patients on cholinesterase inhibitors.
Inclusion Criteria:
AD Cohort:
Normal Controls:
Normal memory function will be documented by scoring at specific cutoffs on the Logical Memory II subscale (delayed Paragraph Recall) from the Wechsler Memory Scaled - Revised (the maximum score is 25):
Exclusion Criteria:
AD Cohort:
Normal Controls exclusions:
NOTE: If a subject that is tested under the presumed "normal control" has a rating on the MMSE lower than 24, this subject should then be evaluated for inclusion in the AD cohort and validated per protocol.
Contacts and Locations| Contact: KC Fadem, MS | 502-609-1411 | kfadem@neuronnetrix.com |
| Contact: Mauktik Kulknari, MS | 502-212-2493 | Mkulknari@neuronetrix.com |
| United States, Kentucky | |
| Sanders Brown Center on Aging | |
| Lexington, Kentucky, United States, 40536 | |
| Principal Investigator: | Charles D Smith, M. D. | Univeristy of Kentucky- Sanders-Brown Center of Aging |
More Information
| Responsible Party: | University of Kentucky ( Dr. Charles Smith ) |
| Study ID Numbers: | VAL-UK-DUKE-TMC-PMD |
| Study First Received: | July 13, 2009 |
| Last Updated: | July 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00938665 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Alzheimer Memory disorder dementia |
cognitive behavioral decline vascular dementia front temporal dementia |
|
Pick Disease of the Brain Speech Disorders Aphasia Primary Progressive Aphasia Alzheimer Disease Language Disorders Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Aphasia, Primary Progressive Memory Disorders Cognition Disorders |
Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Frontotemporal Dementia Mental Disorders Neurologic Manifestations Dementia, Vascular Dementia Neurobehavioral Manifestations Lobar Atrophy of Brain Communication Disorders Delirium |
|
Pick Disease of the Brain Speech Disorders Aphasia Alzheimer Disease Nervous System Diseases Language Disorders Central Nervous System Diseases Brain Diseases Neurodegenerative Diseases Memory Disorders |
Aphasia, Primary Progressive Cognition Disorders Signs and Symptoms Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Neurologic Manifestations Dementia Tauopathies Neurobehavioral Manifestations Communication Disorders |
