Neuro RX Gamma - Pivotal Phase

• ClinicalTrials.gov Identifier: NCT03484143
• Recruitment Status: Suspended
• First Posted: March 30, 2018
• Last Update Posted: January 25, 2023
• Sponsor: Vielight Inc.
• Information provided by (Responsible Party): Vielight Inc.

Tracking Information

• First Submitted Date: March 23, 2018
• First Posted Date: March 30, 2018
• Last Update Posted Date: January 25, 2023
• Actual Study Start Date: June 26, 2019
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 24, 2019)

• Change in Severe Impairment Battery (SIB) score [ Time Frame: Baseline to Week 24 ]
  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.
• Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev) [ Time Frame: Baseline to Week 24 ]
  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.

Original Primary Outcome Measures (submitted: March 29, 2018)

• Change in Severe Impairment Battery (SIB) score [ Time Frame: Baseline to Week 24 ]
  The SIB assesses cognitive abilities in severely impaired individuals. The scale covers social interaction, memory, orientation, language, attention, praxis, visuospacial 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.
• Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev) [ Time Frame: Baseline to Week 24 ]
  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.

Current Secondary Outcome Measures (submitted: May 12, 2021)

• Change in Severe Impairment Battery (SIB) score [ Time Frame: Baseline to Week 12 ]
  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.
• Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev) [ Time Frame: Baseline to Week 12 ]
  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.
• Change in European Quality of Life Scale (EQ-5 dimensions [5D], proxy version) [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  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.
• Change in Quality of Life in Alzheimer's Disease (QOL-AD) [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  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.
• Change in Neuropsychiatric Inventory Questionnaire (NPI) - including Caregiver Distress ratings [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  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).

Original Secondary Outcome Measures (submitted: March 29, 2018)

• Change in Severe Impairment Battery (SIB) score [ Time Frame: Baseline to Week 12 ]
  The SIB assesses cognitive abilities in severely impaired individuals. The scale covers social interaction, memory, orientation, language, attention, praxis, visuospacial 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.
• Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev) [ Time Frame: Baseline to Week 12 ]
  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.
• Change in European Quality of Life Scale (EQ-5D, proxy version) [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  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 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.
• Change in Quality of Life in Alzheimer's Disease (QOL-AD) [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  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.
• Change in Neuropsychiatric Inventory Questionnaire (NPI) - including Caregiver Distress ratings [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  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).
• Change in Resource Utilization in Dementia (RUD) [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  The RUD estimates the amount of informal care provided by caregivers to dementia patients. It is based on caregiver recall.

Current Other Pre-specified Outcome Measures (submitted: April 24, 2019)

• Device related Adverse Events [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  Device safety assessed according to number of device-related adverse events throughout the course of the study
• Rates of epistaxis in aspirin/anti-coagulant users [ Time Frame: Baseline to Week 24 compared to 24 weeks prior to study intervention ]
  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.
• Rates of nasal infection [ Time Frame: Baseline to Week 24 compared to 24 weeks prior to study intervention ]
  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.
• Rates of device/treatment anxiety [ Time Frame: Baseline to Week 24 ]
  The rates of device/treatment anxiety as assessed by the Neuropsychiatric Inventory Questionnaire - Anxiety subdomain
• Rates of device/treatment anxiety [ Time Frame: Baseline to Week 24 ]
  The rates of device/treatment anxiety as assessed by the Zarit Caregiver Burden Interview

Original Other Pre-specified Outcome Measures (submitted: March 29, 2018)

• Device related Adverse Events [ Time Frame: Baseline to Week 12 and Baseline to Week 24 ]
  Device safety assessed according to number of device-related adverse events throughout the course of the study
• Rates of epistaxis in aspirin/anti-coagulant users [ Time Frame: Baseline to Week 24 compared to 24 weeks prior to study intervention ]
  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.
• Rates of nasal infection [ Time Frame: Baseline to Week 24 compared to 24 weeks prior to study intervention ]
  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.

Descriptive Information

• Brief Title: Neuro RX Gamma - Pivotal Phase
• Official Title: Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease
• Brief Summary: 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.

Detailed Description

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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Alzheimer Disease

Intervention

• Device: Active Neuro RX Gamma device
  Twenty minute treatment session, 6 days a week for 24 weeks
• Device: Sham Neuro RX Gamma device
  Twenty minute treatment session, 6 days a week for 24 weeks

Study Arms

• Active Comparator: Active Neuro RX Gamma device
  Neuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally
  Intervention: Device: Active Neuro RX Gamma device
• Sham Comparator: Sham 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
  Intervention: Device: Sham Neuro RX Gamma device

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Suspended
• Estimated Enrollment (submitted: March 29, 2018): 228
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2023
• Estimated Primary Completion Date: May 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Diagnosis of AD, defined as probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association.
2. Mini-mental state examination (MMSE) score between 8-20.
3. If receiving AD/psychotropic medication, must be on a stable dosage for at least 12 weeks prior to trial enrolment with no anticipated changes for the duration of the trial
4. Age 50 and older at the time of enrolment.
5. Severe Impairment Battery score at baseline ≤90
6. Adequate caregiver to ensure compliance of home-based treatments and to complete study assessments and questionnaires.

Exclusion Criteria:

1. 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:

   1. Detection of more than 2 subcortical lacunar infarcts
   2. Any hemorrhage or infarct in a strategic location, such as the anterior nuclei of the thalamus (including dorso-medial nucleus)
   3. Space-occupying lesions compressing or compromising brain structures. (Note small meningiomas not compressing brain areas may be allowed)
   4. Patients with imaging findings that in the opinion of the investigator could be contributing to cognitive impairment (such as major cortical strokes, extensive white matter disease, etc.)

   Any patient without a scan in the past 2 years should undergo an MRI or CT as part of the study's screening assessment.

2. History of significant agitation and/or aggression.
3. History of stroke or epileptic seizures.
4. Current neurologic disease affecting cognition other than Alzheimer's disease.
5. Photosensitivity reactions to sunlight or visible light (polymorphous light eruption, solar urticaria, persistent light reactivity).
6. History of recurrent epistaxis within the last 24 weeks or currently taking major anti-coagulants (including warfarin, low molecular weight heparin)
7. 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.
8. Pregnant or lactating or planning to become pregnant.
9. Currently undergoing light therapy treatment.
10. Current participation in another interventional clinical trial.
11. Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial.
12. Subject and/or caregiver does not speak English at a level necessary for the completion of the assessments.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT03484143
• Other Study ID Numbers: P17.03
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Vielight Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Vielight Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Corinne Fischer, MD; Unity Health Toronto

• PRS Account: Vielight Inc.
• Verification Date: January 2023