跳至主要内容
临床试验/NCT03900936
NCT03900936Unknown不适用

Detecting Dementia Earlier: Using Spatial & Episodic Memory Tests to More Accurately Predict Progression From Mild Cognitive Impairment to Alzheimer's Disease

South Tees Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年1月19日最近更新:
适应症

试验速览

阶段
不适用
入组人数
20
试验地点
1
主要终点
Predicting progression

研究概览

简要总结

Aims

  1. To determine whether the 4 Mountains test of allocentric (i.e. viewpoint-independent) spatial memory, and tests of memory for a recent experience (e.g. watching a brief video), to diagnose the early stages of Alzheimer's disease.
  2. We operationalise this as the ability of these tests to predict whether or not an individual progresses from having some cognitive difficulties (diagnosed as 'mild cognitive impairment' MCI) to subsequently developing Alzheimer's disease up to two years later.
  3. To assess whether the ability to diagnose early stages of Alzheimer's disease can be improved by combining the scores from different memory tests, from questionnaires assessing spatial and social aspects of everyday life.
  4. To assess whether scores on the spatial memory test are correlated with patients' reports of their everyday spatial memory, using a newly-developed questionnaire.

Outcome Measures

Primary study objective:

To determine the ability of allocentric spatial and episodic memory test performance to predict progression from mild cognitive impairment (MCI) to Alzheimer's disease.

Secondary outcome measure

  1. To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease.
  2. To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.

详细描述

In recent years, the need for tests that reliably diagnose the early stages of Alzheimer's disease (AD) with high accuracy has been strongly emphasised. Detecting AD in its earliest stages increases the likelihood that therapeutic agents (e.g. newly-developed drugs) and interventions (e.g. changes in diet and exercise) can prolong the period of high-quality, independent living and reduce the impact on patients, families and care providers. An ideal test would have the sensitivity to detect everyone who has early-stage AD, while simultaneously not giving a 'false alarm' to anyone who shows some age-related impairments in cognition but who does not have early-stage AD. Secondly, an ideal test should be free and simple to administer on a national scale, without requiring extensive training on the part of the testers to set up, run, and interpret. Unfortunately, currently used tests do not come close to this ideal. There are some good biomarker-based tests for early stages of AD, but they are costly, highly invasive and in effect impossible to use for national screening purposes. MRI imaging of brain regions affected early in AD detects early AD no better than neuropsychological testing and whilst it is non-invasive, many patients find it aversive. Here, we propose to examine whether the use of spatial and episodic memory tests can get us nearer to this ideal, whether used singly, together, or in combination with other tests.

The project has two stages. In stage 1, we will administer recently-developed spatial and episodic memory tests (along with more established neuropsychological tests) to patients who have recently been diagnosed with Mild Cognitive Impairment (MCI). At stage 2, clinical follow up (c.15-30 months after MCI diagnosis) we will establish those patients who have, and have not, progressed to AD. Analysis will then determine which tests at stage 1 best predicted progression-to-AD at stage 2.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • . MCI diagnosis.

排除标准

  • Presence of significant neurological condition such as Traumatic Brain Injury, Epilepsy, Stroke, Multiple Sclerosis, Brain tumour, Encephalitis, Meningitis, Parkinson's disease or visual impairment severe enough to hamper processing of visual test stimuli.
  • Major psychiatric disorder, such as schizophrenia, bipolar disorder and personality disorders such as borderline personality disorder. We will exclude severe (but not mild or moderate) clinical depression, and will exclude severe (but not mild or moderate) anxiety.
  • The use of cognitive enhancing drugs e.g. Cholinesterase inhibitors.
  • A history of alcohol excess or excess of illicit drug use within the last 5 years.
  • (By definition, the diagnosis of dementia excludes a participant, since this would conflict with the fourth basis for the MCI diagnosis)

结局指标

主要结局

Predicting progression

时间窗: 3 years

To determine the ability of allocentric spatial and episodic memory test performance to predict progression from mild cognitive impairment (MCI) to Alzheimer's disease.

Social Characteristics and questionnaires

时间窗: 3 years

1. To assess to what extent social characteristics of everyday life may impact upon progression from mild cognitive impairment (MCI) to Alzheimer's disease. 2. To correlate allocentric spatial test performance with real-world spatial ability as assessed through a novel spatial questionnaire.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Detecting Dementia Earlier | 临床试验