COGNISION™ as a Useful Cognitive Biomarker for Alzheimer's Disease
COGNISION™ as a Useful Cognitive Biomarker for Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
The proposed study is designed to evaluate the performance of the COGNISION™ system as a tool to assist physicians in diagnosing Alzheimer's disease in real-world clinical settings.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
60 Years | 90 Years | Both | Yes |
Inclusion Criteria:
- Age 60-90
- Meet criteria for probable Alzheimer's disease, with memory complaint by subject and/or study partner
- Clinical Dementia Rating (CDR) = 0.5, 1.0 or 2.0; Modified Hachinski Ischemic Scale ≤4; Geriatric Depression Scale <6
- Study partner or caregiver to accompany subject to all scheduled visits
- Fluent in English
- Adequate seeing and hearing ability to allow neuropsychological testing
- Good general health with no additional diseases expected to interfere with the study
- Normal memory function
- Fluent in English
- Adequate seeing and heairng ability to allow neuropsychological testing
Participants with Alazheimer's Disease
Normal Controls
Exclusion Criteria:
- Severe or unstable medical conditions (e.g., diabetes, heart disease, HIV, drug or alcohol abuse)
- Severe Alzheimer's disease (MMSE ≤20) or other dementias
- Medical or psychiatric disorders that might complicate the assessment of dementia (i.e., mental retardation, alcohol abuse, drug abuse, HIV)
- Disability that may prevent the subject from completing all study requirements
- Recent intake of drugs known to cause major organ system toxicity or central nervous system alteration
- Presence of non-MRI compatible implants/devices
- Prohibited medications: Investigational agents
- Severe or unstable medical conditions (e.g., diabetes, heart disease, HIV, drug or alcohol abuse)
- Disability that may prevent the subject from completing all study requirements
- Use of psychoactive drugs (only SSRIs are allowed)
- Psychiatric disorders, depression, dementia
- Abnormal memory function
- Prohibited medications: Psychoactive drugs
Participants with Alzheimer's Disease
Normal Controls
Detailed Description:
The primary goals of this study are to evaluate the COGNISION system's ability to perform tests, collect data, and diagnose AD. COGNISION is a noninvasive electroencephalographic (EEG) device that measures electrical signals at the scalp. The brain produces these signals when performing tasks called "event-related potentials," or ERP. In this study, investigators will determine whether the electrical signal "signatures" of Alzheimer's disease can be distinguished from normal brain signals to permit a diagnosis of dementia.
During the 45- to 60-minute ERP procedure, participants will wear headphones and electrodes. They will respond to a series of tones and perform other exercises. Each study site will evaluate between 25 and 50 individuals, evenly divided between people with Alzheimer's and age-matched controls. The cohort of Alzheimer's patients will be evenly divided between individuals who do and do not take cholinesterase inhibitors.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 26.7619563, -80.1037721 | Premiere Research Institute | West Palm Beach | Florida | 33407 | Recruiting | Teresa Villena 561-845-0500 x124 tvillena@aol.com |
Geolocation is 38.0328237, -84.5067424 | University of Kentucky | Lexington | Kentucky | 40536 | Recruiting | Dorothy Ross 859-323-2737 dross3@email.uky.edu |
Geolocation is 38.2556928, -85.751283 | Norton Healthcare | Louisville | Kentucky | 40202 | Recruiting | Anne J. Watson 502-629-5270 Anne.Watson@nortonhealthcare.org |
Geolocation is 42.3178198, -71.1626756 | Boston Center for Memory | Brookline | Massachusetts | 02467 | Recruiting | Sumati Raghavan 617-699-6927 sumati@bostonmemory.com |
Geolocation is 36.0038131, -78.9387241 | Duke University | Durham | North Carolina | 27710 | Recruiting | Caroline A. Hellegers 919-681-3986 helle003@mc.duke.edu |
Geolocation is 39.9583587, -75.1953934 | University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting | Peter Janis 215-573-4443 Peter.Janis@uphs.upenn.edu |
Geolocation is 42.878094, -73.1968001 | The Memory Clinic | Bennington | Vermont | 05201 | Recruiting | Diana Michalczuk 802-447-1409 x18 diana@memorydoc.org |
Lead Sponsor:
| Agency |
|---|
Neuronetrix, Inc. |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Charles D. Smith, MD | Principal Investigator | Univeristy of Kentucky |
Murali Doraiswamy, MD | Principal Investigator | Duke University |
Steven E. Arnold, MD | Principal Investigator | University of Pennsylvania |
Paul R. Solomon, PhD | Principal Investigator | The Memory Clinic, Bennington VT |
Bradley S. Folley, PhD | Principal Investigator | Norton Healthcare, Louisville KY |
Carl Sadowsky, MD | Principal Investigator | Premiere Research Institute, West Palm Beach FL |
Andrew E. Budson, MD | Principal Investigator | Boston Center for Memory |
Study Contact:
| Name | Phone | Phone Ext | |
|---|---|---|---|
KC Fadem | 502-561-9040 | x108 |
Locations
ClinicalTrials.gov ID
NCT00938665 (follow link to view full record on ct.gov in new window)
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
Study End Date:
September 2013
Disease Stage:
Early
Middle
Enrollment:
200
