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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dementia Alzheimers
• Intervention / Treatment: Device: G:DATA, dementia screen videogame

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 Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sayed Kazmi; Phone Number: 07989923086; Email: sayedkazmi@hotmail.com

Study Locations

• United Kingdom
  • Wales
    • Carmarthen, Wales, United Kingdom, SA31 3BB
      • Hywel Dda University Health Board
      • Contact: Sarah Rees; Email: sarah.rees7@wales.nhs.uk
      • Principal Investigator: Simon Gerhand

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	9 months

Collaborators and Investigators

• Sponsor: Ascentys Ltd

Study record dates

Study Major Dates

• Study Start (Estimated): October 2, 2023
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: September 2, 2023
• First Submitted That Met QC Criteria: September 19, 2023
• First Posted (Actual): September 21, 2023

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 19, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 321523

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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.

IPD Sharing Time Frame

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

I couldn't select the no ipd sharing option

• IPD Sharing Access Criteria: no one beyond the study team will be able to access data I couldn't select the no ipd sharing option
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No