Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease. (COGNISION™)
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| ClinicalTrials.gov Identifier: NCT00938665 |
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Recruitment Status :
Completed
First Posted : July 14, 2009
Last Update Posted : March 10, 2014
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| Condition or disease | Intervention/treatment |
|---|---|
| Memory Disorders Alzheimer Disease Dementia Cognitive Impairment Frontotemporal Dementia | Device: COGNISION™ System |
The study will be :
A. Multi-Center Study:
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.
- 5-8 study sites will be selected with each site being a recognized NIH Center of Excellence for Alzheimer's disease or other nationally recognized Alzheimer's disease research center.
- Each site will evaluate up to 60 subjects evenly divided between AD patients and age-matched controls (while the prevalence of AD is approximately 2% in the general population, the ratio of AD to normal among those who visit a clinic for memory or cognitive related issues is between 50-60%).
- Each site will follow the same testing protocols.
- All test data will be uploaded to the online COGNISION™ database server.
| Study Type : | Observational |
| Actual Enrollment : | 204 participants |
| Observational Model: | Case Control |
| Time Perspective: | Cross-Sectional |
| Official Title: | Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease. |
| Study Start Date : | December 2010 |
| Actual Primary Completion Date : | February 2014 |
| Actual Study Completion Date : | February 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
| Control Group |
Device: COGNISION™ System
30 minute ERP test and 3 minute resting EEG data collected from cognitively healthy and AD to validate ERP and qEEG as useful cognitive biomarkers for AD. |
| AD Group |
Device: COGNISION™ System
30 minute ERP test and 3 minute resting EEG data collected from cognitively healthy and AD to validate ERP and qEEG as useful cognitive biomarkers for AD. |
- Electrophysiological markers of cognitive status [ Time Frame: Markers are collected at study visit ]
Biospecimen Retention: Samples Without DNA
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These lab tests will be performed from a standard blood draw:
- B12
- TSH
- CRP
- ALT
- HGB
- Hgb1AC
- T4
- K
- Cl
- CO2
- ApoE
- Platelet Count
- INR
- PT
- MRI- INCLUDING VOLUMETRY
- CSF 5ML (Optional)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 60 Years to 90 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
AD Cohort:
Subjects between 60 and 90 years old meeting NINCDS-ADRDA criteria for probable AD2 and DSM-IV criteria for dementia of the Alzheimer's type3 will be recruited in the AD cohort (MMSE ≥21, ≤26).
Memory complaint by subject and/or study partner SRP-1418 N Page: 8 of 26
Abnormal memory function score on Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (adjusted for education. Maximum score is 25):
i. < 10 for 16 or more years of education ii. < 6 for 8-15 years of education iii. < 4 for 0-7 years of education Clinical Dementia Rating (CDR) = 0.5, 1.0 or 2.0 Modified Hachinski Ischemic Scale (HIS) ≤ 4 Geriatric Depression Scale (GDS) < 6 For subjects that decide to provide a CSF sample: Platelet count ≥ 100,000/μL, Prothrombin Time (PT) = 11 to 16 seconds, International Normalized Ratio = 0.8 to 1.2 Study partner or caregiver to accompany subject to all scheduled visits Fluent in English Adequate visual acuity to allow neuropsychological testing Adequate auditory acuity to allow neuropsychological and ERP testing Good general health with no additional diseases expected to interfere with the study Willing to undergo neuroimaging and provide blood. The subject may optionally provide a CSF sample by lumbar puncture.
Normal Controls:
Healthy subjects matched for age, gender, and education level will be recruited as normal controls (MMSE ≥ 27).
