Mild Alzheimer's dementia, mild cognitive impairment Mental and Behavioural Disorders Dementia in Alzheimer disease
Conditions
Interventions
Current interventions as of 05/03/2019:
The study involves two clinical phases:
In Phase I the trialists aim to train the Artificial Intelligence algorithm that will b
Sponsors
Cognetivity Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Cognitive impairment is measured using the Integrated Cognitive Assessment (ICA) at 2 and 4 weeks 2. Cognitive impairment is measured using the Montreal Cognitive Assessment (MoCA) at 2 and 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cognitive impairment is measured using the Addenbrooke's Cognitive Assessment- III (ACE-III) questionnaire at Assessment Visit 2. Functional impairment is measured using the Bristol Activities of Daily Living Scale (BADLS) questionnaire at Assessment Visit 3. Mood disorder is measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire at Assessment Visit 05/03/2019: timepoint changed from baseline to Assessment Visit. | — |
Countries
England, United Kingdom
Contacts
Public ContactChris Kalafatis
Outcome results
None listed