Ameliorating Depression in Alzheimer's Disease Patients by Transcranial Direct Current Stimulation (ADAPT) - Preliminary Research
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Attrition rate due to any adverse event
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who meets criteria of probable Alzheimer's disease defined by NINCDS-ADRDA research criteria.
- •Participants who meets criteria of depression in Alzheimers defined by NIMH criteria.
- •Participants who have been on fixed dose (including participants without any prescription) of antidepressants for at least two weeks on the screening visit.
- •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.
- •Ambulatory participants with or without any aiding device
- •Participants who have one caregiver, who must live with the patient at least ten hours a week and must report the patient's behavior.
- •A study partner who can report how the participant is doing is needed.
- •Eligible family member must sign and give consent on behalf of participants, whereas participants can give assent.
排除标准
- •Following potential participants will be excluded
- •In case their cognitive deficits are better explained by another disease (e.g., cerebral infarction, Parkinson disease, multiple sclerosis, normotensive hydrocephalus).
- •In case they have history of epilepsy
- •In case they need treatment by antipsychotics due to significant psychotic symptoms
- •In case they have urgent risk of suicide or severe depression and any doctor require their hospitalization to psychiatric units.
- •In case they have history of ineffectiveness with electroconvulsive therapy (ECT) or transcranial direct current stimulation (tDCS)
- •In case ECT or tDCS is clinically contraindicated
- •In case they are taking benzodiazepines or antiepileptic drugs on the screening visit
- •In case they scored less than ten on Mini Mental State Exam (MMSE) or scored 3 or more on Clinical Dementia Rating (CDR)
- •In case his/her GDS score is lower than 6 at baseline
- •In case he/she is unable to agree video recording on evaluation interview
结局指标
主要结局
Attrition rate due to any adverse event
时间窗: three weeks
次要结局
- Starkstein Apathy Scale(two, three and five weeks (followup))
- Geriatric Depression Scale(one week, two weeks, three weeks, five weeks (followup))
- Clinical Global Impression of Improvement(one, two, three and five weeks (followup))
- Neuropsychiatric Inventory(three weeks, five weeks (followup))
- Cornell Scale for Depression in Dementia(two weeks, three weeks, five weeks (followup))
- Zarit Burden Interview(three weeks, five weeks (followup))
- Rate of adverse events related to tDCS procedure(three weeks)