Acute Treatment of Alzheimer's Disease With Gamma Frequency Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Safety of gamma frequency stimulation
研究概览
简要总结
Alzheimer's disease (AD) is characterized by significant memory loss and toxic protein deposits (amyloid and tau) in the brain. The investigators' lab found a non-invasive way to remove these toxic proteins from the brain in AD mouse models. Remarkably, treated mice also have improved memory on behavioral testing. The investigators aim to translate this non-invasive method, which uses light and sound to stimulate the brain, to be used in mild Alzheimer's patients. 40 participants with mild Alzheimer's disease will be recruited, and the investigators will assess their brain waves with electroencephalogram (EEG) before, during, and after light and sound stimulation for safety, feasibility, and to optimize the stimulation device for use in the mild AD population.
详细描述
It is known that Alzheimer's disease (AD) patients have significant disruptions in brain waves, especially the gamma frequency (~30 - 100 Hz) waves. Recently, the investigators' lab found that gamma entrainment using light and sound stimulation, which the investigators call GENUS, improves memory and decreases toxic accumulation of amyloid and tau in AD mouse models. This study aims to translate these findings in the mouse models to be used in mild Alzheimer's patients. The investigators will recruit 40 patients diagnosed with mild AD who will be randomly assigned to two study arms. Cognitive and mental health evaluations as well as memory tests will be performed on all subjects. All subjects will also be exposed to the GENUS device, which can deliver light and sound waves at different frequencies. The GENUS device is composed of a panel with light-emitting diode (LED) illumination and speakers for auditory stimulation. Each of the 2 groups will have different combinations of light and sound settings. The investigators will use electroencephalography (EEG) to check for how the participant's brain waves respond to the stimulation, and use questionnaires to evaluate for safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is between the ages of 50 -
- •Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -
- •Subject is willing to sign informed consent document.
- •If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.
排除标准
- •Subjects who do not have healthcare.
- •Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
- •Subjects on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
- •Subjects with history of seizure or epilepsy within the past 24 months.
- •Subjects with clinically significant suicide risk and/or suicide attempt in the past 1 year.
- •Subjects with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
- •Active treatment with one or more anti-epileptic agent.
- •Subjects who have had a stroke within the past 24 months.
- •Subjects diagnosed with migraine headache.
- •Active treatment with one or more psychiatric agent (e.g. antidepressants, antipsychotics, etc).
- •Subjects who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
- •Subjects who have profound hearing or visual impairment.
- •Subjects who have a life expectancy of less than 2 years.
- •Subjects who are pregnant.
结局指标
主要结局
Safety of gamma frequency stimulation
时间窗: Immediately after the completion of the stimulation
Safety of gamma frequency stimulation will be assessed by using a questionnaire asking for any adverse effects of the stimulation.
Feasibility of gamma frequency stimulation
时间窗: Immediately after the completion of the stimulation
Feasibility of gamma frequency stimulation in subjects with mild AD will be assessed by analyzing the EEG data from each subject for a sign of change in gamma frequency waves and determining the percent of subjects who show this change.
Tolerability of gamma frequency stimulation
时间窗: Immediately after the completion of the stimulation
Tolerability of gamma frequency stimulation will be assessed by using a questionnaire asking for the subjects' overall experience with the stimulation.
次要结局
未报告次要终点