Evaluation of a Handheld Event Related Potential (ERP)/Quantitative Electroencephalography (qEEG) System (COGNISION™) as a Useful Cognitive Biomarker for Alzheimer's Disease.

NCT00938665 | Completed

• 1 other identifier: SRP-1418
• Study Type: observational
• Target: 204
• Locations: 1 country
• Sites: 7

Brief Summary

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.

Conditions

Memory Disorders; Alzheimer Disease; Dementia; Cognitive Impairment; Frontotemporal Dementia

Keywords

Alzheimer; Memory disorder; dementia; cognitive behavioral decline; vascular dementia; front temporal dementia

Outcome Measures

Primary Outcomes (1)

• Electrophysiological markers of cognitive status

  Markers are collected at study visit

Study Arms (2)

Control Group

Device: COGNISION™ System

AD Group

Device: COGNISION™ System

Interventions

COGNISION™ System DEVICE

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; Control Group

Eligibility Criteria

• Age: 60 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects between 60 and 90 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. Matched cognitively healthy volunteers will be recruited for the Control group.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neuronetrix, Inc.: lead

Study Sites (7)

Premiere Research Institute

West Palm Beach, Florida, 33407, United States

Location

University of Kentucky

Lexington, Kentucky, 40536, United States

Location

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

Boston Center for Memory

Brookline, Massachusetts, 02467, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

The Memory Clinic

Bennington, Vermont, 05201, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. These lab tests will be performed from a standard blood draw: 1. B12 2. TSH 3. CRP 4. ALT 5. HGB 6. Hgb1AC 7. T4 8. Na 9. K 10. Cl 11. CO2 12. ApoE 13. Platelet Count 14. INR 15. PT 2. MRI- INCLUDING VOLUMETRY 3. CSF 5ML (Optional)

MeSH Terms

Conditions

Memory Disorders; Alzheimer Disease; Dementia; Cognitive Dysfunction; Frontotemporal Dementia; Dementia, Vascular

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Frontotemporal Lobar Degeneration; TDP-43 Proteinopathies; Proteostasis Deficiencies; Metabolic Diseases; Nutritional and Metabolic Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2009
• First Posted: July 14, 2009
• Study Start: December 1, 2010
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: March 10, 2014

Record last verified: 2014-03

Locations

US (7)