Plain English Summary
Background and study aims
Dementia is the loss of cognitive functioning (thinking, remembering, and reasoning) and behavioural abilities. Integrated Cognitive Assessment (ICA) is a computerised cognitive assessment tool based on image recognition and operating on the Apple iPad. The ICA uses artificial intelligence (AI)-based algorithms to distinguish between cognitively healthy and cognitively impaired participants. ICA is distinctive as it does not rely on language or education, does not require specialist clinicians to administer the test, and its duration is short (5-6 minutes). ICA is demonstrated to be free from learning bias (i.e. patients cannot memorise it after repeated use), so it can be used several times in shorter intervals to measure changes in cognition. The overall aim of this study is to assess the correlation of ICA with some of the key blood biomarkers of dementia in older adults.
Who can participate?
Adults aged 50-90 with mild Alzheimer’s dementia, mild cognitive impairment, or healthy volunteers
What does the study involve?
Participants undergo a cognitive assessment using both the ICA and the Montreal cognitive assessment (MoCA). A blood sample will also be taken to measure the level of blood biomarkers (amyloid-beta, p-Tau, and NFL), and APOE genotyping.
What are the possible benefits and risks of participating?
This study has a great potential to present a new approach to improve diagnostic accuracy by combining a digital biomarker with blood-based ones. Through participation in this study, participants will learn more about their cognitive status. The risks of participating in the study are generally low. Side effects from having blood drawn typically are quite minor, and may include bruising or minor swelling at the site of the injection, which can be soothed with an ice pack, and light-headedness or dizziness.
Where is the study run from?
Royan Institute (Tehran, Iran)
When is the study starting and how long is it expected to run for?
July 2020 to February 2021
Who is funding the study?
Cognetivity Ltd (UK)
Who is the main contact?
1. Dr Seyed-Mahdi Khaligh-Razavi (scientific)
2. Dr Zahra Vahabi (neurologist)
3. Chris Kalafatis (old age psychiatrist)
Dr Seyed-Mahdi Khaligh-Razavi
3 Waterhouse Sq
Dr Zahra Vahabi
Tehran University of Medical Sciences
+98 (0)21 8889 6692
Association between the Integrated Cognitive Assessment (ICA) and fluid biomarkers of neurodegeneration
This study aims to explore the relationship between the ICA and blood biomarkers of neurodegeneration in healthy controls, patients with mild Alzheimer's disease and mild cognitive impairment.
Approved 03/08/2020, Tehran University of Medical Sciences research ethics committee (Central Building of Tehran University of Medical Sciences, Qods St., Keshavarz Blvd, Tehran, Iran, +98 (0)21 64053419; email@example.com), ref: IR.TUMS.MEDICINE.REC.1390.290
Observational case-control study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use the contact details to request a participant information sheet
Mild Alzheimer’s disease (mild AD), mild cognitive impairment (MCI)
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, and NFL, and APOE genotyping.
Primary outcome measure
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 outcome measures
1. APOE genotype determined by DNA sequencing at baseline
2. Level of cognitive performance measured by MoCA test at baseline
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant 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
Target number of participants
Participant 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
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Banihashem Square Banihashem Street Ressalat Highway
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Planned publication in a peer-reviewed journal. The protocol is not available online and there are no plans to publish the protocol or the statistical analysis plan.
IPD sharing statement
The current data-sharing plans for the current study are unknown and will be made available at a later date
Intention to publish date
Participant level data
To be made available at a later date
Basic results (scientific)