Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in apathy symptoms
研究概览
简要总结
We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.
详细描述
This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion.
Eligibility criteria:
- Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20);
- Diagnosis of apathy;
- age between 60 and 85 years-old;
- On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment;
The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 60 to 85 years-old
- •Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20)
- •Apathy diagnosis
- •On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment
排除标准
- •history of epilepsy or convulsions
- •History of migraine or headaches episodes twice per week or more
- •History of neurodegenerative diseases other than Alzheimer's disease
- •Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants
- •History of cerebral ischemic episode
结局指标
主要结局
Change in apathy symptoms
时间窗: 12 weeks
Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.
次要结局
- Change in ADAS-Cog scores(12 weeks)
- Change in the Zarit Burden Scale(12 weeks)
研究者
Breno Satler de Oliveira Diniz
Assistant Professor
Federal University of Minas Gerais