A validation study of the Integrated Cognitive Assessment (ICA)

Not Applicable

Completed

• Conditions: Mild Alzheimer's dementia, mild cognitive impairment; Mental and Behavioural Disorders; Dementia in Alzheimer disease

• Registration Number: ISRCTN95636074
• Lead Sponsor: Cognetivity Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-03-26
• Study Completion: 2021-08-31
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 414

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Cognitive impairment is measured using the Integrated Cognitive Assessment (ICA) at 2 and 4 weeks<br> 2. Cognitive impairment is measured using the Montreal Cognitive Assessment (MoCA) at 2 and 4 weeks<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Cognitive impairment is measured using the Addenbrooke's Cognitive Assessment- III (ACE-III) questionnaire at Assessment Visit<br> 2. Functional impairment is measured using the Bristol Activities of Daily Living Scale (BADLS) questionnaire at Assessment Visit<br> 3. Mood disorder is measured using the Hospital Anxiety and Depression Scale (HADS) questionnaire at Assessment Visit<br><br> 05/03/2019: timepoint changed from baseline to Assessment Visit.<br>