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

Association between the Integrated Cognitive Assessment (ICA) and fluid biomarkers of neurodegeneration

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN18112405
Enrollment
60
Registered
2020-08-17
Start date
2020-08-20
Completion date
Unknown
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Participants undergo a cognitive assessment using both the ICA and the Montreal cognitive assessment (MoCA) at baseline. A blood sample will also be taken to measure the level of amyloid-beta, p-Tau,

Sponsors

Cognetivity Ltd
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
1. APOE genotype determined by DNA sequencing at baseline 2. Level of cognitive performance measured by MoCA test at baseline

Countries

Iran

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026