Normal memory function will be documented by scoring at specific cutoffs on the
Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler Memory Scale - Revised:
i. ≥ 10 for 16 or more years of education ii. ≥ 6 for 8-15 years of education iii. ≥ 4 for 0-7 years of education Study partner or caregiver Fluent in English Adequate visual acuity to allow neuropsychological testing Adequate auditory acuity to allow neuropsychological and ERP testing
Exclusion Criteria:
AD Cohort:
Severe or unstable forms of diabetes, heart disease, HIV, drug or alcohol abuse, etc. including severe AD: MMSE ≤20 Platelet count < 100,000/μL, Prothrombin Time (PT) > 16 seconds, International Normalized Ratio > 1.2 (for subjects that choose to provide a CSF sample by lumbar puncture).
Medical or psychiatric disorders that might complicate the assessment of dementia (i.e., mental retardation, alcohol abuse, drug abuse, HIV) A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, language difficulty) Recent intake of drugs known to cause major organ system toxicity or CNS alteration (e.g. sedation) Diseases of the dementia type other than AD (i.e., vascular dementia, frontotemporal dementia, Lewy Body Disease, Huntington's disease) Presence of non-MRI compatible implants/devices Prohibited Medications: Warfarin or other anticoagulants (for subjects that choose to provide a CSF sample by lumbar puncture), investigational agents.
Normal Controls:
Severe or unstable forms of diabetes, heart disease, HIV, drug or alcohol abuse, etc.
A disability that may prevent the subject from completing all study requirements (e.g., blindness, deafness, language difficulty) Use of psychoactive drugs (only SSRI's are allowed) Psychiatric disorders (schizophrenia, bipolar, etc.) Depression (GDS > 6) Vascular dementia (HIS > 4) Other dementia (CDR > 0)
Abnormal memory function score on Wechsler Memory Scale -Logical Memory II subscale (delayed Paragraph Recall) from the Wechsler Memory Scale - Revised (the maximum score is 25):
I. < 10 for 16 or more years of education II. < 6 for 8-15 years of education III. < 4 for 0-7 years of education
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00938665
| United States, Florida | |
| Premiere Research Institute | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Kentucky | |
| University of Kentucky | |
| Lexington, Kentucky, United States, 40536 | |
| Norton Healthcare | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Massachusetts | |
| Boston Center for Memory | |
| Brookline, Massachusetts, United States, 02467 | |
| United States, North Carolina | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Vermont | |
| The Memory Clinic | |
| Bennington, Vermont, United States, 05201 | |
| Principal Investigator: | Charles D Smith, MD | Univeristy of Kentucky | |
| Principal Investigator: | Murali Doraiswamy, MD | Duke University | |
| Principal Investigator: | Steven E Arnold, MD | University of Pennsylvania | |
| Principal Investigator: | Paul R Solomon, PhD | The Memory Clinic, Bennington VT | |
| Principal Investigator: | Bradley S Folley, PhD | Norton Healthcare, Louisville KY | |
| Principal Investigator: | Carl Sadowsky, MD | Premiere Research Institute, West Palm Beach FL | |
| Principal Investigator: | Andrew E Budson, MD | Boston Center for Memory |
| Responsible Party: | Neuronetrix, Inc. |
| ClinicalTrials.gov Identifier: | NCT00938665 History of Changes |
| Other Study ID Numbers: |
SRP-1418 |
| First Posted: | July 14, 2009 Key Record Dates |
| Last Update Posted: | March 10, 2014 |
| Last Verified: | March 2014 |
Keywords provided by Neuronetrix, Inc.:
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Alzheimer Memory disorder dementia |
cognitive behavioral decline vascular dementia front temporal dementia |
Additional relevant MeSH terms:
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Alzheimer Disease Dementia Cognitive Dysfunction Frontotemporal Dementia Aphasia, Primary Progressive Pick Disease of the Brain Memory Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders |
Mental Disorders Cognition Disorders Frontotemporal Lobar Degeneration TDP-43 Proteinopathies Proteostasis Deficiencies Metabolic Diseases Aphasia Speech Disorders Language Disorders Communication Disorders Neurobehavioral Manifestations Neurologic Manifestations Signs and Symptoms |