A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma Device for the Treatment of Moderate-to-severe Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.
研究概览
简要总结
This study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.
详细描述
The Neuro RX Gamma system is a headset which emits pulsed near-infrared energy synchronously or asynchronously through diodes placed on the scalp and inside a nostril.
A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment synchronized, treatment asynchronized or sham (placebo). A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. Participants will have the choice of opting into a substudy involving the collection of rest EEG recordings during the baseline and weeks 3, 6 and 12 visits.
60 patients will be enrolled in 2 clinical sites in Ontario, Canada.
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)
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
- •Age is greater than or equal to 50 years old
- •Meets the criteria for probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- •If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months
- •Mini Mental State Examination (MMSE) score between 0-20 at screening assessment
- •Severe Impairment Battery score at baseline of ≤90
- •Outpatient with a reliable caregiver willing to commit to study visits and procedures
排除标准
- •Current psychiatric or other neurologic disease
- •Any history of stroke, seizures, light sensitivity (polymorphous light eruption, solar urticaria, persistent light reactivity) or Lyme disease, including those taking photosensitizing medication
- •Currently undergoing light therapy treatment
- •Increased skin sensitivity at the treatment site including active herpes simplex in the treatment area, history of keloid formation, or history of retinoid use in the past month
- •Pregnant or lactating or planning to become pregnant
- •Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments
- •Does not speak English at a level necessary for the completion of the assessments.
- •Currently participating in another clinical research study involving an investigational product.
- •Has participated in a drug or device study within the last 30 days.
- •Any condition, such as agitation/aggression, that in the opinion of the investigator would cause the patient to be unable to comply with study procedures
结局指标
主要结局
Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.
时间窗: Baseline to Week 12
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
次要结局
- Device safety according to the number of device-related adverse events(Baseline to Week 12)
- Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.(Baseline to Week 6)
- Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score(Baseline to Week 12)
- Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.(Baseline to Week 12)
- Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.(Baseline to Week 12)
- Change in the Electroencephalogram's (EEG) overall power spectral density(Baseline to Week 12)