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Neuro RX Gamma - Pivotal Phase

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ClinicalTrials.gov Identifier: NCT03484143
Recruitment Status : Not yet recruiting
First Posted : March 30, 2018
Last Update Posted : October 12, 2018
Sponsor:
Information provided by (Responsible Party):
Vielight Inc.

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Device: Active Neuro RX Gamma device Device: Sham Neuro RX Gamma device Not Applicable

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 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 8 sites in Canada and the United States.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 228 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease
Estimated Study Start Date : January 2019
Estimated Primary Completion Date : January 2021
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Device: Active Neuro RX Gamma device
Twenty minute treatment session, 6 days a week for 24 weeks

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




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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).

  6. 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.


Other Outcome Measures:
  1. 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

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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. Stable dosage of AD medication for 24 weeks prior to trial enrolment with no changes anticipated for the duration of the trial.
  4. Age 50 and older at the time of enrolment.

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. Single hemorrhage or infarct with longest diameter of more than 1.5 cm irrespective of the location
    2. Detection of 2 or more subcortical lacunar infarcts of less than 1.5 cm in diameter (small cortical infarcts of less than 1.5 cm in diameter are acceptable)
    3. Any hemorrhage or infarct in the anterior nuclei of the thalamus (including dorso-medial nucleus)
    4. Space-occupying lesions compressing or compromising brain structures. (Note small meningiomas not compressing brain areas may be allowed)

    If any hemorrhage or infarct is detected on an MRI or CT scan older than 1 year, and the hemorrhage or infarct does not per se lead to exclusion of the patient, an MRI or CT scan has to be repeated before definite inclusion.

  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) or requiring photosensitizing medication.
  6. History of epistaxis or currently taking major anti-coagulants, such as warfarin.
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484143


Contacts
Contact: Janine Liburd 1-888-730-3805 clinicalstudies@vielight.com

Locations
Canada, Ontario
St. Michael's Hospital Not yet recruiting
Toronto, Ontario, Canada, M5B1W8
Contact: Corinne Fischer, MD       fischerc@smh.ca   
Sponsors and Collaborators
Vielight Inc.

Responsible Party: Vielight Inc.
ClinicalTrials.gov Identifier: NCT03484143     History of Changes
Other Study ID Numbers: P17.03
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by Vielight Inc.:
Moderate to Severe Alzheimer's Disease,

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders