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

Primary Purpose

Dementia Alzheimers

Status
Not yet recruiting
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
G:DATA, dementia screen videogame
Sponsored by
Ascentys Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Dementia Alzheimers

Eligibility Criteria

55 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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-

Sites / Locations

  • Hywel Dda University Health Board

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Early AD

MCI

Health Control

Arm Description

10 participants with early AD Intervention: Game

10 participants with mild cognitive impairment Intervention: Game

10 healthy control participants Intervention: Game

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 2, 2023
Last Updated
September 19, 2023
Sponsor
Ascentys Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT06047340
Brief Title
Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Acronym
G:DATA
Official Title
Feasibility Study for the Use of Computer Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ascentys Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia Alzheimers

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Interventional study with three study arms (mild cognitive impairment, mild AD-related dementia, healthy controls).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early AD
Arm Type
Experimental
Arm Description
10 participants with early AD Intervention: Game
Arm Title
MCI
Arm Type
Experimental
Arm Description
10 participants with mild cognitive impairment Intervention: Game
Arm Title
Health Control
Arm Type
Active Comparator
Arm Description
10 healthy control participants Intervention: Game
Intervention Type
Device
Intervention Name(s)
G:DATA, dementia screen videogame
Intervention Description
A videogame for screening
Primary Outcome Measure Information:
Title
In Game Navigation Test Score
Description
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.
Time Frame
9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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-
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sayed Kazmi
Phone
07989923086
Email
sayedkazmi@hotmail.com
Facility Information:
Facility Name
Hywel Dda University Health Board
City
Carmarthen
State/Province
Wales
ZIP/Postal Code
SA31 3BB
Country
United Kingdom
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Rees
Email
sarah.rees7@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
Simon Gerhand

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
http://www.ascentys.co.uk

Learn more about this trial

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

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