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Clinical Trial Details

Overview

Research Study Summary

Patients are needed to participate in a clinical research study of COGNISION™ System

Research Study Title

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

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.

To Learn more
Gender

Both Male and Female

Age

60 to 90 Years

Overall Status

Recruiting

Lead Sponsor

Neuronetrix, Inc.

Duration

30 Months

Facility Type

N/A

Eligibility

Both Male and Female ages 60 Years to 90 Years

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

Site Locations (7)

Country State City Zip Facility and Contact
United States Florida West Palm Beach 33407 Premiere Research Institute
Teresa Villena, MD
561-845-0500 ext. 124
tvillena@aol.com
United States Kentucky Lexington 40536 University of Kentucky
Dorothy Ross, CCRP
859-323-2737
dross3@email.uky.edu
United States Kentucky Louisville 40202 Norton Healthcare
Anne J Watson
502-629-5270
Anne.Watson@nortonhealthcare.org
United States Massachusetts Brookline 02467 Boston Center for Memory
Sumati Raghavan, MD
617-699-6927
sumati@bostonmemory.com
United States North Carolina Durham 27710 Duke University
Caroline A Hellegers, MA
919-681-3986
helle003@mc.duke.edu
United States Pennsylvania Philadelphia 19104 University of Pennsylvania
Peter Janis
215-573-4443
Peter.Janis@uphs.upenn.edu
United States Vermont Bennington 05201 The Memory Clinic
Diana Michalczuk, PsyD
802-447-1409 ext. 18
diana@memorydoc.org

Contact

KC Fadem
502-561-9040 ext. 7001

If you would like to learn more about participating in this research study, please email the trial contact using the form below.

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NCT ID: NCT00938665

Date Last Changed: December 26, 2012

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