Alzheimer DiseaseNCT03484143
Neuro RX Gamma - Pivotal Phase
A study testing Active Neuro RX Gamma device in people with Alzheimer Disease, run by Vielight Inc. at 9 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- Active Neuro RX Gamma device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 26 Jun 2019to May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- Mini-mental state examination (MMSE) score between 8-20.
- 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
- Age 50 and older at the time of enrolment.
- Severe Impairment Battery score at baseline ≤90
- Adequate caregiver to ensure compliance of home-based treatments and to complete study assessments and questionnaires.
Who cannot join
- 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:
- Detection of more than 2 subcortical lacunar infarcts
- Any hemorrhage or infarct in a strategic location, such as the anterior nuclei of the thalamus (including dorso-medial nucleus)
- Space-occupying lesions compressing or compromising brain structures. (Note small meningiomas not compressing brain areas may be allowed)
- 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.
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- History of significant agitation and/or aggression.
- History of stroke or 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.
- Current participation in another interventional clinical trial.
- Any reason that, in the opinion of the investigator, might place a participant at unacceptable risk for participation in the trial.
- Subject and/or caregiver does not speak English at a level necessary for the completion of the assessments.
Trial locations and contacts
9 sites in 2 countries.
9 sites in 2 countries
Canada8 sites
True North Clinical Research
Halifax, Nova Scotia, B3S 1N2
Okanagan Clinical Trials
Kelowna, British Columbia, V1Y 1Z9
Bruyère Research Institute
Ottawa, Ontario, K1R 6M1464
Ottawa Memory Clinic
Ottawa, Ontario, K1Z 1G3
Healthtech Connex /Fraser Health
Surrey, British Columbia, V3V 0C6
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
St. Michael's Hospital
Toronto, Ontario, M5B1W8
Baycrest
Toronto, Ontario, M6A 2E1
About this study
Official title: Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease
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.
Read the 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.
- Conditions
- Alzheimer Disease
- Being tested
- Active Neuro RX Gamma device, Sham Neuro RX Gamma device
- Keywords
- Moderate to Severe Alzheimer's Disease,
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active Neuro RX Gamma deviceDevice
Twenty minute treatment session, 6 days a week for 24 weeks
Sham Neuro RX Gamma deviceDevice
Twenty minute treatment session, 6 days a week for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Neuro RX Gamma device | Active comparator | Neuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally Receives: Device: Active Neuro RX Gamma device |
| Sham Neuro RX Gamma device | Sham comparator | 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 Receives: Device: Sham Neuro RX Gamma device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline to Week 24
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: Baseline to Week 12 and Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2018
- Study start26 Jun 2019
- Primary completionMay 2023 (estimated)
- Study completionMay 2023 (estimated)
Why it stopped: Recruitment has been too slow. We are considering some changes to the protocol.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vielight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Corinne Fischer, MD, Principal investigator, Unity Health Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03484143
- Sponsor's protocol ID
- P17.03
- Status last verified
- Jan 2023
- First submitted
- 23 Mar 2018
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03484143
- Acronym / sponsor ID
- P17.03
- Conditions
- Alzheimer Disease
- Keywords
- Moderate to Severe Alzheimer's Disease,
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Recruitment has been too slow. We are considering some changes to the protocol.
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Vielight Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- May 2023 (estimated)
- First posted
- 30 Mar 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Neuro RX Gamma device | Active comparator | Device: Active Neuro RX Gamma deviceNeuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally |
| Sham Neuro RX Gamma device | Sham comparator | Device: Sham Neuro RX Gamma deviceSham 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 |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
- Mini-mental state examination (MMSE) score between 8-20.
- 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
- Age 50 and older at the time of enrolment.
- Severe Impairment Battery score at baseline ≤90
Key exclusion criteria (17 listed)
- 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.
- History of significant agitation and/or aggression.
- History of stroke or epileptic seizures.
- Current neurologic disease affecting cognition other than Alzheimer's disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Active Neuro RX Gamma deviceTwenty minute treatment session, 6 days a week for 24 weeks | Device | Active Neuro RX Gamma device |
| Sham Neuro RX Gamma deviceTwenty minute treatment session, 6 days a week for 24 weeks | Device | Sham Neuro RX Gamma device |
Primary outcome
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.
5 secondary outcomes
Change in Severe Impairment Battery (SIB) score
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)
Time frame: Baseline to Week 12
Change in European Quality of Life Scale (EQ-5 dimensions [5D], proxy version)
Time frame: Baseline to Week 12 and Baseline to Week 24
Change in Quality of Life in Alzheimer's Disease (QOL-AD)
Time frame: Baseline to Week 12 and Baseline to Week 24
Change in Neuropsychiatric Inventory Questionnaire (NPI) - including Caregiver Distress ratings
Time frame: Baseline to Week 12 and Baseline to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corinne Fischer, MD principal investigator
Unity Health Toronto
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Neuro RX Gamma device in people with Alzheimer Disease, run by Vielight Inc. at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Canada, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Severe Impairment Battery (SIB) score (time frame: Baseline to Week 24). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.