Comparing digital cognitive assessment and blood biomarkers of dementia in older adults

Not Applicable

Completed

• Conditions: Mild Alzheimer’s disease (mild AD), mild cognitive impairment (MCI); Nervous System Diseases; Alzheimer disease

• Registration Number: ISRCTN18112405
• Lead Sponsor: Cognetivity Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-08-17
• Study Completion: 2021-02-01
• Last Update Posted: 4 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Capacity to understand the information about the study and to give consent to participate
2. Males and females aged between 50-90 years
3. Not currently on medication that may interfere with the study results
4. Healthy individuals; or individuals with specialist diagnosis of mild cognitive impairment or mild AD according to NINCDS-ADRDA criteria

Exclusion Criteria

1. Presence of significant cerebrovascular disease
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, generalized anxiety disorder
4. The use of cognitive-enhancing drugs e.g. cholinesterase inhibitors, unless on stable doses
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 TBI
10. Presence of sleep apnoea

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Serum amyloid-beta 40 and amyloid-beta 42 levels measured using ELISA test at baseline<br> 2. Serum Phosphorylated Tau level measured using ELISA test at baseline<br> 3. Serum Neurofilament light-chain (NFL) levels measured using ELISA test at baseline<br> 4. Level of cognitive performance measured by ICA test at baseline<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. APOE genotype determined by DNA sequencing at baseline<br> 2. Level of cognitive performance measured by MoCA test at baseline<br>