跳至主要内容
临床试验/NCT04889560
NCT04889560Unknown不适用

Home-based Cognitive Treatment of Early Stages of Cognitive Impairment in Neurodegenerative Diseases: Home CoRe

IRCCS National Neurological Institute "C. Mondino" Foundation2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年6月30日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Mini-Mental State Examination (MMSE)

研究概览

简要总结

The prevalence of neurodegenerative diseases is expected to increase over the next years, in parallel with the aging of the world population. Therefore, it is important to identify new methods to prevent, delay or stop the neurodegenerative waterfall responsible for dementia conversion. To date, there is no fully proven pharmacological treatment for cognitive impairment and the available pharmacological treatments have limited efficacy because consist in symptomatic drugs with adverse side effects. On this point, non-pharmacological intervention may represent adjunctive therapy to medications in order to prevent or delay the onset of the cognitive deficits or dementia. Recently we evaluated the effectiveness of a computerized cognitive training (CoRe) in patients with early cognitive impairment. The main goal of the present protocol is to evaluate the efficacy of the home-based version of CoRe (Home CoRe). To this end, mild dementia or early cognitive impairment, and persons with Subjective Cognitive Impairment (SCI) are enrolled and randomly assigned to the experimental group (Home CoRe) or control group (CoRe). All patients are evaluated before (T0) and after (T1) treatment with an exhaustive neuropsychological assessment. Furthermore, follow-up visits are scheduled 6 months (T2) and 12 months (T3) after the end of the treatment.

详细描述

Non-pharmacological intervention may represent adjunctive therapy to medications in order to delay the onset of the cognitive deficits or dementia. Moreover, increasing evidence suggests that environmental and lifestyle factors (education, cognitive engagement, experience..) impact on cognitive functions and brain plasticity during the lifetime and also during aging. These modifiable factors moderate differences in cognitive aging and are protective for the development of dementia.

Among non-pharmacological approaches, previous studies observed a positive effect of Cognitive Training (CT) both in healthy elderly people and patients in the early stage of neurodegenerative diseases. Moreover, the advances in the development of Information & Communication Technologies (ICT) has prompted the possibility to develop computer-based solution for the training of cognitive functions, being able to overcome traditional-training advantages. However, some issue remain unresolved and larger randomized controlled trials are necessary to examine long-term CT effects, due to the lack of longitudinal studies. Our previous data demonstrated that CT program with CoRe software is safe and effective on cognition in patient with Parkinson Disease-Mild Cognitive Impairment, in the attempt of briefly stabilizing cognitive decline, delaying the downward trajectory. The same pattern of findings resulted when using CoRe in patients with Mild Cognitive Impairment (MCI) and mild Alzheimer's Disease (AD). Among ICT advantages there is the fact that they offer the possibility to develop patient tailored interventions that can be easily delivered not only in-person but also remotely at patients' homes. It means that they could simplify the therapist's work in terms of the planning, design, and management of the cognitive intervention also outside from the clinical setting. However, some concerns have slowed the integration of home-based interventions into clinical practice, such as the fact that people with advanced age or cognitive deficit might have poor computer skills and difficulties managing technological devices on their own. Thus, the overall efficacy of home-based CT programs is still under debate.

In this frame, the primary goal of this single-blind randomized controlled trial is to assess whether a home-based CT (Home CoRe) could offer comparable effects (non-inferiority trial) to those of an in-person CT (CoRe). A secondary goal is to follow these effects with respect to the evolution of cognitive decline. These two interventions are evaluated also in terms of treatment adherence.

Both treatment protocols consist of 18 sessions (3 session/week, 45 minutes/day) of CT with CoRe vs HomeCoRe software (training memory and logical-executive functions).

Patients with mild dementia, early cognitive impairment (i.e., MCI and vascular cognitive impairment (VCI)), and SCI are recruited from Neuropsychology/Alzheimer's Disease Assessment Unit and Neurorehabilitation Unit of IRCCS Mondino Foundation. Patients' diagnosis is formulated on the basis of a comprehensive neuropsychological evaluation (baseline cognitive assessment - T0) according to the guidelines presented in the literature. The following standardized tests assessing different domains are used:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Single (neuropsychologist for cognitive assessments)

入排标准

年龄范围
50 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • presence of mild dementia, mild cognitive impairment; vascular cognitive impairment, subjective cognitive impairment;
  • age between 50 and 85 years;
  • educational level ≥ 5 years.

排除标准

  • MMSE < 20
  • pre-existing cognitive impairment (e.g. aphasia, neglect);
  • severe disturbances in consciousness;
  • concomitant severe psychiatric disease or others neurological conditions (e.g. depression and behavioral disorders).

结局指标

主要结局

Mini-Mental State Examination (MMSE)

时间窗: Change from T0 to T1, T2 and T3

Global cognitive functioning measured by MMSE. MMSE is a neuropsychological test for the evaluation of intellectual efficiency disorders and the presence of cognitive impairment. The total score is between a minimum of 0 and a maximum of 30 points. A score of 18 or less indicates a severe impairment of cognitive abilities a score between 18 and 24 indicates moderate to mild impairment, a score of 25 is considered borderline, and a score of 26 to 30 indicates cognitive normality.

Montreal Overall Cognitive Assessment (MoCA)

时间窗: Change from T0 to T1, T2 and T3

Global cognitive functioning measured by MoCA. MoCA is a widely used screening assessment for detecting cognitive impairment. The MoCA test is a 30-point test. Lower score is worst outcome.

次要结局

  • Patients Reported Outcome Measures (PROMS)(Change from T0 to T1)
  • Beck Depression Inventory - BDI(Change from T0 to T1, T2 and T3)
  • Number of CT sessions completed(Change from T0 to T1, T2 and T3)
  • Short Form-36 Health Survey - SF-36(Change from T0 to T1, T2 and T3)
  • Patient Global Impression of Change - PGIC(Change from T0 to T1)
  • Clinical Dementia Rating Scale (CDR)(Change from T0 to T1, T2 and T3)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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