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

NCT03676881 | Unknown

• 1 other identifier: M16-17-032)
• Study Type: observational
• Target: 36
• Locations: 1 country
• Sites: 1

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. 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.
2. 2.The NeuroCatch™ Platform (NCP)

Conditions

Alzheimer Disease; Dementia; Neuropathology; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (23)

• CG scores (accuracy and reaction speed)

  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).

  Baseline visit during year 1

• MoCA scores

  The total score is 30 points; a score of 26 or above is considered normal.

  Baseline visit during year 1

• ERP´s amplitudes for Auditory sensation (N100)

  mean and standard deviation in microvolt (μV).

  Baseline visit during year 1

• ERP´s amplitude for Cognitive processing (N400)

  mean and standard deviation in microvolt (μV)

  Baseline visit during year 1

• ERP´s amplitude for Basic Attention (P300)

  mean and standard deviation in microvolt (μV)

  Baseline visit during year 1.

• ERP´s latency for Auditory sensation (N100)

  means and standard deviations in milliseconds (ms).

  Baseline visit during year 1.

• ERP´s latency for Cognitive processing (N400)

  means and standard deviations in milliseconds (ms).

  Baseline visit during year 1.

• ERP´s latency for Basic Attention (P300)

  means and standard deviations in milliseconds (ms).

  Baseline visit during year 1.

• Longitudinal changes in CG scores

  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.

  Complete 3 year period

• Longitudinal changes in MoCA scores

  The total score is 30 points; a score of 26 or above is considered normal. Scores over the three year period will be compared.

  Complete 3 year period

• Longitudinal change in Mini-mental state examination (MMSE)

  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.

  baseline, 12 months, 24 months, and 36 months follow ups

• Longitudinal change in FAQ

  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.

  baseline 12 months, 24 months, and 36 months follow ups

• Longitudinal change in GPCOG scores

  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).

  baseline 12 months, 24 months, and 36 months follow ups

• Longitudinal change in Rey-Osterrieth Complex Figure test (RCFT)

  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).

  baseline, 12 months, 24 months, and 36 months follow ups

• Longitudinal change in Hopkins Verbal Learning test (HVLT-R)

  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).

  baseline, 12 months, 24 months, and 36 months follow ups

• Longitudinal change in Trail Making Tests A and B

  Change is being assessed.Trail making A \& B average time is 29 \& 75 seconds, \>78 \& \>273 seconds considered deficient, respectively.

  baseline, 12 months, 24 months, and 36 months follow ups

• Longitudinal change in Semantic Verbal Fluency test (animals).

  Change is being assessed. Semantic verbal fluency on animals based on most productive number of animals named in 60 seconds.

  baseline, 12 months, 24 months, and 36 months follow ups

• Longitudinal change in ERP´s amplitudes for Auditory sensation (N100)

  Change is being assessed. Means and standard deviations in microvolt (μV).

  baseline, 6 months, 12 months, 24 months, and 36 months follow ups.

• Longitudinal change in ERP´s amplitudes for Cognitive processing (N400)

  Change is being assessed. Means and standard deviations in microvolt (μV).

  baseline, 6 months, 12 months, 24 months, and 36 months follow ups.]

• Longitudinal change in ERP´s amplitudes for Basic Attention (P300)

  Change is being assessed. Means and standard deviations in microvolt (μV).

  baseline, 6 months, 12 months, 24 months, and 36 months follow ups.]

• Longitudinal change in ERP´s latencies for Auditory sensation (N100)

  Change is being assessed. Means and standard deviations in milliseconds (ms).

  baseline, 6 months, 12 months, 24 months, and 36 months follow ups

• Longitudinal change in ERP´s latencies for Cognitive processing (N400)

  Change is being assessed. Means and standard deviations in milliseconds (ms).

  baseline, 6 months, 12 months, 24 months, and 36 months follow ups

• Longitudinal change in ERP´s latencies for Basic Attention (P300)

  Change is being assessed. Means and standard deviations in milliseconds (ms).

  baseline, 6 months, 12 months, 24 months, and 36 months follow ups

Study Arms (2)

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); Device: The NeuroCatch™ Platform (NCP)

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); Device: The NeuroCatch™ Platform (NCP)

Interventions

Computerized cognitive battery: Cognigram (CG) DEVICE

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.

Cognitively normal subjects (CN); Mild Cognitive Impairment (MCI)

The NeuroCatch™ Platform (NCP) DEVICE

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); Mild Cognitive Impairment (MCI)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Bruyère Health Research Institute.: lead

Study Sites (1)

Bruyere Research Institute

Ottawa, Ontario, K1N 5C8, Canada

Location

Related Publications (21)

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MeSH Terms

Conditions

Alzheimer Disease; Dementia; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders

Study Officials

• Frank Frank, MD

  Bruyère Health Research Institute.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Bruyère Memory Program, Bruyère Continuing Care; Assistant professor, University of Ottawa

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: September 19, 2018
• Study Start: September 4, 2018
• Primary Completion: December 1, 2021
• Study Completion: December 1, 2021
• Last Updated: January 14, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)