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Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease

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ClinicalTrials.gov Identifier: NCT03676881
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : September 19, 2018
Sponsor:
Information provided by (Responsible Party):
Frank Knoefel, Bruyere Research Institute

Brief 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.


Condition or disease Intervention/treatment
Alzheimer Disease Dementia Neuropathology Mild Cognitive Impairment Device: Computerized cognitive battery: Cognigram (CG) Device: The NeuroCatch™ Platform (NCP)

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Actual Study Start Date : September 4, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Mild Cognitive Impairment (MCI)
30 MCI patients their study partners will be part of the 'Computerized cognitive battery- Cognigram (CG) project and 30 MCI with their study partners will be part of The NeuroCatch™ Platform (NCP) project.
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.

Cognitively normal subjects (CN)
30 CN participants who are cognitively normal that will be part of the 'Computerized cognitive battery- Cognigram (CG) project and 30 CN will be part of The NeuroCatch™ Platform (NCP) project.
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.




Primary Outcome Measures :
  1. CG scores (accuracy and reaction speed) [ Time Frame: Baseline visit during year 1 ]
    The standard scores are presented on a linear scale ranging between 0-150. This scale is broken down into three categories that reflect performance: Normal (90-150), Borderline (80-89), Abnormal (0-79).

  2. MoCA scores [ Time Frame: Baseline visit during year 1 ]
    The total score is 30 points; a score of 26 or above is considered normal.

  3. ERP´s amplitudes for Auditory sensation (N100) [ Time Frame: Baseline visit during year 1 ]
    mean and standard deviation in microvolt (μV).

  4. ERP´s amplitude for Cognitive processing (N400) [ Time Frame: Baseline visit during year 1 ]
    mean and standard deviation in microvolt (μV)

  5. ERP´s amplitude for Basic Attention (P300) [ Time Frame: Baseline visit during year 1. ]
    mean and standard deviation in microvolt (μV)

  6. ERP´s latency for Auditory sensation (N100) [ Time Frame: Baseline visit during year 1. ]
    means and standard deviations in milliseconds (ms).

  7. ERP´s latency for Cognitive processing (N400) [ Time Frame: Baseline visit during year 1. ]
    means and standard deviations in milliseconds (ms).

  8. ERP´s latency for Basic Attention (P300) [ Time Frame: Baseline visit during year 1. ]
    means and standard deviations in milliseconds (ms).

  9. Longitudinal changes in CG scores [ Time Frame: Complete 3 year period ]
    The standard scores are presented on a linear scale ranging between 0-150. This scale is broken down into three categories that reflect performance: Normal (90-150), Borderline (80-89), Abnormal (0-79). Scores over the three year period will be compared.

  10. Longitudinal changes in MoCA scores [ Time Frame: Complete 3 year period ]
    The total score is 30 points; a score of 26 or above is considered normal. Scores over the three year period will be compared.

  11. Longitudinal change in Mini-mental state examination (MMSE) [ Time Frame: baseline, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. MMSE - any score greater than or equal to 24 points (out of 30) indicates a normal cognition. Below this, scores can indicate severe (≤9 points), moderate (10-18 points) or mild (19-23 points) cognitive impairment.

  12. Longitudinal change in FAQ [ Time Frame: baseline 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. Sum scores (range 0-30). Cutpoint of 9 (dependent in 3 or more activities) is recommended to indicate impaired function and possible cognitive impairment.

  13. Longitudinal change in GPCOG scores [ Time Frame: baseline 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. A scale for rating the perceived impact of the cognitive difficulties in daily life functions. Ratings go from 0 (no interference) to 4 (extreme interference).

  14. Longitudinal change in Rey-Osterrieth Complex Figure test (RCFT) [ Time Frame: baseline, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed (copy, immediate and delayed recall). RCFT : scoring drawings based on the widely used 36-point scoring system. The same scoring criteria apply to all three drawing trials. Each of the 18 scoring units is scored based on accuracy and placement criteria. Unit scores range from two (accurately drawn, correctly placed) to zero (inaccurately drawn, incorrectly placed, unrecognizable, omitted).

  15. Longitudinal change in Hopkins Verbal Learning test (HVLT-R) [ Time Frame: baseline, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. HVLT-R : Raw scores are derived for Total score is the total correct recall of the 3 learning trials (3 trials, 12 items, max score = /36) (0-36), Delayed Recall is out of 12 (max 12) (0-12), Retention (percent retained) is the total recalled at delay (max 12) divided by the best score on trial 2 or 3. Score range is 0% or better. Recognition Discrimination Index is the number of hits minus the number of false positive identifications. Max score is 12 (ie 12 hits, no intrusions).

  16. Longitudinal change in Trail Making Tests A and B [ Time Frame: baseline, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed.Trail making A & B average time is 29 & 75 seconds, >78 & >273 seconds considered deficient, respectively.

  17. Longitudinal change in Semantic Verbal Fluency test (animals). [ Time Frame: baseline, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. Semantic verbal fluency on animals based on most productive number of animals named in 60 seconds.

  18. Longitudinal change in ERP´s amplitudes for Auditory sensation (N100) [ Time Frame: baseline, 6 months, 12 months, 24 months, and 36 months follow ups. ]
    Change is being assessed. Means and standard deviations in microvolt (μV).

