Phase 2 (Feasibility) Study of Transcranial Magnetic Stimulation as Additional Therapy to Drug Treatment in Patients With Alzheimer's Disease
试验速览
- 阶段
- 2 期
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- ADAS-COG
研究概览
简要总结
The primary objective of this trial is to assess the ability of Transcranial Magnetic Stimulation with H2 coil to prefrontal and parieto-temporal cortex to improve cognitive performance in patients with Alzheimer's disease which received drug treatment. This study is a single-center, double-blind 4 months duration trial.
详细描述
Primary outcome measure: ADAS-COG (time frame baseline, 2 months, 4 months) Secondary outcome measure: CGI-C, Neuropsychological computerized test (Mindstream), FAB,ADL, Beck Depression Inventory-time frame baseline,1 month (visit 12) 2 months (visit 16), 4 months (visit 17).
Estimated enrollment: 45 patients Estimated Study start Date: November 2008 Estimated Study Completion date: November 2012 Number of arms: 3 Interventions details: H2 coil device for Transcranial Magnetic Stimulation with MAGSTIM to prefrontal and parieto-temporal regions bilaterally with frequency 10Hz in one arm, 1Hz in the second arm, and sham-stimulation with frequency 10Hz/1Hz in third arm.
Ages: 50-80 Genders: both
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, Care Provider, Investigator)
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent will be obtained
- •diagnostic evidence of probable AD consistent with DSM IV
- •stable treatment with Acetylcholine-Esterase Inhibitors or/and Memantine for 5 weeks prior to screening
- •stable dose treatment with other drugs
- •MMSE <25
排除标准
- •Patients with neurological or psychiatric disorders that affect cognition but are distinguishable from AD
- •Patients who are unwilling or unable to fulfill the requirements of the study
- •Severe personality disorder
- •Malignant or untreated Hypertension
- •History of Epilepsy
- •History of Head trauma
- •Metal implant in head, cardiac pacemaker, medical pump
- •Drug or alcohol addiction
- •Involvement in any other clinical trial during the preceding 3 month
- •Patient who are unwilling or unable to give Informed Consent
结局指标
主要结局
ADAS-COG
时间窗: Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17)
次要结局
- CGI-C, Neuropsychological computerized test (Mindstream),CGI-C,FAB,ADL, Beck Depression Inventory.(Baseline, 1 month (visit 12), 2 months (visit 16), 4 months (visit 17))
研究者
Michal Roll PhD,MBA
Dr. Alissa Ash
Tel-Aviv Sourasky Medical Center