Alzheimer DiseaseNCT03328195
Vielight Neuro RX Gamma - Feasibility Pilot
A study testing Neuro RX Gamma synchronous and Neuro RX Gamma asynchronous in people with Alzheimer Disease, run by Vielight Inc. at 1 site in Canada.
Trial summary
This study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. 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?
- Neuro RX Gamma synchronous and Neuro RX Gamma asynchronous
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 4 Dec 2017to 28 Feb 2022
- 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
- Age is greater than or equal to 50 years old
- Meets the criteria for probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months
- Mini Mental State Examination (MMSE) score between 0-20 at screening assessment
- Severe Impairment Battery score at baseline of ≤90
- Outpatient with a reliable caregiver willing to commit to study visits and procedures
Who cannot join
- Current psychiatric or other neurologic disease
- Any history of stroke, seizures, light sensitivity (polymorphous light eruption, solar urticaria, persistent light reactivity) or Lyme disease, including those taking photosensitizing medication
- Currently undergoing light therapy treatment
- 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
- Any issues with ambulation, vision, or hearing which could, in the opinion of the investigator, interfere with their ability to complete assessments
Show all 10Show fewer
- Does not speak English at a level necessary for the completion of the assessments.
- Currently participating in another clinical research study involving an investigational product.
- Has participated in a drug or device study within the last 30 days.
- Any condition, such as agitation/aggression, that in the opinion of the investigator would cause the patient to be unable to comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma Device for the Treatment of Moderate-to-severe Alzheimer's Disease
This study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.
Read the detailed description
The Neuro RX Gamma system is a headset which emits pulsed near-infrared energy synchronously or asynchronously through diodes placed on the scalp and inside a nostril.
A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment synchronized, treatment asynchronized or sham (placebo). A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. Participants will have the choice of opting into a substudy involving the collection of rest EEG recordings during the baseline and weeks 3, 6 and 12 visits.
60 patients will be enrolled in 2 clinical sites in Ontario, Canada.
- Conditions
- Alzheimer Disease
- Being tested
- Neuro RX Gamma synchronous, Sham, Neuro RX Gamma asynchronous
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuro RX Gamma synchronousDevice
Twenty minute treatment, six days per week for 12 weeks
ShamDevice
Twenty minutes, six days per week for 12 weeks with sham device
Neuro RX Gamma asynchronousDevice
Twenty minutes, six days per week for 12 weeks with sham device
| Study group | Role | What they receive |
|---|---|---|
| Neuro RX Gamma synchronous | Active comparator | Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril.The synchronous device delivers a synchronized pulse frequency of 40 Hz from all LED clusters. Receives: Device: Neuro RX Gamma synchronous |
| Sham light therapy | Sham comparator | Sham Neuro RX Gamma device having the same appearance and sound as the Neuro RX Gamma device but does not emit the near-infrared light. Receives: Device: Sham |
| Neuro RX Gamma asynchronous | Active comparator | Neuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril. The asynchronous device alternatively delivers pulses from the intranasal and anterior LEDs vs. from the posterior LEDS. Receives: Device: Neuro RX Gamma asynchronous |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Measured: Baseline to Week 12
Secondary outcomes (13)
Device safety according to the number of device-related adverse events
Subjects will be monitored for clinical evidence of device-related adverse events throughout the study.
Measured: Baseline to Week 12
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Measured: Baseline to Week 3
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
Measured: Baseline to Week 6
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Measured: Baseline to Week 3
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Measured: Baseline to Week 6
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
The ADL SAD assesses the performance of activities of daily living by patients with Alzheimer's disease. The assessment includes 19 questions. The score for each question ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13; questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. Subscales will be summed to compute the total score. The total score ranges from 0 - 54 with higher scores indicating less functional impairment and greater competence.
Measured: Baseline to Week 12
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
The NPI assesses 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).
Measured: Baseline to Week 3
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
The NPI assesses 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).
Measured: Baseline to Week 6
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
The NPI assesses 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).
Measured: Baseline to Week 12
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Measured: Baseline to Week 3
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Measured: Baseline to Week 6
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
The ADCS CGIC gives the Clinician's assessment of the patient's response to the treatment. It is intended to be used as a measure of clinically meaningful change. The ADCS-CGIC focuses on clinicians' observations of change in the patient's cognitive, functional, and behavioral performance since the beginning of a trial. It relies on both direct examination of the patient and interview of the caregiver. Scored as marked/moderate/minimal improvement or worsening or no change.
