Efficacy and Safety of Near Infrared Light Therapy for Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from baseline in ADAS-cog
研究概览
简要总结
To explore the efficacy and safety of near infrared light therapy for Alzheimer's disease. Each subject will be numbered and their medical records will be established. The subjects will be randomly assigned to the treatment group or the control group for 30 minutes/day (5-6 days a week) for 4 months while the treatment group is active settings and the control group is sham settings.Follow-up visits will be conducted at 2 months, 4 months and 2 months after treatment. At each follow-up, scale assessment, blood, MRI, and EEG were observed
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
- Triple (Participant, Care Provider, 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
- •The age of registration is 50-85 years old, male or female.
- •The MMSE score < 26 points can be used to complete the scale assessment.
- •Patients who are not on medication and who are taking psychotropic or cognitive-improving drugs must have a stable dose for at least 12 weeks before the trial and remain the same for the duration of treatment.
- •Agree to participate in the clinical trial, willing to maintain the original treatment plan during the trial, and have signed the informed consent
排除标准
- •MRI showed evidence of abnormalities other than Alzheimer's disease, such as cerebral infarction at key sites and severe leukodystrophy (Fezakas>Level 3).
- •There are contraindications to MRI scanning, such as metal implants, claustrophobia, etc.
- •A history of stroke or seizures.
- •Photosensitive to sunlight or visible light, eczema or increased sensitivity of the skin at the treatment site.
- •Severe vision or hearing impairment.
- •Alcohol dependence, drug or other drug addiction or addiction tendency.
- •During the study , subjects were pregnant, breastfeeding, or planning to pregnancy.
- •He/She is currently participating in another study related to the treatment of AD.
- •Researchers think that participants could not be included.
结局指标
主要结局
Change from baseline in ADAS-cog
时间窗: 8 weeks, 16 weeks and 24 weeks
Alzheimer's Disease Assessment Scale - Cognitive section ,ADAS-Cog；The higher the score, the worse.
Change from baseline in MMSE
时间窗: 8 weeks, 16 weeks and 24 weeks
(Mini-Mental State Examination, MMSE ;The higher the score, the better.
Change from baseline in ALFF
时间窗: 8 weeks, 16 weeks and 24 weeks
The amplitudeof low-frequency fluctuations, ALFF;The increase of ALFF indicates that neuronal excitability and metabolism are enhanced, while the decrease of ALFF indicates that neuronal spontaneous activity is inhibited.
次要结局
- Change from baseline in ADCS-ADL(8 weeks, 16 weeks and 24 weeks)
- Change from baseline in MOCA(8 weeks, 16 weeks and 24 weeks)
- Change from baseline in ADCS-CGIC(8 weeks, 16 weeks and 24 weeks)
- Change from baseline in NPI(8 weeks, 16 weeks and 24 weeks)
- Change from baseline in HAMD(8 weeks, 16 weeks and 24 weeks)
- Aβ amyloid and tau levels(8 weeks, 16 weeks and 24 weeks)
- MRI(8 weeks, 16 weeks and 24 weeks)