WeArable Neuromodulation DeVice for the TrEatment of Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 10
- 主要终点
- Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)
研究概览
简要总结
This is a double- blind, randomized controlled trial with an open label extension designed to evaluate the safety and potential efficacy of a non-invasive brainstem neuromodulation device for treating symptoms associated with Alzheimer's disease (AD).
详细描述
Up to 45 participants will first enter the double-blind, randomized controlled trial during which they will self-administer treatments twice daily in the home setting over 24 weeks with one of two investigational treatment modes. Participants who complete the randomized controlled trial will then enter the open label extension where all participants will self-administer twice-daily treatments over 24 weeks using the same investigational treatment mode that was reported to show benefit in a previous clinical trial in another neurodegenerative disease.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The first 24 weeks will be the randomized controlled portion of the study; the remaining 24 weeks will be an open label extension.
入排标准
- 年龄范围
- 65 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participants (aged 65 - 85 years inclusive) diagnosed with probable Alzheimer's disease dementia .
- •Willing and able to comply with study requirements.
- •Have a study partner who sees the participant for more than three hours a day, 5x per week and is that is willing to consent and participate in the trial.
- •Anticipation that the participant is able to remain on a stable regimen of medications used for the management of Alzheimer's disease and will not introduce new medications used to treat Alzheimer's disease during the study.
- •Participant and study partner must both be fully vaccinated from COVID-19 prior to the study screen
排除标准
- •Were diagnosed with probable Alzheimer's disease prior to 65 years of age.
- •Has experienced a heart attack, angina, or stroke within the past 12 months or a transient ischemic attack (TIA) within the past 6 months.
- •Are being treated with another neurostimulation device
- •Experience frequent falls
- •Works night shifts.
- •Have unresolved complications from a previous surgical procedure at the baseline visit, such as swelling or persistent pain, that requires medical intervention.
- •Have active ear infections, or other significant ear problems.
- •Have a recent history of frequent ear infections
- •Have a cochlear implant or hearing aids that cannot be easily/reliably removed for treatment.
- •Have chronic tinnitus.
- •Have previously been diagnosed with traumatic brain injury with ongoing sequela.
- •History of medication-refractory depression or bipolar disorder in the past three years.
- •History of schizophrenia.
- •Participation in an interventional clinical trial for any medical or psychiatric indications within 3 months of the screening visit, or at any time during the study.
结局指标
主要结局
Change from baseline in the Alzheimer's Disease Assessment Scale-Cognitive-Plus (ADAS-Cog-14)
时间窗: 24 weeks
The ADAS-Cog-14 is a modified version of the Alzheimer's Disease Assessment Scale - Cognitive Subscale - a brief neuropsychological assessment developed to assess the level of cognitive dysfunction in AD. The scoring range is from 0 to 90, with higher scores indicating greater cognitive impairment.
次要结局
- Change from baseline in the Alzheimer's Disease Cooperative Study - instrumental Activities of Daily Living (ADCS-iADL).(24 weeks)
- Change from baseline in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS-CGIC).(24 weeks)