ALZLIGHT Pilot: Study on Safety, Feasibility and Neural Activation of Non-Invasive Light Therapy System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Stage I: Usability Assessment:
研究概览
简要总结
Induction of neural oscillations by flickering light is a well established method used for diagnostic of various neural diseases.
Recent studies in mice have shown promising results indicating that induction of gamma oscillation at 40 Hz leads to a reduction in amyloid-β and tau in mice models of Alzheimer's disease. This study will use flickering light to induce 40 Hz gamma oscillation as the previously mentioned studies.
In the study subject will be exposed to invisible spectral flickering light (active setting) or continuous non-flickering white light (sham setting) for 1 hour each day. The sham setting is a high quality sham intervention as subjects will be blinded to the setting, both appears as white light.
As this is the first trial, the focus will be on 1) safety of the intervention 2) feasibility of the proposed intervention time and method 3) indication of efficacy.
In stage 1 of the trial 4 age-matched subjects with no Alzheimer's disease will be recruited and be exposed for 1 week. In stage 2 10 patients with Alzheimer's disease will be recruited and exposed for 6 consecutive weeks.
详细描述
Induction of neural oscillations by flickering light is a well established method used for diagnostic of various neural diseases (5,6).
Recent studies in mice have shown promising results indicating that induction of gamma oscillation at 40 Hz leads to a reduction in amyloid-β an tau in mice models of Alzheimer's disease (1-4). This study will use flickering light to induce 40 Hz gamma oscillation as the previously mentioned studies.
This study will utilize a novel way of masking the light by alternating the spectral composition of a white light, rendering the flicker invisible to the conscience perception while still entraining 40 Hz oscillations in the brain.
In the study subject will be exposed to invisible spectral flickering light (active setting) or continuous non-flickering white light (sham setting) for 1 hour each day. The sham setting is a high quality sham intervention as subjects will be blinded to the setting, both appears as white light.
As this is the first trial, the focus will be on 1) safety of the intervention 2) feasibility of the proposed intervention time and method 3) indication of efficacy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult competent persons able to understand the nature of the study and give written informed consent.
- •Stage I: Healthy elderly subject.
- •Stage II: Diagnosed with probable mild to moderate AD based on NIA-AA diagnostic criteria.
- •Age >55 years and <80 years. Females must be post-menopausal.
- •Fluent in Danish
- •> 8 year of normal school education
- •Pass a colour-blindness test (Ishihara colour test)
- •Have visual and auditory capabilities, and language skills necessary for neuropsychological testing.
- •Furthermore, subjects must have a person, hereafter named designated caregiver, who is available to the participant and can provide the necessary assistance with using the LTS device and Actigraph wearable at home and can assist with clinic visits and other practical issues.
排除标准
- •Profound visual impairment provided correction with spectacles, if needed.
- •Significant abnormalities related to important parts of the brain e.g. the visual system, pre-frontal cortex or hippocampus, or relevant lesions detected by MRI.
- •Prior history of significant diseases related to the visual system or the brain.
- •Medication Any patient using antiepileptic drugs, neuromodulating drugs or high dose of sedatives will be excluded.
- •Prior history of substance abuse within the past 2 years.
- •Any significant systemic illness or unstable medical condition, which could lead to difficulty complying with the protocol.
结局指标
主要结局
Stage I: Usability Assessment:
时间窗: After 1 week of intervention
• Usability report on use of device during intervention in the subject's home based on device speciffic questionnaire / structured interviews
Stage I: Safety Assessment. Evaluation of Adverse Events related to the LTS intervention.
时间窗: After 1 week of intervention
• Safety assessment will be done by collection of all types of adverse events and categorization into severity and relationship to LTS treatment.
Stage II: Safety Assessment. Evaluation of Adverse Events related to the LTS intervention.
时间窗: After 6 weeks of intervention and subsequent 6 weeks of no intervention
• Device- and procedure-related adverse events (DR/PR-AEs) including serious AEs (SAEs) occurring at any time during the trial
Stage II: Feasibility / Compliance assesment
时间窗: After 6 weeks of intervention and subsequent 6 weeks of no intervention
• The compliance of the LTS intervention will be measured by the amount of time (in minutes) of device use per day.
Stage I: Feasibility / Compliance assesment
时间窗: After 1 week of intervention
• The compliance of the LTS intervention will be measured by the amount of time (in minutes) of device use per day.
次要结局
- Stage II: Connectivity meassures in EEG(Changes from baseline to 6 and 12 weeks)
- Stage II: Induction of gamma ocsillations(Changes from baseline to 6 and 12 weeks)
- Stage II: Connectivity meassures in resting-state functional MRI(Changes from baseline to 6 and 12 weeks)