Condition category
Nervous System Diseases
Date applied
03/02/2020
Date assigned
09/03/2020
Last edited
09/03/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Dementia is a brain condition, which causes a gradual loss of mental ability, including problems with memory, understanding, judgement, thinking and language. Early identification and diagnosis of Dementia are essential for improved health outcomes and service provision. Primary care is invariably the main point of identification.
At present, GPs clinical judgement is the key driver for instigating full evaluations at memory clinics for conditions such as dementia. Clinical practice is known to be inefficient and variable across GP clinics. Existing cognitive tests used in primary care are crude or time-consuming, and tend to only detect cognitive impairment when the disease has progressed significantly. The more detailed tests used in memory clinics or neuropsychological assessments are expensive and often intrusive for the patient and are therefore not suitable for use as a screening tool.

The Integrated Cognitive Assessment (ICA) is a quick and easy to use test of cognitive performance, using an iPad. Users are shown a series of images in quick succession and for each they are asked to respond ‘yes’ or ‘no’ to whether they contained an image of an animal or not. The accuracy and speed of responses are then assessed using Artificial Intelligence that compares ICA tests previously taken by healthy and cognitively impaired individuals. This enables the ICA to provide an objective indication of cognitive performance and the likelihood of impairment. The ICA is registered with UK regulators as a medical device.

In this study, patients who have been referred to NHS memory clinics will be asked to take the ICA, as well as all of the other standard assessments taken as part of their appointment. The ICA result will not inform the diagnosis of the patient or any other aspect of their care. Once the diagnosis of the patient is known, the ICA result will then be compared against the GP referral and the final diagnosis to determine whether the ICA predicted correctly. From this it will be determined whether the use of the ICA could have prevented the referral of patients who were found to be healthy.

The aim of this study is therefore to build clinical and economic evidence to support the use of the ICA as an inexpensive dementia screening tool in the NHS. The study aims to demonstrate whether the use of ICA can improve the dementia care pathway by streamlining the diagnosis of dementia and improving the efficiency of GP referrals and therefore minimising the need for repeated, costly and time-consuming assessments.

Who can participate?
Patients between the ages of 55-90 who have been referred to a memory clinic within Sussex Partnership NHS Foundation Trust and do not already have a diagnosis of dementia can participate in this study. Please refer to the Inclusion/Exclusion Criteria for further information.

What does the study involve?
Participants will be asked to attend an appointment at a designated memory clinic where they will fill in a number of questionnaires and take a survey delivered using an iPad.

What are the possible benefits and risks of participating?
There are no anticipated direct benefits to participants, however, it is hoped that if the ICA is adopted it may provide significant benefit to others in the future.

Where is the study run from?
Sussex Partnership NHS Foundation Trust (UK)

When is the study starting and how long is it expected to run for?
April 2020 to December 2020

Who is funding the study?
Innovate UK

Who is the main contact?
Benjamin Austin (public)
qms@cognetivity.com
Dr Chris Kalafatis (scientific)
chris@cognetivity.com

Trial website

Contact information

Type

Public

Primary contact

Mr Benjamin Austin

ORCID ID

Contact details

3 Waterhouse Square
138 Holborn
London
EC1N 2SW
United Kingdom
+44 (0)2030023628
qms@cognetivity.com

Type

Scientific

Additional contact

Dr Chris Kalafatis

ORCID ID

http://orcid.org/0000-0002-7171-5391

Contact details

3 Waterhouse Square
138 Holborn
London
EC1N 2SW
United Kingdom
+44 (0)2030023628
chris@cognetivity.com

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

CGN-2001, IRAS 277157

Study information

Scientific title

Real-world evidence study of primary care referrals to NHS memory clinics and the clinical and economic case for the adoption of the Integrated Cognitive Assessment to improve the dementia diagnosis pathway

Acronym

ADePT

Study hypothesis

This study will develop a real-world evidence basis to support the adoption of ICA as an inexpensive screening tool for the detection of cognitive impairment and improving the efficiency of the dementia care pathway.

Ethics approval

Approval pending, North of Scotland Research Ethics Committee (Summerfield House, 2 Eday Road, Aberdeen, AB15 6RE, UK; +44 (0)1224 558458; nosres@nhs.net), ref: 20/NS/0029

Study design

Observational cross sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Other

Trial type

Screening

Patient information sheet

Not available in web format. Please contact adeptstudy@cognetivity.com to request a copy of the Participant Information Sheet

Condition

Alzheimer's Disease, Dementia, Mild Cognitive Impairment

Intervention

Participants enrolled in the study will be required to attend one visit at a designated memory clinic (AV1). Information sheets and consent forms shall typically be sent to participants by post with their appointment letter. They may also be provided to potential participants during ‘Appointment 1’. Diagnostic assessments (i.e. ‘Appointment 2’) typically occur within a period of 8 weeks from the appointment letter being sent. AV1 shall occur on the same day as Appointment 2, or up to 28 days after appointment 2.

