Dementia AlzheimersG:DATANCT06047340
Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
A study testing G:DATA, dementia screen videogame in people with Dementia Alzheimers, run by Ascentys Ltd at 1 site in United Kingdom.
Trial summary
This study will test G:DATA, a simple computer game designed to diagnose Alzheimer's Disease, in three different groups of people, some of whom have Alzheimer's Disease. It will look at whether the results of G:DATA match the results of tests that are used to diagnose people with Alzheimer's Disease now. Read more about this study
- Who is it for?
- Ages 55 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Dementia Alzheimers
- What is being tested?
- G:DATA, dementia screen videogame
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Oct 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged between 55-79 years
- Willing and able to provide informed consen-
Who cannot join
- A concurrent diagnosis of epilepsy
- A history of severe visual impairment, e.g. macular degeneration, diabetic reti-nopathy, as determined by the clinical team
- A history of head trauma
- Presence of Sleep Apnoea
- History of alcohol dependence
- History of illicit drug use
- Severe upper limb arthropathy
- The use of cognitive enhancing drugs e.g. cholinesterase inhibitors-
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hywel Dda University Health Board
Carmarthen, Wales, SA31 3BB
Sarah Rees, sarah.rees7@wales.nhs.uk
Simon Gerhand
About this study
Official title: Feasibility Study for the Use of Computer Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
This study will test G:DATA, a simple computer game designed to diagnose Alzheimer's Disease, in three different groups of people, some of whom have Alzheimer's Disease. It will look at whether the results of G:DATA match the results of tests that are used to diagnose people with Alzheimer's Disease now. The Investigators will also ask patients and healthcare staff for participant views on the G:DATA game.
Read the detailed description
Alzheimer's Disease is a type of dementia that causes progressive deterioration to memory, thinking and behaviour. It is currently thought to affect 50 million people globally, although 75% of those affected are thought to be undiagnosed, with no access to treatment.[2] Diagnosis requires extensive clinical evaluation, involving a range of techniques that are resource-intensive and can only be performed in clinical settings. Research has demonstrated a direct link between carefully designed spatial learning within computer games and the detection of deterioration in specific brain cells first affected by Alzheimer's Disease, overlooked by existing assessment techniques. This research will look at the feasibility of using a computer game diagnostic tool, called G:DATA, in the diagnosis of Alzheimer's Disease. It will do this by providing a clinical benchmark, consolidating the results of gameplay performance against current clinical gold-standard assessments, during a clinical study conducted with two patient groups (patients with Mild Cognitive Impairment (MCI), patients with mild AD-related dementia) and a healthy controls group. Outcomes will include validity data of the game's output in diagnosing Alzheimer's Disease, together with data on the tool's usability, and acceptability.
- Conditions
- Dementia Alzheimers
- Being tested
- G:DATA, dementia screen videogame
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
G:DATA, dementia screen videogameDevice
A videogame for screening
| Study group | Role | What they receive |
|---|---|---|
| Early AD | Experimental | 10 participants with early AD
Intervention: Game Receives: Device: G:DATA, dementia screen videogame |
| MCI | Experimental | 10 participants with mild cognitive impairment
Intervention: Game Receives: Device: G:DATA, dementia screen videogame |
| Health Control | Active comparator | 10 healthy control participants
Intervention: Game Receives: Device: G:DATA, dementia screen videogame |
What is being measured
The primary outcome is the main question the study is designed to answer.
In Game Navigation Test Score
In Game Navigational Test Score of each participant in correlation to clinical assessment score. This doesn't use any form of scale and higher scores refer to worse outcome.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2023
- Study start2 Oct 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dementia AlzheimersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Interventional study with three study arms (mild cognitive impairment, mild AD-related dementia, healthy controls).
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentys Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06047340
- Sponsor's protocol ID
- 321523
- Acronym
- G:DATA
- Status last verified
- Sep 2023
- First submitted
- 2 Sep 2023
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Participants will be assigned a unique study ID and data collected will be labelled with the study ID only. An enrolment log will record participant name, date of birth and hospital or NHS number. No personal identifiable information will be included as part of the research dataset leaving the local site for analysis.
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study for the Use of Computer Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06047340
- Acronym / sponsor ID
- G:DATA / 321523
- Conditions
- Dementia Alzheimers
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ascentys LtdIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 21 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test G:DATA, a simple computer game designed to diagnose Alzheimer's Disease, in three different groups of people, some of whom have Alzheimer's Disease. It will look at whether the results of G:DATA match the results of tests that are used to diagnose people with Alzheimer's Disease now. The Investigators will also ask patients and healthcare staff for participant views on the G:DATA game.
Detailed description
Alzheimer's Disease is a type of dementia that causes progressive deterioration to memory, thinking and behaviour. It is currently thought to affect 50 million people globally, although 75% of those affected are thought to be undiagnosed, with no access to treatment.[2] Diagnosis requires extensive clinical evaluation, involving a range of techniques that are resource-intensive and can only be performed in clinical settings. Research has demonstrated a direct link between carefully designed spatial learning within computer games and the detection of deterioration in specific brain cells first affected by Alzheimer's Disease, overlooked by existing assessment techniques. This research will look at the feasibility of using a computer game diagnostic tool, called G:DATA, in the diagnosis of Alzheimer's Disease. It will do this by providing a clinical benchmark, consolidating the results of gameplay performance against current clinical gold-standard assessments, during a clinical study conducted with two patient groups (patients with Mild Cognitive Impairment (MCI), patients with mild AD-related dementia) and a healthy controls group. Outcomes will include validity data of the game's output in diagnosing Alzheimer's Disease, together with data on the tool's usability, and acceptability.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Interventional study with three study arms (mild cognitive impairment, mild AD-related dementia, healthy controls).
| Arm | Type | Receives |
|---|---|---|
| Early AD | Experimental | Device: G:DATA, dementia screen videogame10 participants with early AD Intervention: Game |
| MCI | Experimental | Device: G:DATA, dementia screen videogame10 participants with mild cognitive impairment Intervention: Game |
| Health Control | Active comparator | Device: G:DATA, dementia screen videogame10 healthy control participants Intervention: Game |
Who may qualify
- Ages
- 55 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged between 55-79 years
- Willing and able to provide informed consen-
Key exclusion criteria (8 listed)
- A concurrent diagnosis of epilepsy
- A history of severe visual impairment, e.g. macular degeneration, diabetic reti-nopathy, as determined by the clinical team
- A history of head trauma
- Presence of Sleep Apnoea
- History of alcohol dependence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| G:DATA, dementia screen videogameA videogame for screening | Device | Early AD, Health Control, MCI |
Primary outcome
In Game Navigation Test Score
Time frame: 9 months
In Game Navigational Test Score of each participant in correlation to clinical assessment score. This doesn't use any form of scale and higher scores refer to worse outcome.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Individual participant dataSharing planned: Yes. Participants will be assigned a unique study ID and data collected will be labelled with the study ID only. An enrolment log will record participant name, date of birth and hospital or NHS number. No personal identifiable information will be included as part of the research dataset leaving the local site for analysis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing G:DATA, dementia screen videogame in people with Dementia Alzheimers, run by Ascentys Ltd at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sayed Kazmi (07989923086, sayedkazmi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In Game Navigation Test Score (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.