Use of 7T Multimodal Imaging to Detect Brain Changes Associated With Light Therapy in Persons With Mild Cognitive Impairment and Mild Alzheimer's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Changes in Perivascular Space Density
研究概览
简要总结
The purpose of this research study is to investigate the effect of a light treatment on sleep, memory and brain function. In people with mild cognitive impairment (MCI) and Alzheimer's disease, sleep-wake disturbance is evident in up to 60% of patients. This can be caused by disruption of circadian rhythms and may affect our health and well-being. Circadian rhythms are the natural cycle of physical, mental, and behavior changes that the body goes through in a 24-hour cycle. Circadian rhythms are mostly affected by light and darkness and are controlled by a small area in the middle of the brain. They can affect sleep, body temperature, hormones, appetite, and other body functions. The circadian system plays an important role in the body and can affect sleep and brain function.
The results of the research would help develop light-delivery methods to improve sleep and memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease who typically spend a significant amount of time indoors.
详细描述
Subjects will be enrolled in the study for 26 weeks. During the first week, subject will come in to Mount Sinai for a study visit to complete a few questionnaires about sleep and mood, complete several memory tests and have an MRI of their brain. These study visits will take about 2 hours to complete. During this week, subject will also be asked to wear a wrist actigraph and light meter for 7 days. The actigraph is similar in size to a watch and is used to record their activity and rest patterns, and the light meter measures the amount of light they are exposed to during the day. After the completion of this week, subject will have a light treatment installed in their home that will be in place for 10 weeks. During the last week of the light treatment, subject will again come into Mount Sinai and repeat the questionnaires, memory tests and MRI, and wear the actigraph and light meter. After a 4-week break, subject will again come into Mount Sinai for a third study visit and complete the same questionnaires, memory tests, and MRI, and wear the actigraph and light meter. After this week, subject will have a different type of light treatment installed in their home and left in place for 10 weeks. During the last week of the light treatment, subject will come into Mount Sinai for the final study visit and complete the questionnaires, memory tests and MRI, and wear the actigraph and light meter for 7 days. There are no costs associated with participation, but subject will receive monetary compensation for each of the 4 study visits.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •the patients must have undergone PET scans to measure amyloid protein accumulation within the past year
- •Those taking antidepressants will be included, but type of medicine and dosage intake will be monitored.
- •50 years and older
- •Eligible participants will be amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) patients with circadian sleep disturbances who reside in their homes, independent living, or assisted living facilities.
- •confirmed amyloid beta positive from an existing ADRC cohort with PET scan (age: 50-85 yrs, 40% M, 60% F; falling between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB)
排除标准
- •Those taking sleep medication will be not included
- •Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis)
- •residence in a skilled nursing facility or long-term care
- •indication for psychiatric hospitalization or acute suicidality in the opinion of the physician
- •recent changes in psychotropics (14 days)
- •major organ failure (e.g., kidney failure)
- •uncontrolled generalized disorders such as hypertension or diabetes
- •obstructing cataracts, macular degeneration, and blindness
- •o Those who have undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm) will also be excluded
- •severe sleep apnea:
- •o Apnea will be screened for using the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ), a 12-item scale yielding scores between 0 and 60.
- •The study will use a score of 29 as a cutoff for men (sensitivity 75%, specificity 65% for sleep apnea), and a cutoff of 26 for women (sensitivity 80%, specificity 67%).
- •restless leg syndrome (RLS):
- •o RLS will be screened for using the International Restless Legs Scale (IRLS), a 10-item scale that yields scores between 0 and 40.4 The study will use a cutoff of greater than or equal to 11 (indicating the presence of symptoms that are at least moderate) as a positive screen for RLS
- •history of:
- •severe photosensitivity dermatitis
- •severe progressive retinal disease (e.g., macular degeneration), or;
- •a permanently dilated pupil (e.g., after certain types of cataract surgery)
- •7T MRI specific exclusions including presence of metallic or biomedical implants (patients can be enrolled at the discretion of the study team and site MRI technicians) and claustrophobia
研究组 & 干预措施
Light Intervention Therapy (LIT) then Sham LIT
The LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT.
干预措施: Lighting Intervention Therapy (Device)
Light Intervention Therapy (LIT) then Sham LIT
The LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT.
干预措施: Sham LIT (Device)
Sham LIT then Light Intervention Therapy
LIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm.
干预措施: Lighting Intervention Therapy (Device)
Sham LIT then Light Intervention Therapy
LIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm.
干预措施: Sham LIT (Device)
结局指标
主要结局
Changes in Perivascular Space Density
时间窗: Baseline and post-therapy at Week 26
Perivascular spaces will be computed from structural scans using automated segmentation methods. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.
Changes in Brian Volumes
时间窗: Baseline and post-therapy at Week 26
Volumes of structures associated with cognitive impairment and AD pathophysiology will be quantified from 7T imaging data. Hippocampal subfield volumes and amygdala subnuclei volumes will be computed. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.
次要结局
- Changes in Functional connectivity as measured by fMRI(Baseline and post-therapy at Week 26)
- Changes in Montreal Cognitive Assessment (MoCA) Score(Baseline and at the end of each intervention period (each intervention period is 10 weeks))
- Changes in Structural connectivity as measured by dMRI(Baseline and post-therapy at Week 26)
- Percentage of Time Spent in Bed Sleeping(7 days/week for 26 weeks)
- Pittsburgh Sleep Quality Index (PSQI) Score(Baseline and every 4 weeks for duration of the study)
- Circadian Stimulus (CS) values using the Daysimeter(During waking hours for 26 weeks)
- Changes in Dementia Quality of Life Instrument (DQoL) Score(Baseline and at the end of each intervention period (each intervention period is 10 weeks))
- Changes Geriatric Depression Scale (GDS) Score(Baseline and at the end of each intervention period (each intervention period is 10 weeks))
研究者
Priti Balchandani
Professor
Icahn School of Medicine at Mount Sinai