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

Study Overview
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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.

Official Title
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Feasibility Study for the Use of Computer Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease

Conditions
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Dementia Alzheimers

Intervention / Treatment
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* Device: G:DATA, dementia screen videogame


Participation Criteria
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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-

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Interventional study with three study arms (mild cognitive impairment, mild AD-related dementia, healthy controls).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early AD<br>10 participants with early AD Intervention: Game | Device: G:DATA, dementia screen videogame<br>* A videogame for screening<br>|
| Experimental: MCI<br>10 participants with mild cognitive impairment Intervention: Game | Device: G:DATA, dementia screen videogame<br>* A videogame for screening<br>|
| Active Comparator: Health Control<br>10 healthy control participants Intervention: Game | Device: G:DATA, dementia screen videogame<br>* A videogame for screening<br>|

What is the study measuring?
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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 |