A Comparative Study Between ViewMind AtlasTM, a Novel Digital Measure of Cognition, and Traditional Cognitive Tests
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 270
- 试验地点
- 2
- 主要终点
- Accuracy of ViewMind Atlas™ in Identifying Cognitive Impairment
研究概览
简要总结
The objective of this study is to demonstrate the clinical validity, analytical validity and safety of ViewMind Atlas as an adjunctive tool to be used by healthcare professionals (HCP) evaluating cognitive impairment in adults aged 45 to 95 years old.
详细描述
This will be a comparative study in which each subject undergoes testing by certified HCP evaluators administering the and ViewMind AtlasTM evaluation and the MoCA test, as well as additional tests, which are part of a reference standard neurocognitive battery of tests for cognition (WAT-BA, BEM-144, Rey Complex Figure Test, Wechsler Memory Scale subtests, WAIS III subtests, Trail Making Test A and B, Boston Naming Test, Phonological Verbal Fluency test, Semantic Verbal Fluency test, and Clock Drawing Test). Test-retest reliability of ViewMind AtlasTM will be conducted one week after initial testing.
Primary Objective:
● To assess the clinical validity of ViewMind Atlas for identifying cognitive impairment, as determined by MoCA
Secondary Objectives:
- To demonstrate the analytical validity of ViewMind Atlas for measuring cognition (evaluated) against an appropriate reference standard (MoCA)
- To examine the discriminant and convergence validity between ViewMind AtlasTM and a battery of neurocognitive tests in identifying cognitively healthy and cognitively impaired test subjects.
- To compare the test-retest reliability of ViewMind AtlasTM.
- To assess the safety of the ViewMind system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Male or female, aged between 45 and 95 years.
- •Cohort 1: Presence of cognitive complaints and objectively measured cognitive impairment of an MMSE of > 26, such as memory loss or other cognitive difficulties (60% of the overall study population). These complaints can be self-reported or noted by a close family member. Diagnosis of MCI by PI or delegated qualified provider on the study team.
- •Cohort 2: Absence of cognitive complaints and absence of objectively measured cognitive impairment as determined by MMSE > 26 and neuropsychological tests. Diagnosis of CN by PI or delegated qualified provider on the study team (40% of the overall study population).
- •Willing to sign written informed consent and ability to comply with study requirements.
- •Have adequate vision and hearing, with or without corrective devices, to ensure accurate self-reporting and comprehension of study materials.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Participants with dementia, defined here as an MMSE of < 25 and diagnosis of cognitive decline that is not MCI but more severe in nature by the PI or delegated qualified provider on the study team.
- •Advanced, severe progressive or unstable disease that may interfere with the safety, tolerability and study assessments, or put the participant at special risk as judged by the investigator.
- •Subjects who had received an investigational drug or therapy within 30 days or 5 half-lives, whichever was longer, of the first visit.
- •Participants with glaucoma, cataract, macular degeneration in both eyes, or any other cause of uncorrected visual impairment (less than 20/30).
- •Participants with severe color-blindness.
- •Participants with developmental cognitive dysfunction (congenital, pediatric).
- •Major psychiatric disorder (e.g., chronic psychosis, recurrent depressive disorder, generalized anxiety disorder).
- •Use of cognitive enhancing drugs (e.g., cholinesterase inhibitors).
- •A concurrent diagnosis of epilepsy.
- •History of alcohol misuse and/or illicit drug use.
- •History of acute damage, including stroke, traumatic brain injury, tumors, etc.
- •Presence of sleep apnea.
- •Recent participation in another neuropsychological study.
结局指标
主要结局
Accuracy of ViewMind Atlas™ in Identifying Cognitive Impairment
时间窗: At baseline (Visit 1)
Evaluate the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), accuracy, and likelihood ratios (positive and negative) of ViewMind Atlas™ compared to clinical diagnosis rendered by qualified providers using standard neuropsychological assessments.
次要结局
未报告次要终点