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

Sponsor
Ascentys Ltd (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06047340
Collaborator
(none)
30
1
3
3
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Study Details

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
  • Device: G:DATA, dementia screen videogame
N/A

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
Anticipated 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).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
Anticipated Study Start Date :
Oct 2, 2023
Anticipated Primary Completion Date :
Dec 31, 2023
Anticipated Study Completion Date :
Dec 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 [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

Criteria

Ages Eligible for Study:
55 Years to 79 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Hywel Dda University Health Board Carmarthen Wales United Kingdom SA31 3BB

Sponsors and Collaborators

  • Ascentys Ltd

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ascentys Ltd
ClinicalTrials.gov Identifier:
NCT06047340
Other Study ID Numbers:
  • 321523
First Posted:
Sep 21, 2023
Last Update Posted:
Sep 21, 2023
Last Verified:
Sep 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 21, 2023