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Transcranial Direct Current Stimulation for Depression in Alzheimer's Disease Patient - Preliminary Research (ADAPT)

2020年2月24日 更新者：National Center of Neurology and Psychiatry, Japan

Ameliorating Depression in Alzheimer's Disease Patients by Transcranial Direct Current Stimulation (ADAPT) - Preliminary Research

This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups).

研究概览

地位

终止

条件

干预/治疗

详细说明

This project will investigate the safety and efficacy of transcranial direct current stimulation (tDCS) in the treatment of depression among patients with Alzheimer's disease. tDCS causes an excitatory effect on the anode side and suppressing effect on the cathode side through sculp with very week currents (2 mA in this project). The investigators aim to ameliorate depressive symptoms among patient with Alzheimer's disease, by anodal stimulation on left dorsolateral prefrontal cortex and cathodal suppression on right supraorbital area. Active stimulation will be compare to sham condition in 20 patients (10 in each groups) from outpatient clinic in National Center of Neurology and Psychiatry, Japan.

研究类型

介入性

注册 (实际的)

4

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

  • 日本
    • Tokyo
      • Kodaira、Tokyo、日本、187-8551
        • National Center of Neurology and Psychiatry

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

65年 至 90年 (年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria.
  2. Participants who meets criteria of depression in Alzheimers defined by NIMH criteria.
  3. Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit.
  4. Participants who have been on fixed dose (including participants not prescribed) of antidementia drugs (donepezil, rivastigmine, galantamine, and memantine) for at least for weeks on the screening visit.
  5. Ambulatory participants with or without any aiding device
  6. Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
  7. A study partner who can report how the participant is doing is needed.
  8. Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent.

Exclusion Criteria: Following potential participants will be excluded

  1. In case their cognitive deficits are better explained by another disease (e.g., cerebral infarction, Parkinson disease, multiple sclerosis, normotensive hydrocephalus).
  2. In case they have history of epilepsy
  3. In case they need treatment by antipsychotics due to significant psychotic symptoms
  4. In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units.
  5. In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
  6. In case ECT or tDCS is clinically contraindicated
  7. In case they are taking benzodiazepines or antiepileptic drugs on the screening visit
  8. In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR)
  9. In case his/her GDS score is lower than 6 at baseline
  10. In case he/she is unable to agree video recording on evaluation interview

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：三倍

武器和干预

参与者组/臂
干预/治疗
有源比较器：Active stimulation
Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks
设备：经颅直流电刺激
假比较器：Sham stimulation
Duration: 30 minutes Intensity: 2 mA Placement: left dorsolateral prefrontal cortex and right supraorbital area Size of electrodes: 5 cm x 7 cm Frequency: 5 days a week for three weeks
其他：Sham Stimulation

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Attrition rate due to any adverse event
大体时间：three weeks
three weeks

次要结果测量

结果测量
措施说明
大体时间
Rate of adverse events related to tDCS procedure
大体时间：three weeks
three weeks
Geriatric Depression Scale
大体时间：one week, two weeks, three weeks, five weeks (followup)
a subjective scale for depressive symptoms
one week, two weeks, three weeks, five weeks (followup)
Cornell Scale for Depression in Dementia
大体时间：two weeks, three weeks, five weeks (followup)
a objective scale for depressive symptoms
two weeks, three weeks, five weeks (followup)
Neuropsychiatric Inventory
大体时间：three weeks, five weeks (followup)
a objective scale for neuropsychiatric symptoms
three weeks, five weeks (followup)
Zarit Burden Interview
大体时间：three weeks, five weeks (followup)
a subjective scale for caregivers' burden
three weeks, five weeks (followup)
Clinical Global Impression of Improvement
大体时间：one, two, three and five weeks (followup)
Clinician-rated impression of improvement
one, two, three and five weeks (followup)
Starkstein Apathy Scale
大体时间：two, three and five weeks (followup)
a subjective scale for apathy
two, three and five weeks (followup)

其他结果措施

结果测量
措施说明
大体时间
Clinical Dementia Rating
大体时间：baseline
severity of dementia
baseline
Quality of Life - Alzheimer's Disease
大体时间：baseline
a QoL scale
baseline
ADCS-ADL
大体时间：baseline
Alzheimer's Disease Co-operative Study - Activity of Daily Living
baseline

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

National Center of Neurology and Psychiatry, Japan

调查人员

  • 首席研究员：Yuma Yokoi, MD、National Center of Neurology and Psychiatry, Japan

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2014年12月1日

初级完成 (实际的)

2017年12月31日

研究完成 (实际的)

2018年3月15日

研究注册日期

首次提交

2015年1月27日

首先提交符合 QC 标准的

2015年1月27日

首次发布 (估计)

2015年1月30日

研究记录更新

最后更新发布 (实际的)

2020年2月26日

上次提交的符合 QC 标准的更新

2020年2月24日

最后验证

2020年2月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • A2014-086

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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赞助者和合作者

医疗条件

药物干预

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条件

罕见疾病

药物干预

膳食补充剂

赞助者/合作者

地点

3
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