Multi-Center Study of Tolerability, Safety and Efficacy of Sensory Stimulation at Multiple Dose Levels to Improve Brain Function (Etude Study)
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adverse Events
研究概览
简要总结
The Etude Study is a multi-center, four-arm prospective dose-adjusting study designed to assess the tolerability, safety and efficacy of non-invasive sensory stimulation for patients with cognitive impairment.
详细描述
Subjects will be enrolled in two Cohorts (N=10 each, enrolled sequentially), and each will assess two different dose levels (randomly assigned). Based on initial outcomes in Cohort 1 at Interim Analysis, the doses for Cohort 2 will be escalated or decreased. Subjects will participate in 1 year (48 weeks) of daily therapy dose using the non-invasive, non-significant risk sensory stimulation medical device.
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
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 50 Years Old
- •MMSE 24 - 30
- •Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- •Participation of a caregiver / care partner
- •Amyloid Positive PET Scan
排除标准
- •Profound hearing or visual impairment
- •Seizure Disorder
- •Use of memantine (Namenda or Namzaric)
- •Implantable devices (non-MR compatible)
研究组 & 干预措施
Cohort 1, Arm A
Dosing 1 hour session per day with GammaSense Stimulation System (non-invasive, non-significant risk)
干预措施: GammaSense Stimulation System (non-invasive, non-significant risk) (Device)
Cohort 1, Arm B
Dosing 1 hour session twice per day with GammaSense Stimulation System (non-invasive, non-significant risk)
干预措施: GammaSense Stimulation System (non-invasive, non-significant risk) (Device)
Cohort 2, Arm C
Dosing 1 hour session every other day or one 2 hour session per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)
干预措施: GammaSense Stimulation System (non-invasive, non-significant risk) (Device)
Cohort 2, Arm D
Dosing 30 minute session twice per day or 120 minute session twice per day, depending on Interim Analysis outcomes with GammaSense Stimulation System (non-invasive, non-significant risk)
干预措施: GammaSense Stimulation System (non-invasive, non-significant risk) (Device)
结局指标
主要结局
Adverse Events
时间窗: Over 12 months
Composite adverse events to be assessed at Interim Analysis (at any point in partial study completion), and final analysis (at 6 and 12 months time points).
Change in Amyloid Positron Emission Tomography (PET) Scan
时间窗: PET Imaging at Baseline, 6 weeks and every 3 months throughout therapy (0, 1.5, 3, 6, 9 and 12 month)
Movement of amyloid, as measured qualitatively and quantitatively in Amyloid PET Imaging at 0, 1.5, 3, 6, 9 and 12 months following assigned regimen of sensory stimulation treatment sessions
次要结局
- Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)(Baseline, 3, 6, 9 and 12 months)