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临床试验/NCT06047340
NCT06047340尚未招募不适用

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

Ascentys Ltd2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月2日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
30
试验地点
2
主要终点
In Game Navigation Test Score

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Screening
盲法
None

入排标准

年龄范围
55 Years 至 79 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged between 55-79 years
  • Willing and able to provide informed consen-

排除标准

  • 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-

结局指标

主要结局

In Game Navigation Test Score

时间窗: 9 months

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.

次要结局

未报告次要终点

研究者

发起方
Ascentys Ltd
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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