Neuro RX Gamma for Amnestic Mild Cognitive Impairment (aMCI)
A legfontosabb adatok
- Ki végzi
- Unity Health Toronto
- Hol
- Kanada1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Fázis
- Korai 1. fázis
- Résztvevők
- 20 fő vett részt
- Kezdés
- 2023. márc. 28.
- Befejezés
- 2025. febr. 3.
- A vizsgálat típusa
- Beavatkozással járó, 2 csoportAz egyik csoport egy már használt kezelést kap, összehasonlításként.
- A vizsgált kezelések
- Neuro RX Gamma device
- Sham Neuro RX Gamma device
- A regiszteradat frissítve
- 2025. július 24.
Ki vehet részt
- Életkor
- 50 év – 95 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 23 feltétel megnézéseKevesebb
Ki vehet részt
- 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
Ki nem vehet részt
- A pace-maker or other metal implants that would preclude safe use of MRI
- Currently participating in another clinical research study involving an investigational product
- History of recurrent epistaxis within the last 24 weeks or currently taking major anti-coagulants (including warfarin, low molecular weight heparin)
- Currently undergoing light therapy treatment
- 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
- History of significant agitation and/or aggression, epileptic seizures
- Current neurologic disease affecting cognition other than Alzheimer's disease
- 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
- Cannot tolerate blood draws
- Claustrophobia (fear of small or enclosed spaces), that cannot tolerate MRI scanners
- 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
- Photosensitivity reactions to sunlight or visible light (polymorphous light eruption, solar urticaria, persistent light reactivity)
- Pregnant or lactating or planning to become pregnant
- Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial
Ennek a vizsgálatnak nincs helyszíne itt: Egyesült Államok.
Egy országban van helyszíne. Válassz országot, hogy lásd a helyszíneket.
A vizsgálatról
Mit akar kideríteni a vizsgálat
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.
A teljes eredeti leírásKevesebb
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.
A vizsgálat 2 csoportja
- Active Neuro Rx DeviceMár használt kezelés, összehasonlításként
The active device will deliver light for the 20 minutes session duration.
Kezelés: Neuro RX Gamma device
- Sham Neuro Rx DeviceSzínlelt kezelés, összehasonlításként
The Sham device is indistinguishable from the active device. The sham device will not deliver light for the 20 minutes session duration.
Kezelés: Sham Neuro RX Gamma device
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- Hivatalos cím
- A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma for the Treatment of Amnestic Mild Cognitive Impairment (aMCI)
- A regiszteradat frissítve
- 2025. július 24.