Condition category
Nervous System Diseases
Date applied
11/08/2020
Date assigned
17/08/2020
Last edited
17/08/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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)
Seyed@Cognetivity.com
2. Dr Zahra Vahabi (neurologist)
zvahabi@sina.tums.ac.ir
3. Chris Kalafatis (old age psychiatrist)
chris@cognetivity.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Seyed-Mahdi Khaligh-Razavi

ORCID ID

https://orcid.org/0000-0002-5700-1704

Contact details

Cognetivity Ltd
3 Waterhouse Sq
138 Holborn
London
EC1N 2SW
United Kingdom
+44 (0)2030023628
Seyed@Cognetivity.com

Type

Scientific

Additional contact

Dr Zahra Vahabi

ORCID ID

Contact details

Tehran University of Medical Sciences
Tehran
1417653911
Iran
+98 (0)21 8889 6692
zvahabi@sina.tums.ac.ir

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CGN-2003

Study information

Scientific title

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

Acronym

Study hypothesis

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.

Ethics approval

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; ethics@behdasht.gov.ir), ref: IR.TUMS.MEDICINE.REC.1390.290

Study design

Observational case-control study

Primary study design

Observational

Secondary study design

Case-control study

Trial setting

Other

Trial type

Diagnostic

Patient information sheet

Not available in web format, please use the contact details to request a participant information sheet

Condition

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

Intervention

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.

Intervention type

Mixed

Phase

Drug names

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

01/07/2020

Overall trial end date

01/02/2021

Reason abandoned (if study stopped)

Eligibility

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

Participant type

Mixed

Age group

Senior

Gender

Both

Target number of participants

60

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

20/08/2020

Recruitment end date

30/01/2021

Locations

Countries of recruitment

Iran

Trial participating centre

Royan Institute
Banihashem Square Banihashem Street Ressalat Highway
Tehran
19395-4644
Iran

Sponsor information

Organisation

Cognetivity Ltd

Sponsor details

3 Waterhouse Square
138 Holborn
London
EC1N 2SW
United Kingdom
+44 (0)7890696924
Seyed@Cognetivity.com

Sponsor type

Industry

Website

https://www.cognetivity.com/

Funders

Funder type

Industry

Funder name

Cognetivity Ltd

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

01/12/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

17/08/2020: Trial's existence confirmed by Tehran University of Medical Sciences research ethics committee.