Multi-Center Study of Sensory Stimulation to Improve Brain Function (Overture Study)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
- 试验地点
- 9
- 主要终点
- Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
The Overture Study is a randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation system to study safety, tolerability, and efficacy in people with mild to moderate cognitive impairment.
详细描述
The Overture Study (CA-0005) is a Phase I/II randomized, controlled, single-blind multi-center clinical trial using the GammaSense Stimulation device to study safety, adherence rates and efficacy in subjects with mild to moderate cognitive impairment (MMSE 14-26) who are age 55 and older.
Subjects who pass screening will be randomized (ratio 2:1 Treatment to Control). Subjects and their caregivers will be blinded to their randomization group, as will key raters at each site. The device will be used for 60 minutes daily during the 6-month therapy phase, followed by a one month safety follow-up visit.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>= 55 Years old
- •MMSE 14-26
- •Prodromal Alzheimer's Disease (AD), AD or Mild Cognitive Impairment (MCI) due to AD
- •Participation of a caregiver
排除标准
- •Profound hearing or visual impairment
- •Seizure Disorder
- •Use of memantine (Namenda or Namzaric)
- •Implantable devices (non-MR compatible)
结局指标
主要结局
Alzheimer's Disease Assessment Scale- Cognitive Subscale (ADAS-Cog)
时间窗: Quarterly over 6 months
A widely accepted, validated measure of cognitive function in Alzheimer's Disease consisting of 14 questions that result in a score ranging from 0 to 90 with higher scores representing greater cognitive impairment
次要结局
- Amyloid PET/CT(Quarterly over 6 months)