Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
NCT03676881 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 36
Last updated 2020-01-14
Summary
This research project will test two new computerized technologies in the detection of brain changes related to Mild Cognitive Impairment (MCI) and dementia due to Alzheimer's disease. These technologies are:
1. Computerized cognitive battery: Cognigram (CG) Computerized assessments have multiple advantages for the early detection of subtle changes in cognition in older adults. One of their main advantages is their higher precision when measuring accuracy and speed of responses, compared to pencil-and-paper tests. They also allow a greater reliability in measures, as tests are given in a standardized format without the interference of an evaluator. Finally, by including automatized instructions and reports, they are suitable for off-site or long-distance use.
The present study aims to validate the Cognigram™ (CG) computerized cognitive tool, in a prospective and longitudinal fashion, determining if changes in the CG scores over 3, 6, 9, and 12 months, can predict progression to dementia at 1-year, 2-years, and 3-years, for patients with Mild Cognitive Impairment (MCI).
2. The NeuroCatch™ Platform (NCP)
Event-related potentials (ERP) are non-invasive, low-cost, electrophysiological methods that allow recording of the electrical activity of the brain in vivo through an Electroencephalogram (EGG). They are free from cultural and educational influence and can provide insights into the cognitive processes. ERP could enable to detect brain changes and determine the prognosis of MCI subjects.
The NCP, an investigational medical device system developed by NeuroCatch Inc., consists of an EEG software and hardware that captures brain health information. It offers a quick (i.e., 10 minutes for EEG preparation and 6 minutes for each task of EEG recording), simple (i.e., includes only 8 electrodes), and easy-to-use solution (i.e., includes a computerized software that automatically analyzes data and outputs graphs in less than 1 minute) for the acquisition of EEG and ERP.
Conditions
- Alzheimer Disease
- Dementia
- Neuropathology
- Mild Cognitive Impairment
Interventions
- DEVICE
-
Computerized cognitive battery: Cognigram (CG)
is a validated, computerized battery of cognitive tasks based on card games, developed by Cogstate Ltd. This technology includes four tasks, with a total duration of 10-15 minutes. The subject is asked to answer each task by pressing either 'D' or 'K' keyboard buttons. The technology supports the measurement of attention/vigilance, processing speed, concentration, visual working memory and visual recognition memory. The software will run on a computer supplied by the Bruyère Research Institute, in a private test room. The RA will be present during the testing session, reading out loud the batteries standardized instructions and doing the practice trials with the participants. After the practice trials, the RA will not give any feedback or support.
- DEVICE
-
The NeuroCatch™ Platform (NCP)
the NCP includes 6 stimulus sequences specifically designed to elicit desired brain responses. Each sequence contains both the oddball task and semantic word-pair task, and lasts 6 minutes. In our protocol, two sequences will be used. For the setup, EEG electrodes are placed on the participant's scalp, and the EEG signal quality is ensured by gently abrading the skin beneath each of the electrodes. A conductive gel is then placed between the skin and the electrode. Most electrodes are contained in an elastic cap, which is worn by the participants, but some electrodes are attached to the skin with adhesive. This part of the session takes around 10 minutes. EEG scan will commence once the setup is completed. Two auditory scans of 6 minutes each, separated by a one-minute break, will be administered. The total time of EEG testing for participants, including setup, will be of ≈25 minutes.
Sponsors & Collaborators
-
Bruyère Health Research Institute.
lead OTHER
Principal Investigators
-
Frank Frank, MD · Bruyère Health Research Institute.
Eligibility
- Min Age
- 60 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-09-04
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
Countries
- Canada
Study Locations
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