ISRCTN95636074已完成未知
A validation study of a computerised, artificial intelligence assisted cognitive assessment test compared to a widely used cognitive assessment test and specialist clinical diagnosis in patients with Alzheimer’s dementia and mild cognitive impairment
Cognetivity Limited0 个研究点目标入组 414 人开始时间: 2018年3月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 414
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Current inclusion criteria as of 05/03/2019:
- •Inclusion criteria for the control group:
- •1. Addenbrooke’s Cognitive Assessment (ACE-III) score of >= 90/100
- •2. Bristol Activities of Daily Living Scale score of unimpaired” or mildly impaired”
- •3. Capacity to understand the information about the study and to give consent to
- •participate
- •4. Males and females aged between 55-90 years.
- •5. Not currently on medication that may interfere with the study results.
- •6. In good general health.
- •Inclusion criteria for MCI group:
- •1. A clinical diagnosis of MCI according to NINCDS-ADRDA criteria
- •2. Males and Females aged 55-90 years.
- •3. Willing and able to provide informed consent.
- •Inclusion criteria for AD group:
- •1. A clinical diagnosis of Mild-AD according to NINCDS-ADRDA criteria
- •2. Males and females aged 55-90 years.
- •3. Willing and able to provide informed consent
- •Previous inclusion criteria:
- •Inclusion criteria for the control group:
- •1. Addenbrooke’s Cognitive Assessment (ACE-III) score of >= 90/100
- •2. Bristol Activities of Daily Living Scale score of unimpaired” or mildly impaired”
- •3. Capacity to understand the information about the study and to give consent to participate
- •4. Males and females aged between 55-80 years
- •5. Not currently on medication that may interfere with the study results
- •6. In good general health
- •7. Matched for age and education
- •Inclusion criteria for MCI group:
- •1. A clinical diagnosis of MCI according to NINCDS-ADRDA criteria
- •2. Addenbrooke's Cognitive Assessment (ACE-III) score >= 82
- •3. Males and Females aged 55-80 years
- •4. Willing and able to provide informed consent
- •Inclusion criteria for AD group:
- •1. A clinical diagnosis of Mild-AD according to NINCDS-ADRDA criteria
- •2. Addenbrooke's Cognitive Assessment (ACE-III) score of >= 66/100 and <= 88/100
- •3. Males and females aged 55-80 years
- •4. Willing and able to provide informed consent
排除标准
- •Current exclusion criteria as of 05/03/2019:
- •Exclusion criteria for the control group:
- •1. Presence of significant cerebrovascular disease i.e. history of CVA
- •2. Major medical co-morbidities e.g. congestive cardiac failure, diabetes mellitus with renal impairment
- •3. Major psychiatric disorder e.g. chronic psychosis, recurrent depressive disorder, generalised anxiety disorder.
- •4. The use of cognitive enhancing drugs e.g. cholinesterase inhibitors
- •5. A concurrent diagnosis of epilepsy
- •6. A history of alcohol dependence
- •7. A history of illicit drug use
- •8. A history of severe visual impairment, e.g. macular degeneration, diabetic retinopathy, as determined by the clinical team
- •9. A history of head trauma
- •10. Severe upper limb arthropathy
- •Exclusion criteria for MCI group:
- •1. Patients who fulfill criteria for a diagnosis of Mild AD
- •2. Major medical co-morbidities e.g. congestive cardiac failure, diabetes mellitus with renal impairment
- •3. Major psychiatric disorder e.g. chronic psychosis, recurrent depressive disorder, generalised anxiety disorder.
- •4. The use of cognitive enhancing drugs e.g. cholinesterase inhibitors
- •5. A concurrent diagnosis of epilepsy
- •6. A history of alcohol misuse
- •7. A history of illicit drug use
- •8. A history of severe visual impairment, e.g. macular degeneration, diabetic retinopathy, as determined by the clinical team
- •9. A history of head trauma
- •10. Presence of sleep apnoea
- •11. Severe upper limb arthropathy
- •Exclusion criteria for AD group:
- •1. Patients who fulfill criteria for a diagnosis of moderate AD or other types of dementia
- •2. Major medical comorbidities e.g. congestive cardiac failure, diabetes mellitus with renal impairment
- •3. Major psychiatric disorder eg. chronic psychosis, recurrent depressive disorder, generalised anxiety disorder.
- •4. A concurrent diagnosis of epilepsy
- •5. A history of alcohol misuse
- •6. A history of illicit drug use
- •7. A history of severe visual impairment, e.g. macular degeneration, diabetic retinopathy, as determined by the clinical team
- •8. A history of head trauma
- •9. Presence of sleep apnoea
- •10. Severe upper limb arthropathy
- •Previous exclusion criteria:
- •Exclusion criteria for the control group:
- •1. Presence of significant cerebrovascular disease i.e. history of CVA
- •2. Major medical co-morbidities e.g. congestive cardiac failure, diabetes mellitus with renal impairment
- •3. Major psychiatric disorder eg. chronic psychosis, recurrent depressive disorder, generalised anxiety disorder
- •4. The use of cognitive enhancing drugs e.g. cholinesterase inhibitors
- •5. A concurrent diagnosis of epilepsy
- •6. A history of alcohol dependence
- •7. A history of illicit drug use
- •8. A history of severe visual impairment, e.g. macular degeneration, diabetic retinopathy, as determined by the clinical team
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