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

Dementia Alzheimers Clinical Trial

— 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06047340
• Other study ID #: 321523
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: September 2023
• Source: Ascentys Ltd
• Contact: Sayed Kazmi
• Phone: 07989923086
• Email: sayedkazmi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 79 Years

Eligibility

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-

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Dementia Alzheimers

Intervention

Device:
• G:DATA, dementia screen videogame
A videogame for screening

Locations

Country	Name	City	State
United Kingdom	Hywel Dda University Health Board	Carmarthen	Wales

Sponsors (1)

Lead Sponsor	Collaborator
Ascentys Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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