A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma for the Treatment of Amnestic Mild Cognitive Impairment (aMCI)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE)
研究概览
简要总结
Over 50 million people worldwide are currently living with dementia-a number projected to rise to 152 million by 2050. Mitochondrial dysfunction in the brains of individuals with Mild Cognitive Impairment (MCI) and Alzheimer's Disease (AD) has gained increasing attention as a potential mechanism and therapeutic target. However, no effective treatment specifically targeting mitochondrial function is currently available.
Photobiomodulation (PBM) is an innovative, non-invasive technique that delivers near-infrared light transcranially to the brain. PBM is believed to enhance mitochondrial function-particularly in tissues with high mitochondrial density such as the brain-by reducing oxidative stress and increasing ATP production. It can be safely administered to awake outpatients and does not require general anesthesia or surgical intervention. While preclinical and case studies suggest PBM may be beneficial in AD, the absence of placebo-controlled trials and objective biomarkers has limited understanding of its effectiveness and underlying mechanisms.
Objectives: This pilot feasibility study aims to assess cognitive outcomes and neural correlates associated with PBM in individuals with early amnestic MCI (aMCI). Participants who meet eligibility criteria (n = 20) will undergo a 6-week, home-based PBM intervention using the Neuro Rx Gamma device (6 days/week, 20 minutes/session). Clinical and cognitive assessments, blood sample collection, and structural and resting-state functional MRI scans will be conducted at two time points: baseline and post-treatment. These assessments will enable evaluation of PBM's effects on cognition and brain function, with particular focus on mitochondrial-related mechanisms.
This study offers a unique opportunity to investigate whether PBM can modulate mitochondrial and neural processes associated with cognitive decline in aMCI.
详细描述
Intervention:
The experimental intervention will be the Vielight Neuro RX Gamma photobiomodulation (PBM) device, which delivers near-infrared light via five light-emitting diodes (LEDs) operating at a wavelength of 810 nm. The LEDs are positioned equidistantly on the scalp and intranasally to target key brain regions. The device generates no significant heat, enabling the use of an indistinguishable sham device for placebo control.
All participants will self-administer 20-minute sessions once daily, six days per week, for six weeks. Subjects and/or caregivers will receive training to ensure proper at-home use and will be asked to maintain a treatment diary to monitor adherence.
Assessments:
Each participant will undergo two in-person visits-at baseline (T0) and post-intervention (week 7; T2)-to complete the following evaluations:
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
- Single (Participant)
盲法说明
This is a randomized, single-blind trial. The trial will include patients with amnestic MCI who will be randomized in a 1:1 ratio to treatment with an active or sham Neuro RX Gamma device.
入排标准
- 年龄范围
- 50 Years 至 95 Years（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 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for MCI due to Alzheimer's disease.
- •Essentially normal functional activities as derived from the CDR.
- •If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months.
- •MoCA score between 19 and 25 at screening assessment and impairment in learning and memory domain.
排除标准
- •Cannot tolerate blood draws.
- •Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners.
- •A pace-maker or other metal implants that would preclude safe use of MRI.
- •DSM 5 diagnosis of alcohol or other substance use disorders within the past 12 months.
- •Unstable medical illness, (e.g., uncontrolled diabetes mellitus or hypertension).
- •Any history of stroke, seizures, MS, light sensitivity or Lyme disease.
- •Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments.
- •Participant or caregiver does not speak English at a level necessary for the completion of the assessments.
- •Has not completed at least a grade eight education, as necessary for the completion of the assessments.
- •Currently participating in another clinical research study involving an investigational product.
- •History of significant agitation and/or aggression, epileptic seizures.
- •Current neurologic disease affecting cognition other than Alzheimer's disease.
- •Photosensitivity reactions to sunlight or visible light (polymorphous light eruption, solar urticaria, persistent light reactivity).
- •History of recurrent epistaxis within the last 24 weeks or currently taking major anti-coagulants (including warfarin, low molecular weight heparin)
- •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.
- •Currently undergoing light therapy treatment.
- •Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial.
结局指标
主要结局
Changes from pre- to post-treatment on mental status and cognitive function assessed by Mini-Mental State Examination (MMSE)
时间窗: Assessed at baseline and post-intervention (week 7)
MMSE is a brief 30-point assessment
Changes from pre- to post-treatment on verbal learning and memory assessed by California Verbal Learning Test-II (CVLT-II)
时间窗: Assessed at baseline and post-intervention (week 7)
The Composite Score was created by grouping variables into domains and averaging the domains into a single Composite Score for each participant using: CVLT-II - Total Recall Trials 1-5 CVLT-II - d' Hits and False Alarms of recognition Yes/No responses CVLT-II - Percent retained at long delay trial from trial 5 at immediate recall condition
Changes from pre- to post-treatment on processing speed assessed by Trail Making Test (TMT)-part A & B
时间窗: Assessed at baseline and post-intervention (week 7)
Trail Making A - Time per correct connection
次要结局
- Changes from pre- to post-treatment on peripheral blood-biomarkers assessed by blood(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on structural MRI (T1-weighted imaging)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on brain metabolites (PCC)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on resting state functional connectivity of the default mode network (DMN) via rs-fMRI(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on cerebral blood flow (CBF)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on structural MRI (Diffusion tensor imaging - DTI)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on Pittsburgh sleep quality index(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on peripheral blood-biomarkers assessed by blood(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on plasma biomarkers(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on Neuropsychiatric symptoms (NPS) using MBI-C (Mild Behavioral Impairment Checklist)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on structural MRI (T1-weighted imaging)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on brain metabolites (PCC)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on structural MRI (Diffusion tensor imaging - DTI)(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on resting state functional connectivity of the default mode network (DMN) via rs-fMRI(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on Pittsburgh sleep quality index(Assessed at baseline and post-intervention (week 7))
- Changes from pre- to post-treatment on cerebral blood flow (CBF)(Assessed at baseline and post-intervention (week 7))
研究者
Corinne Fischer
Professor of Psychiatry, University of Toronto
University of Toronto