Effects of PEMF Treatment on Patients With Mild to Moderate Alzheimer's Disease in a Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
研究概览
简要总结
An open label pilot study in mild to moderate AD patients to assess the effects of treatment with ECHS AD pulsed electromagnetic treatment device on disease progression. Enrolled patients will receive active devices. They will treat themselves at home three times a day for 15 minutes over 120 days. Primary end points are the The Alzheimer's Disease Assessment Scale-Cognitive Subscale and the Mini-Mental State Exam. Participants will be followed-up for 9 months post-treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Age ≥ 50 years
- •Patients diagnosed with mild to moderate Alzheimer's Dementia defi
- •At least an eighth grade of educational achievement
- •If female, post-menopausal.
- •MMSE score between 16 and 26
- •Capable of providing consent or having a surrogate (e.g., spouse, family member) capable of providing consent if participant lacks consent capacity
- •Able and willing to comply with the protocol
- •If the participant is receiving a cholinesterase inhibitor and/or memantine, such medication has been prescribed for at least 3 months prior to screening and the dose is stable for at least 60 days prior to screening (that dose needs to be maintained throughout the period of this study)
- •Spouse, family member or professional caregiver agree and are capable of taking care of the participation of the patient in the study (answering questions regarding the patient's condition, assuming responsibility for medication, and applying and supervising the daily PEMF treatments)
- •Physical clearance for study participation as evaluated by the clinician
排除标准
- •The patient lacks capacity to consent to study participation and no surrogate is available to provide consent
- •History of epileptic seizures or epilepsy
- •Currently taking medication that lowers the seizure threshold
- •Presence of depression, bipolar disorder, a psychotic disorder, or any other neurological or psychiatric condition (whether now or in the past), which the Investigator finds as interfering with the study
- •Severe agitation that would interfere with study procedures
- •Alcoholism or substance use disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) within last 5 years (addicted more than one year and or in remission less than 3 years) or severe sleep deprivation
- •Major surgery (defined as any major abdominal, vascular or thoracic surgery requiring general anesthesia and resulting in a period of >1 week hospitalization) within 4 weeks
- •Head anatomy that interferes with the fit of the treatment device
- •Participation in another clinical trial within the previous 30 days
- •Metal implants in the head, (i.e., cochlear implants, implanted brain stimulators and neurostimulators, aneurysm clips) with the exception of metal implants in mouth
研究组 & 干预措施
Active ECHS AD device
Experimental intervention arm
干预措施: ECHS AD Device (Device)
结局指标
主要结局
The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)
时间窗: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Assessment consisting of 11 tasks, taking up to 30mins, to measure the severity of cognitive dementia symptoms. Score 0-70, Higher number, more severity.
Global Deterioration questionnaire
时间窗: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Quality of Life Scale
时间窗: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scored 0-7, higher score, greater severity
Mini-Mental Status Exam (MMSE)
时间窗: Change between day 0, and 30, 60, 90, 120, 150, 240, 310, 400 days
Clinician assessment of cognitive impairment. Scoring 0-30, lower score, more severity
次要结局
未报告次要终点