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

NCT ID: NCT06047340

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-02

Study Completion Date

2023-12-31

Brief Summary

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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

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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.

Conditions

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Dementia Alzheimers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Interventional study with three study arms (mild cognitive impairment, mild AD-related dementia, healthy controls).
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Early AD

10 participants with early AD

Intervention: Game

Group Type EXPERIMENTAL

G:DATA, dementia screen videogame

Intervention Type DEVICE

A videogame for screening

MCI

10 participants with mild cognitive impairment

Intervention: Game

Group Type EXPERIMENTAL

G:DATA, dementia screen videogame

Intervention Type DEVICE

A videogame for screening

Health Control

10 healthy control participants

Intervention: Game

Group Type ACTIVE_COMPARATOR

G:DATA, dementia screen videogame

Intervention Type DEVICE

A videogame for screening

Interventions

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G:DATA, dementia screen videogame

A videogame for screening

Intervention Type DEVICE

Eligibility Criteria

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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-
Minimum Eligible Age

55 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ascentys Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hywel Dda University Health Board

Carmarthen, Wales, United Kingdom

Site Status

Countries

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United Kingdom

Central Contacts

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Sayed Kazmi

Role: CONTACT

07989923086

Facility Contacts

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Sarah Rees

Role: primary

Other Identifiers

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321523

Identifier Type: -

Identifier Source: org_study_id

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