A Longitudinal Study Investigating the Effects of Photobiomodulation (PBM) on Cognitive Function and Alzheimer's Disease (AD)-Related Biomarkers in Individuals With Mild Cognitive Impairment (MCI) or Dementia Due to AD
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- NIH Toolbox
研究概览
简要总结
The purpose of this study is to see if a special light treatment, called photobiomodulation, can help people with memory problems such as Mild Cognitive Impairment or Mild Dementia due to Alzheimer's disease. The light is given to the forehead using an FDA-cleared medical device. This device is cleared to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue. This device is being used "off-label," meaning it will be used in a way that is different than its cleared use.
We want to learn whether this light treatment can improve executive function, and whether it changes certain inflammatory and neurodegeneration related signals in the blood. To do this, we will apply the photobiomodulation device to your forehead. We will also ask you questions and give you cognitive tests before and after light treatment. We will also collect blood samples before and after treatment.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed and dated informed consent form (either by subject or LAR)
- •Willingness and ability to comply with all study procedures
- •Age 55 to 89 years, inclusive
- •Clinical diagnosis of Mild Cognitive Impairment or mild dementia (CDR Global = 0-1; MoCA 16-25) due to probable Alzheimer's disease diagnosis
- •Ability to attend in-person sessions at Cedars-Sinai and adhere to weekly visits
- •Stable dose of Alzheimer's disease medications (e.g., donepezil, rivastigmine, memantine, galantamine) for at least 4 weeks prior to enrollment, if applicable
排除标准
- •Presence of significant neurological conditions other than AD (e.g., epilepsy, Parkinson, etc.)
- •History of Seizures
- •If patient holds neuroimaging showing space-occupying lesions
- •If patient holds imaging with Fazekas greater than or equal to 3, more than 2 lacunar infarcts, and/or more than 5 microhemorrhages
- •Current pregnancy or lactation (although unlikely in this population)
- •Participation in another clinical trial or investigational drug within the past 30 days
- •Active use of illicit substances or non-prescribed psychoactive drugs within the past 30 days.
- •Severe dementia due to Alzheimer's disease or another etiology
- •Physical or mental impairment that prevents the participant from complying with the cognitive testing battery.
研究组 & 干预措施
Active photobiomodulation
1064nm photobiomodulation to be applied for 8 minutes total each session
干预措施: Photobiomodulation (Device)
Sham
only 5 seconds of photobiomodulation, to account for small amount of participants who reported an initial warm sensation upon stimulation
干预措施: Photobiomodulation (Device)
结局指标
主要结局
NIH Toolbox
时间窗: Baseline measurements will be performed prior to intervention, post-treatment (week 5), and lastly at the 3-month follow-up visit
Three validated NIH Toolbox tasks: 1. Dimensional Change Card Sort Task (measure of cognitive flexibility) 2. Flanker Inhibitory Control and Attention Test (a measure of inhibitory control and selective attention), 3. Visual Reasoning Test (non-verbal and visual reasoning)
次要结局
- Glial Fibrillary Acidic Protein (GFAP)(Will be performed at baseline and at 3 month follow up)
- Neurofilament Light Chain (NfL)(Baseline and 3-month follow up)
- Total Tau(Baseline and 3-month follow up)
- Interferon-γ (IFN-γ)(Baseline and 3-month follow up)
- Interleukin-1β (IL-1β)(Baseline and 3-month follow up)
- Tumor Necrosis Factor-α (TNF-α)(Baseline and 3-month follow up)
研究者
Golnaz Yadollahikhales
Principal Investigator
Cedars-Sinai Medical Center