Longitudinal Validation of a Computerized Cognitive Battery (Cognigram) in the Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- CG scores (accuracy and reaction speed)
研究概览
简要总结
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:
- 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.
详细描述
Rationale
Today's aging population brings an increase in the incidence of dementia. In Canada, there are approximately 564,000 persons diagnosed with dementia, with an expected two-fold increase in this number by the year 2031. In this context, the early detection and prediction of cognitive decline are both imperative for achieving the prevention and/or slowing of dementia.
Standard pencil-and-paper neuropsychological tests are pivotal for the detection and follow-up of cognitive impairment; however they are labor-intensive and require the presence of a trained neuropsychologist on-site. In this regard, computerized testing may be better suited for cognitive screening in large epidemiologic studies and for longitudinal monitoring by primary care providers, due to their higher efficiency for serial assessments and their suitability for off-site or long-distance use. At the same time, computerized testing allows for higher precision in the recording of accuracy and speed of response, with a level of sensitivity not possible in standard administrations.
A number of computerized cognitive batteries have been recently developed, though intended as research tools. There is a current demand for the validation of computerized cognitive batteries in the clinical setting. One such computerized battery is the Cognigram™ (CG), which measures processing speed, attention, working memory and learning. Previous cross-sectional studies have demonstrated the validity of CG for detecting MCI and various types of dementia. However, there is no current literature on the longitudinal validity of CG, and minimal longitudinal validation of other computerized cognitive batteries currently in existence.
On the other hand, research and medicine is moving away from behavioral responses to assess brain health (e.g. verbal responses, reaction time, etc.) and are moving toward more neuroimaging focused measures. Biological tests could enable to detect pre-dementia and determine the prognosis of MCI subjects.A promising biological test is EEG/ERP. The investigators have previously shown group differences in ERPs for patients with MCI and CN. Other studies have reported promising ERP markers of pre-dementia and progression of MCI to dementia. However, ERP can be complex to process and labor-intensive, limiting its value in the clinical setting. For example, the usual time for an ERP series measuring multiple cognitive domains typically lasts 1 hour, another 25 minutes for applying the EEG cap and ensuring all electrodes are connected, and some 30 minutes per paradigm (x2-3 paradigms).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
CG scores (accuracy and reaction speed)
时间窗: 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).
MoCA scores
时间窗: Baseline visit during year 1
The total score is 30 points; a score of 26 or above is considered normal.
ERP´s amplitudes for Auditory sensation (N100)
时间窗: Baseline visit during year 1
mean and standard deviation in microvolt (μV).
ERP´s amplitude for Cognitive processing (N400)
时间窗: Baseline visit during year 1
mean and standard deviation in microvolt (μV)
ERP´s amplitude for Basic Attention (P300)
时间窗: Baseline visit during year 1.
mean and standard deviation in microvolt (μV)
ERP´s latency for Auditory sensation (N100)
时间窗: Baseline visit during year 1.
means and standard deviations in milliseconds (ms).
ERP´s latency for Cognitive processing (N400)
时间窗: Baseline visit during year 1.
means and standard deviations in milliseconds (ms).
ERP´s latency for Basic Attention (P300)
时间窗: Baseline visit during year 1.
means and standard deviations in milliseconds (ms).
Longitudinal changes in CG scores
时间窗: 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.
Longitudinal changes in MoCA scores
时间窗: 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.
Longitudinal change in Mini-mental state examination (MMSE)
时间窗: 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.
Longitudinal change in FAQ
时间窗: 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.
Longitudinal change in GPCOG scores
时间窗: 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).
Longitudinal change in Trail Making Tests A and B
时间窗: 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.
Longitudinal change in Rey-Osterrieth Complex Figure test (RCFT)
时间窗: 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).
Longitudinal change in Hopkins Verbal Learning test (HVLT-R)
时间窗: 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).
Longitudinal change in Semantic Verbal Fluency test (animals).
时间窗: 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.
Longitudinal change in ERP´s amplitudes for Auditory sensation (N100)
时间窗: baseline, 6 months, 12 months, 24 months, and 36 months follow ups.
Change is being assessed. Means and standard deviations in microvolt (μV).
Longitudinal change in ERP´s amplitudes for Cognitive processing (N400)
时间窗: baseline, 6 months, 12 months, 24 months, and 36 months follow ups.]
Change is being assessed. Means and standard deviations in microvolt (μV).
Longitudinal change in ERP´s amplitudes for Basic Attention (P300)
时间窗: baseline, 6 months, 12 months, 24 months, and 36 months follow ups.]
Change is being assessed. Means and standard deviations in microvolt (μV).
Longitudinal change in ERP´s latencies for Auditory sensation (N100)
时间窗: baseline, 6 months, 12 months, 24 months, and 36 months follow ups
Change is being assessed. Means and standard deviations in milliseconds (ms).
Longitudinal change in ERP´s latencies for Cognitive processing (N400)
时间窗: baseline, 6 months, 12 months, 24 months, and 36 months follow ups
Change is being assessed. Means and standard deviations in milliseconds (ms).
Longitudinal change in ERP´s latencies for Basic Attention (P300)
时间窗: baseline, 6 months, 12 months, 24 months, and 36 months follow ups
Change is being assessed. Means and standard deviations in milliseconds (ms).
次要结局
未报告次要终点
研究者
Frank Knoefel
Physician, Bruyère Memory Program, Bruyère Continuing Care; Assistant professor, University of Ottawa
Bruyere Research Institute