The schedule of events for AV1 is as follows:
1. Informed Consent
2. Inclusion/Exclusion
3. Demographics*
4. Medical History*
5. History of previous cognitive and functional assessments:
a. History of ACE-III or MoCA*
b. Previous Cognitive Test Scores from GP (if available)*
c. Functional assessment scale (if used)*
6. ICA
7. Adverse Events
8. Enquiry on stimulants, fatigue, sleep
9. ICA Usability Questionnaire*
10. CGN Cognitive Health Questionnaire**
11. Memory Clinic Diagnosis*
*From medical notes obtained from GP and/or Memory Clinic Assessment
** The CGN Cognitive Health Questionnaire can be completed in person with the informant (study partner) or the participant (if the informant is not available or not willing to participate) or via telephone call with the informant only.

The Integrated Cognitive Assessment (ICA) is a 5-minute computerised cognitive assessment tool based on a rapid categorisation task. The test is software-based, self-administered and independent of language and education. It is designed for use on an Apple iPad. The accuracy and speed of responses are assessed during the test. The test data is then assessed using Artificial Intelligence (AI) to compare ICA tests previously taken by healthy and cognitively impaired individuals. This enables the ICA to provide an objective indication of cognitive performance and potential impairment.

The product has the following Intended Use:
The Integrated Cognitive Assessment (ICA) is an adjunctive tool providing objective measures of cognitive function for the clinical evaluation of cognitive performance in individuals aged 55 to 90 years old.

The ICA is defined as a Software as Medical Device (SaMD) and is registered as a Class I Medical Device under the Medical Device Directive (MDD 93/42/EEC) with the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Intervention type

Other

Phase

Drug names

Primary outcome measure

GP referrals with specialist diagnosis of MCI/Dementia:
1. Unnecessary GP referrals according to clinic diagnosis (GP referred but confirmed healthy/other at clinic)
2. Necessary GP referrals according to clinic diagnosis (GP referred and confirmed Dementia/MCI at clinic)

Comparison of ICA outcome with specialist diagnosis of MCI/Dementia:
3. Unnecessary ICA referrals according to clinic diagnosis (ICA outcome Dementia/MCI but confirmed healthy/other at clinic)
4. Necessary ICA referrals according to clinic diagnosis (ICA outcome Dementia/MCI and confirmed Dementia/MCI at clinic)
5. Number of ICA incorrectly not referred according to clinic diagnosis (ICA outcome healthy but confirmed Dementia/MCI at clinic)

Secondary outcome measures

Comparison of GP referrals with specialist diagnosis of all types of cognitive impairment:
1. Unnecessary GP referrals according to clinic diagnosis (GP referred but confirmed healthy at clinic)
2. Necessary GP referrals according to clinic diagnosis (GP referred and confirmed Dementia/MCI/Other cognitive impairment at clinic)

Comparison of ICA outcome with specialist diagnosis of all types of cognitive impairment:
3. Unnecessary ICA referrals according to clinic diagnosis (ICA outcome Dementia/MCI/Other but confirmed healthy at clinic)
4. Necessary ICA referrals according to clinic diagnosis (ICA outcome Dementia/MCI and Dementia/MCI/Other confirmed at clinic)
5. Number of ICA incorrectly not referred according to clinic diagnosis (ICA outcome healthy but Dementia/MCI/Other confirmed at clinic)

6. Qualitative measures of suitability and usability of the ICA in real world clinical environments (ICA Usability Questionnaire)

Overall trial start date

01/10/2019

Overall trial end date

01/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Patients aged between 55-90 years old at the time of AV1 who are referred to the memory clinic who have the capacity to consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

A minimum of 140 participants

Participant exclusion criteria

1. Upper limb arthropathy or motor dysfunction that limits the use of a tablet computer
2. Visual impairment severe enough to limit the use of a tablet computer. As guidance participants who cannot read the small print in a newspaper (even with corrected vision) should be excluded
3. Patients with a known diagnosis of Dementia
4. Patients already receiving Cholinesterase Inhibitors and/or Memantine

Recruitment start date

01/04/2020

Recruitment end date

01/12/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Sussex Partnership NHS Foundation Trust
Swandean Arundel Road
Worthing
BN13 3EP
United Kingdom

Sponsor information

Organisation

Cognetivity Ltd.

Sponsor details

3 Waterhouse Square
138 Holborn
London
EC1N 2SW
United Kingdom
+44 (0)2030023628
qms@cognetivity.com

Sponsor type

Industry

Website

https://www.cognetivity.com/

Funders

Funder type

Government

Funder name

Innovate UK

Alternative name(s)

Funding Body Type

government organisation

Funding Body Subtype

National government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Upon completion of this study the data will be analysed, tabulated and a final study report prepared. Cognetivity Ltd. intends to disseminate the results of this study in academic journals, posters, conference posters, position papers, and by other relevant means. Data gathered through this study shall also provide inputs to the health economics components of the overall ADePT project.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date

Intention to publish date

31/03/2021

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

11/02/2020: Trial’s existence confirmed by North of Scotland Research Ethics Committee.