Measured: Baseline to Week 12
Change in the Electroencephalogram's (EEG) overall power spectral density
The EEG recordings will give insight into the effect on the neural activity of the brain of the Neuro RX Gamma synchronized and Neuro RX Gamma asynchronized compared to sham.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2017
- Study start4 Dec 2017
- Primary completion12 Nov 2021
- Study completion28 Feb 2022
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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vielight Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03328195
- Sponsor's protocol ID
- P17.02
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2017
- Last updated
- 25 Jan 2023
- Results posted
- 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
- A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma Device for the Treatment of Moderate-to-severe Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03328195
- Acronym / sponsor ID
- P17.02
- Conditions
- Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Vielight Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Dec 2017 (actual)
- Primary completion
- 12 Nov 2021 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 1 Nov 2017 (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.
This study tests the effects of the Neuro RX Gamma synchronous and asynchronous devices on the cognitive and behavioral functioning of subjects with moderate-to-severe Alzheimer's Disease. The Neuro RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.
Detailed description
The Neuro RX Gamma system is a headset which emits pulsed near-infrared energy synchronously or asynchronously through diodes placed on the scalp and inside a nostril.
A potential participant will undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment synchronized, treatment asynchronized or sham (placebo). A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. Participants will have the choice of opting into a substudy involving the collection of rest EEG recordings during the baseline and weeks 3, 6 and 12 visits.
60 patients will be enrolled in 2 clinical sites in Ontario, Canada.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neuro RX Gamma synchronous | Active comparator | Device: Neuro RX Gamma synchronousNeuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril.The synchronous device delivers a synchronized pulse frequency of 40 Hz from all LED clusters. |
| Sham light therapy | Sham comparator | Device: ShamSham Neuro RX Gamma device having the same appearance and sound as the Neuro RX Gamma device but does not emit the near-infrared light. |
| Neuro RX Gamma asynchronous | Active comparator | Device: Neuro RX Gamma asynchronousNeuro RX Gamma device delivering near infra-red light through four diodes positioned over the scalp and one positioned inside the nostril. The asynchronous device alternatively delivers pulses from the intranasal and anterior LEDs vs. from the posterior LEDS. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age is greater than or equal to 50 years old
- Meets the criteria for probable Alzheimer's disease of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA)
- If receiving ongoing cholinesterase inhibitor therapy and/or memantine, must be on a stable dosage for at least the prior 3 months
- Mini Mental State Examination (MMSE) score between 0-20 at screening assessment
- Severe Impairment Battery score at baseline of ≤90
Key exclusion criteria (10 listed)
- Current psychiatric or other neurologic disease
- Any history of stroke, seizures, light sensitivity (polymorphous light eruption, solar urticaria, persistent light reactivity) or Lyme disease, including those taking photosensitizing medication
- Currently undergoing light therapy treatment
- 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
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 |
|---|---|---|
| Neuro RX Gamma synchronousTwenty minute treatment, six days per week for 12 weeks | Device | Neuro RX Gamma synchronous |
| ShamTwenty minutes, six days per week for 12 weeks with sham device | Device | Sham light therapy |
| Neuro RX Gamma asynchronousTwenty minutes, six days per week for 12 weeks with sham device | Device | Neuro RX Gamma asynchronous |
Primary outcome
Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.
Time frame: Baseline to Week 12
The SIB evaluates cognitive abilities in severely impaired individuals. This scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items and the SIB score ranges from 0-100. Individuals who score less than 63 on the SIB are rated as very severely impaired.
13 secondary outcomes
Device safety according to the number of device-related adverse events
Time frame: Baseline to Week 12
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
Time frame: Baseline to Week 3
Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
Time frame: Baseline to Week 6
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
Time frame: Baseline to Week 3
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
Time frame: Baseline to Week 6
Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
Time frame: Baseline to Week 12
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
Time frame: Baseline to Week 3
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
Time frame: Baseline to Week 6
Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
Time frame: Baseline to Week 12
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
Time frame: Baseline to Week 3
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
Time frame: Baseline to Week 6
Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
Time frame: Baseline to Week 12
Change in the Electroencephalogram's (EEG) overall power spectral density
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuro RX Gamma synchronous and Neuro RX Gamma asynchronous in people with Alzheimer Disease, run by Vielight Inc. at 1 site in Canada.
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 10 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: finished, 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 1 site in Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly. (time frame: Baseline to Week 12). 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.