Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease (G:DATA)

• ClinicalTrials.gov Identifier: NCT06047340
• Recruitment Status: Not yet recruiting
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Sponsor: Ascentys Ltd
• Information provided by (Responsible Party): Ascentys Ltd

Study Description

Brief 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. The Investigators will also ask patients and healthcare staff for participant views on the G:DATA game.

Condition or disease	Intervention/treatment	Phase
Dementia Alzheimers	Device: G:DATA, dementia screen videogame	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Interventional study with three study arms (mild cognitive impairment, mild AD-related dementia, healthy controls).
• Masking: None (Open Label)
• Primary Purpose: Screening
• Official Title: Feasibility Study for the Use of Computer Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
• Estimated Study Start Date: October 2, 2023
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: December 31, 2023

Arms and Interventions

Arm	Intervention/treatment
Experimental: Early AD; 10 participants with early AD Intervention: Game	Device: G:DATA, dementia screen videogame; A videogame for screening
Experimental: MCI; 10 participants with mild cognitive impairment Intervention: Game	Device: G:DATA, dementia screen videogame; A videogame for screening
Active Comparator: Health Control; 10 healthy control participants Intervention: Game	Device: G:DATA, dementia screen videogame; A videogame for screening

Outcome Measures

Primary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 79 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

Inclusion Criteria:

• Aged between 55-79 years
• Willing and able to provide informed consen-

Exclusion Criteria:

• 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-

Contacts and Locations

Contacts

Contact: Sayed Kazmi; 07989923086; sayedkazmi@hotmail.com

Locations

United Kingdom

Hywel Dda University Health Board

Carmarthen, Wales, United Kingdom, SA31 3BB

Contact: Sarah Rees sarah.rees7@wales.nhs.uk

Principal Investigator: Simon Gerhand

Sponsors and Collaborators

Ascentys Ltd

More Information

• Responsible Party: Ascentys Ltd
• ClinicalTrials.gov Identifier: NCT06047340
• Other Study ID Numbers: 321523
• First Posted: September 21, 2023
• Last Update Posted: September 21, 2023
• Last Verified: September 2023

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: 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.
• Supporting Materials: Study Protocol

Time Frame

start date 01/09/23 end date 31/12/23

I couldn't select the no ipd sharing option

• Access Criteria: no one beyond the study team will be able to access data I couldn't select the no ipd sharing option
• URL: http://www.ascentys.co.uk

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Alzheimer Disease; Cognitive Dysfunction; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders