Clinical trial NCT06047340: Feasibility Study of Game Technology in the Early Diagnosis of Mild Cognitive Impairment and Alzheimer's Disease
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
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dementia Alzheimers
Lead sponsor: Ascentys Ltd
Sponsor class: INDUSTRY
First posted: 2023-09-21
Enrollment: 30
Sex: ALL
Minimum age (years): 55
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Interventional study with three study arms (mild cognitive impairment, mild AD-related dementia, healthy controls).
Primary purpose: SCREENING

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.

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-

Primary outcomes:
measure: In Game Navigation Test Score
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Carmarthen
country: United Kingdom
facility: Hywel Dda University Health Board
state: Wales
Study officials:
References: