- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00938665
Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease. (COGNISION™)
Study Overview
Status
Intervention / Treatment
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Florida
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West Palm Beach, Florida, United States, 33407
- Premiere Research Institute
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Kentucky
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Lexington, Kentucky, United States, 40536
- University of Kentucky
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Louisville, Kentucky, United States, 40202
- Norton Healthcare
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Massachusetts
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Brookline, Massachusetts, United States, 02467
- Boston Center for Memory
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- University of Pennsylvania
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Vermont
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Bennington, Vermont, United States, 05201
- The Memory Clinic
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Control Group
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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.
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AD Group
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Electrophysiological markers of cognitive status
Time Frame: Markers are collected at study visit
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Markers are collected at study visit
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Murali Doraiswamy, MD, Duke University
- Principal Investigator: Charles D Smith, MD, Univeristy of Kentucky
- 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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Metabolic Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Neurocognitive Disorders
- Neurodegenerative Diseases
- TDP-43 Proteinopathies
- Proteostasis Deficiencies
- Tauopathies
- Language Disorders
- Communication Disorders
- Speech Disorders
- Frontotemporal Lobar Degeneration
- Aphasia
- Dementia
- Alzheimer Disease
- Frontotemporal Dementia
- Aphasia, Primary Progressive
- Pick Disease of the Brain
- Memory Disorders
Other Study ID Numbers
- SRP-1418
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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