Neurostimulation and Cognitive Intervention in Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
研究概览
简要总结
This study is a double blind, sham-controlled clinical trial aiming to compare the long-term effects of stimulation in Alzheimer's Disease (AD). Sixty early AD patients will take part in a phase II/III clinical study over a 1-year period. The study involves transcranial direct current stimulation (tDCS), cognitive training (CT), detailed neuropsychological and neurological testing. These assessments will occur at baseline, then again at two month (end point). Those who achieve clinical improvement with neurostimulation and cognitive therapy will be invited to receive treatment for 12 months as part of a follow-up study.
详细描述
The patients will be randomized into 1 of 4 groups: active tDCS plus real CT, active tDCS plus placebo CT, sham tDCS plus real CT, sham tDCS plus placebo CT. Each group will receive treatment for 30 minutes a day, 3 days a week for 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female age 60-90 years
- •Patients diagnosed with Alzheimer's Disease, according to the DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) and NINCDS-ADRDA (National Institute for Communicative Disorders and Stroke - Alzheimer's Disease and Related Disorders Association) criteria
- •Score between 18 and 26 on the Mini Mental State Examination
- •Have a CDR (Clinical Dementia Rating) of 1.0
- •If medicated for AD, then use of cholinesterase inhibitors, for at least 3 months and on stable dose for at least 60 days prior to screening.
排除标准
- •Pre-existing structural brain abnormalities,
- •Other neurologic or psychiatric diagnoses
- •Transcranial direct current stimulation criteria: patients with implanted metallic or electronic devices; pacemaker; seizures; pregnancy; any other condition that might limit or interfere in the sensorimotor system
结局指标
主要结局
Change in cognitive function assessed on the Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-Cog)
时间窗: Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months)
次要结局
- Change in cognitive ability assessed on the Wechsler Adult Intelligence Scale(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in executive function assessed on the Stroop Color and Word Test(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in verbal fluency assessed on the FAS Verbal Fluency Test(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in visual recognition assessed on the Poppelreuter-Ghent's Overlapping Figures test(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in visuo-spatial working memory assessed on the Corsi block task(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in behavioral and psychological disturbances assessed on the Neuropsychiatric Inventory Questionnaire(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in verbal working memory assessed on the Digit Span task(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in speed of cognitive processing and executive functioning assessed on the Trail Making Test(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in subjective burden among caregivers assessed on the Zarit Burden Interview(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Side Effects Questionnaire(From date of first neurostimulation until the date of last neurostimulation, assessed up to 12 months)
- Change in functional ability assessed on the Disability Assessment Dementia(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
- Change in electrical activity of the brain assessed on the Electroencephalogram (EEG)(Baseline (week 1), Endpoint (week 8) and Follow up (assessed up to 12 months))
研究者
Suellen Marinho Andrade
Professor
Federal University of Paraíba