An interventional study of Active Neuro RX Gamma device and Sham Neuro RX Gamma device in Alzheimer Disease, sponsored by Vielight Inc.. Suspended at 9 sites in 2 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2023-01-25.
Sponsored by Vielight Inc. · Not applicable, Interventional, and Treatment
The active Neuro RX Gamma device uses non-invasive near-infrared energy delivered to the brain with the intention to improve cognitive functioning and quality of life in patients with moderate to severe Alzheimer's Disease. Treatment will occur at home-based treatment sessions with the device.
A potential participant will undergo pre-screening and screening assessments to assess eligibility for the study. Eligible participants will undergo a baseline visit in which they will be randomized to either active or sham Neuro RX Gamma device.
The Vielight Neuro RX Gamma is a non-invasive device that administers low-energy near-infrared LED (light emitting diode) light to the brain transcranially and intranasally.
There are two treatment phases in the trial, each with a duration of 12 weeks. The patient along with the caregiver will perform home (or living facility) - based treatments with the device and document the sessions in a patient diary. The device will be applied to the patient participant by a dedicated caregiver for a 20 minute daily session, 6 days a week for a total of 12 weeks. The study participant and caregiver will be required to return to the clinic for follow-up assessments at 12 and 24 weeks post randomization, between treatment phases.
228 patients will be enrolled across 12 sites in Canada and the United States.
Exclusion Criteria:
Evidence of a relevant abnormality other than Alzheimer's disease on MRI or CT scan obtained within previous 24 months of enrolment into the trial, as listed below:
Any patient without a scan in the past 2 years should undergo an MRI or CT as part of the study's screening assessment.
Neuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally
Device: Active Neuro RX Gamma device
Sham Neuro RX Gamma device is identical in appearance and sound as the active Neuro RX Gamma device but does not emit low-energy near infrared light
Device: Sham Neuro RX Gamma device
Twenty minute treatment session, 6 days a week for 24 weeks
Twenty minute treatment session, 6 days a week for 24 weeks
Change in Severe Impairment Battery (SIB) score
The SIB assesses cognitive abilities in severely impaired individuals. The scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items with a total score range from 0-100. Scores of less than 63 on the SIB are rated as very severely impaired.
Time frame: Baseline to Week 24
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev)
The ADCS-ADL-Sev assesses the ability of patients with moderate to severe dementia to perform activities of daily living. There are 19 items with a total score range of 0-54.
Time frame: Baseline to Week 24
Change in Severe Impairment Battery (SIB) score
The SIB assesses cognitive abilities in severely impaired individuals. The scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items with a total score range from 0-100. Scores of less than 63 on the SIB are rated as very severely impaired.
Time frame: Baseline to Week 12
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev)
The ADCS-ADL-Sev assesses the ability of patients with moderate to severe dementia to perform activities of daily living. There are 19 items with a total score range of 0-54.
Time frame: Baseline to Week 12
Change in European Quality of Life Scale (EQ-5 dimensions [5D], proxy version)
The EQ-5D is a standardized instrument for use as a measure of health outcomes. It includes measures of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. The EQ visual analogue scale (VAS) records the respondent's self-rated health on a 20 cm vertical, visual analogue scale with endpoints labelled 'the best health you can imagine' and 'the worst health you can imagine'. This information can be used as a quantitative measure of health as judged by the individual respondents.
Time frame: Baseline to Week 12 and Baseline to Week 24
Change in Quality of Life in Alzheimer's Disease (QOL-AD)
The QOL-AD is a series of questions designed to be administered to individuals with dementia, to obtain a rating of a patient's quality of life from both the patient and the caregiver. It includes assessments of the individual's relationship with friends and family, concerns about finances, physical condition, mood, and an overall assessment of life quality. There are 13 items with a score range from 13 to 52.
Time frame: Baseline to Week 12 and Baseline to Week 24
Change in Neuropsychiatric Inventory Questionnaire (NPI) - including Caregiver Distress ratings
The NPI assesses neuropsychiatric symptoms during routine clinical settings. Namely, the frequency, severity and level of distress caused by 12 common dementia-related behaviors (delusions, hallucinations, agitation/aggression, depression/dysphoria, anxiety, elation/euphoria, apathy/indifference, disinhibition, irritability/lability, aberrant motor behavior, sleep and appetite/eating disorders).
Time frame: Baseline to Week 12 and Baseline to Week 24
Device related Adverse Events
Device safety assessed according to number of device-related adverse events throughout the course of the study
Time frame: Baseline to Week 12 and Baseline to Week 24
Rates of epistaxis in aspirin/anti-coagulant users
The rates of epistaxis in aspirin/anti-coagulant users will be recorded at each study visit and compared to that reported (at baseline) by the subject/caregiver during the prior 24 week period.
Time frame: Baseline to Week 24 compared to 24 weeks prior to study intervention
Rates of nasal infection
The rates of nasal infection will be recorded at each study visit and compared to that reported (at baseline) by the subject during the prior 24 week period.
Time frame: Baseline to Week 24 compared to 24 weeks prior to study intervention
Rates of device/treatment anxiety
The rates of device/treatment anxiety as assessed by the Neuropsychiatric Inventory Questionnaire - Anxiety subdomain
Time frame: Baseline to Week 24
Rates of device/treatment anxiety
The rates of device/treatment anxiety as assessed by the Zarit Caregiver Burden Interview
Time frame: Baseline to Week 24
Plan to share: No
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Vielight Inc.