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【ChiCTR1900027029】Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment

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基本信息

登记号

ChiCTR1900027029

试验状态

尚未开始

药物名称

药物类型

规范名称

首次公示信息日的期

2019-10-29

临床申请受理号

靶点

适应症

depressive symptoms

试验通俗题目

Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment

试验专业题目

Structured frontal lobe based cognitive stimulation to older adults with depressive symptoms but without dementia or mild cognitive impairment

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申请人名称

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联系人邮编

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临床试验信息

试验目的

1. to test whether cognitive stimulation can improve depressive symptoms in older adults who are still cognitively relatively normal; 2. to test whether the improvement in depressive symptoms can be explained by changes in cognitive performance, inflammatory response, and BDNF level

试验分类

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试验类型

随机抽样

试验分期

Ⅱ期

随机化

In the randomization procedure, each participant will be assigned a special code generated by a computer. The statistician of the department will perform all the randomization and will not be involved in enrollment or outcome assessment.

盲法

Open label

试验项目经费来源

Direct Grant for Research 2018/2019

试验范围

目标入组人数

实际入组人数

第一例入组时间

2019-11-01

试验终止时间

2020-12-31

是否属于一致性

入选标准

Community-living Chinese individuals aged 55 to 75 years old with subjective cognitive decline and comorbid depressive symptoms will be recruited through elderly social centres in Hong Kong；

排除标准

non-Chinese ethnicity; living in care homes; having history of stroke, traumatic brain injury, Parkinson’s disease, MCI, or clinical dementia; scoring Hong Kong Chinese version of Montreal Cognitive Assessment (HK-MoCA) ≤25 (i.e. the cutoff score for MCI in young old with high educational level); taking drugs that affect cognition (e.g. benzodiazepines, anti-dementia medication, etc.); having history of bipolar affective disorder, psychosis, or substance abuse; already attending other cognitive or psychological intervention programs; and having significant impairments in vision, hearing or communication；

研究者信息

研究负责人姓名

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试验机构

Faculty of Medicine, Chinese University of Hong Kong

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