  19. Longitudinal change in ERP´s amplitudes for Cognitive processing (N400) [ Time Frame: baseline, 6 months, 12 months, 24 months, and 36 months follow ups.] ]
    Change is being assessed. Means and standard deviations in microvolt (μV).

  20. Longitudinal change in ERP´s amplitudes for Basic Attention (P300) [ Time Frame: baseline, 6 months, 12 months, 24 months, and 36 months follow ups.] ]
    Change is being assessed. Means and standard deviations in microvolt (μV).

  21. Longitudinal change in ERP´s latencies for Auditory sensation (N100) [ Time Frame: baseline, 6 months, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. Means and standard deviations in milliseconds (ms).

  22. Longitudinal change in ERP´s latencies for Cognitive processing (N400) [ Time Frame: baseline, 6 months, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. Means and standard deviations in milliseconds (ms).

  23. Longitudinal change in ERP´s latencies for Basic Attention (P300) [ Time Frame: baseline, 6 months, 12 months, 24 months, and 36 months follow ups ]
    Change is being assessed. Means and standard deviations in milliseconds (ms).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

c) Diagnostic criteria:

Mild Cognitive Impairment (MCI):

Diagnosis of MCI in recruitment database and corroborated at baseline by:

  1. Objective cognitive impairment: expressed as ≥1.5 SD below the normative mean in at least one test of the NPS tests, AND
  2. MMSE >19, AND
  3. Subjective Cognitive Impairment, expressed by participant and/or study partner: defined by GPCOG, AND
  4. Absence of significant functional impairment: score ≤5 in the FAQ.

Cognitively Normal (CN):

Diagnosis of CN in recruitment database -or absence of diagnosis of MCI or dementia- and corroborated at baseline by:

  1. Normal score expressed as within 1 SD from the normative mean in every test of the NPS tests, AND
  2. MMSE ≥ 27
Criteria

Inclusion Criteria:

  • Age ≥ 60
  • Capable of giving consent, as stated by the University of California, San Diego Brief Assessment of Capacity to Consent (Appendix 9: UBACC)
  • Meeting the diagnostic criteria of MCI or CN (described below)
  • **For MCI subjects: availability of a Study partner, defined as a person that knows the participant for at least 5 years, has frequent contact with them (≥2 days/week) and is knowledgeable of their functioning in activities of daily living

Exclusion Criteria:

  • Significant visual, hearing, or hand-motor impairment that may interfere with the CG testing sessions or Neuropsychological Assessment
  • Currently participating in Clinical Drug Trials
  • Currently participating in multiple observational studies (≥2)
  • Meeting the DSM-IV criteria for dementia at baseline
  • Color blindness
  • No consent to UBACC administration in MCI subjects
  • Non-fluent in English
  • Active Major depression, Stroke, Traumatic Brain Injury, substance abuse, any other neurological disease (with the exception of MCI in the MCI group).
  • For NCP project only:

In-ear hearing aid or cochlear implant, hearing device

  • Implanted pacemaker
  • Metal or plastic implants in skull
  • History of seizures
  • Allergy to rubbing alcohol or EEG gel
  • Unhealthy scalp (apparent open wounds and/or bruised or weakened skin)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03676881


Contacts
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Contact: Frank Knoefel, MD 613-562-6262 ext 1357 tafeta@bruyere.org
Contact: Iman Sabra, Bsc 613-562-6262 ext 1266 isabra@bruyere.org

Locations
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Canada, Ontario
Bruyere Research Institute Recruiting
Ottawa, Ontario, Canada, K1N 5C8
Contact: Frank Knoefel, MD       tafeta@bruyere.org   
Contact: Iman Sabra, BSc    613-562-6262 ext 1247    isabra@bruyere.org   
Sponsors and Collaborators
Bruyere Research Institute
Investigators
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Principal Investigator: Frank Frank, MD Bruyere Research Institute
  Study Documents (Full-Text)

Documents provided by Frank Knoefel, Bruyere Research Institute:
Study Protocol  [PDF] August 29, 2018
Informed Consent Form  [PDF] August 29, 2018


Publications:
Maruff, P., Lim, Y. Y., Ames, D., Ellis, K., Pietrzak, R., Savage, G., ... & Villemagne, V. (2013). Clinical utility of the cogstate brief battery in Alzheimer's disease-related memory impairment. Alzheimer's & Dementia: The Journal of the Alzheimer's Association 9, 636-P637.
Lim, Y. Y., Villemagne, V. L., Pietrzak, R. H., Snyder, P. J., Ames, D., Ellis, K. A., ... & Maruff, P. (2014). Utility of the Cognigram brief battery in assessing cognitive changes associated with AB and APOE genotype in preclinical Alzheimer's Disease. Alzheimer's & Dementia: The Journal of the Alzheimer's Association, 10(4), 429-430.
American Psychiatric Association. (2000). Diagnostic and statistical manual of mental disorders (4th ed., text rev.). Washington, DC

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Responsible Party: Frank Knoefel, Physician, Bruyère Memory Program, Bruyère Continuing Care; Assistant professor, University of Ottawa, Bruyere Research Institute
ClinicalTrials.gov Identifier: NCT03676881     History of Changes
Other Study ID Numbers: M16-17-032)
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Only the EEG results will be shared with the manufacturer of the NeuroCatch Platform device (HealthTech Connex, Vancouver).

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders