跳至主要内容
临床试验/NCT05815329
NCT05815329招募中不适用

Validation and Clinical Usability of a New Screening Tool: MASCoD - Multidimensional Assessment of Subjective Cognitive Decline

Istituti Clinici Scientifici Maugeri SpA2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年8月2日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
instrument validation

研究概览

简要总结

Subjective cognitive decline-SCD is a subclinical cognitive impairment subjectively experienced without being detectable from a diagnostic and neuropsychological perspective. It can negatively impact on patient's frailty and quality of life and it may be prodromal to severe cognitive impairment. Currently, only a few screening tools focusing mainly on memory complaints exist.

The aim of this study is to analyze if a new screening tool called MASCoD (Multidimensional Assessment of Subjective Cognitive Decline) can detect and monitor the SCD, predicting the risk of developing severe cognitive decline over time.

Specifically, the investigators have the following aims:

primary objectives:

  1. To assess the construct validity and tune the clinical cutoffs of the new instrument through the correlation of MASCoD scores with neuropsychological evaluation and brain 18F-FDG-PET.
  2. To assess the clinical validity (predictive capability) of the new instrument through a classification model (dependent variable: brain 18F-FDG-PET examination; independent variable: MASCoD; control variables: gender, age and neuropsychological evaluation).

Secondary objective:

To evaluate the suitability of MASCoD as tool for the monitoring of patients over time. Specifically, the investigators want to evaluate if the MASCoD score is able to assess the effects of a cognitive treatment and, in turn, to identify outpatients who most likely will benefit from it.

After the multidimensional evaluation at T0, the participants will be randomly allocated into an experimental group and a wait list control group. Specifically, cognitive training will be offered by means of technological devices (Neurotablet).

At T1, all outpatients (experimental group and wait list control group) will be evaluated through MASCoD and the extensive neuropsychological evaluation for the second time.

详细描述

Subjective cognitive decline (SCD) is a subclinical cognitive impairment, which is complained by the individual without being objectively supported at diagnostic and neuropsychological levels. It can negatively influence outpatient's frailty and quality of life, as well as caregiver's burden. It may be associated with anxious and/or depressive symptoms too. Moreover, it can be prodromal to Mild Cognitive Impairment or dementia. Concerning this issue, to date, imaging biomarkers (e.g. positron emission tomography - brain 18F-FDG-PET), can be considered a promising method to predict the development of different forms of future cognitive decline. However, this examination is very expensive for the healthcare system.

Although the clinical manifestations of SCD can differ along several cognitive domains (e.g. memory problems, mental slowness and concentration difficulties, self-perceived deterioration in usual cognitive performance), as far as the investigators know, there are currently only screening tools to investigate subjective memory complaints.

Rehabilitation can play a pivotal role in this condition and non-pharmacological interventions on SCD, as cognitive training, could maintain on existing cognitive resources and slow the rate of possible increasing cognitive decline. To date, lower-functioning individuals seem to benefit more from cognitive training, in particular concerning working memory and executive functions (i.e. inhibition).

Thus, a screening tool assessing all possible subclinical manifestations of SCD and risk factors is needed to support professionals in making differential diagnosis and to predict the risk of developing severe cognitive impairment over time, proposing a personalized care path. From a clinical and research standpoint, a useful screening tool is expected to be brief for usual clinical assessment and research protocol, as well as administrable by different professionals and in various healthcare settings. Moreover, it should suggest targeted interventions to maximize the psychophysical outcome. The development of such a screening tool would address the current shortage of rapid, economic and validated instruments globally assessing over time cognition affected by this condition.

In light of the above issues, the investigators propose a brief, not expensive, multidimensional screening tool called MASCoD (Multidimensional Assessment of Subjective Cognitive Decline) developed on the basis of literature and the clinical experience provided by an experts' panelist (i.e. psychologists, neuropsychologists, neurologists) employed at the Institute for Research, Hospitalization and Healthcare (IRCCS) - Istituti Clinici Scientifici (ICS) Maugeri - Institute of Montescano and Pavia, Italy. It is composed of a general form for socio-demographic data and the following sections: a) risk factors for SCD; b) memory and executive symptoms; c) anxious/depressive or distressing symptoms. There are four increasing risk levels (i.e. low, medium with emotional complaints, medium without emotional complaints, high risk) of developing a severe cognitive impairment. Two versions of MASCoD have been proposed: one for the first baseline screening and one for the follow up assessments.

研究设计

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

入排标准

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

入选标准

  • reported subjective cognitive decline without any other cognitive or neurological issue,
  • Italian education,
  • adult (> 55 years old),
  • understanding of research aims,
  • signed informed consent,
  • participation on a voluntary and non-payied bases.

排除标准

  • serious clinical conditions (e.g. severe cardiac and respiratory problems, neoplasia)
  • prior diagnosis of psychiatric disorders according to DSM-5,
  • prior diagnosis of cognitive decline,
  • relevant visuo-perceptive or hearing deficits,
  • illiteracy or relapse in illiteracy,
  • refusal to partake in the research.

结局指标

主要结局

instrument validation

时间窗: baseline

To assess the construct and clinical validity, and tune the clinical cutoffs of the new instrument MASCoD

次要结局

  • screening for rehabilitation suitability(immediately after the cognitive training)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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