Back to resultsNeuro RX Gamma - Pivotal Phase
Primary Purpose
Alzheimer Disease
Status
Suspended
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Active Neuro RX Gamma device
Sham Neuro RX Gamma device
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Moderate to Severe Alzheimer's Disease,
Eligibility Criteria
Inclusion Criteria:
- 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.
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:
- 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.
- 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.
Sites / Locations
- Headlands Research Orlando
- Okanagan Clinical Trials
- Healthtech Connex /Fraser Health
- True North Clinical Research
- Bruyère Research Institute
- Ottawa Memory Clinic
- Sunnybrook Research Institute
- St. Michael's Hospital
- Baycrest
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Active Neuro RX Gamma device
Sham Neuro RX Gamma device
Arm Description
Neuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally
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
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03484143
Brief Title
Neuro RX Gamma - Pivotal Phase
Official Title
Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Suspended
Why Stopped
Recruitment has been too slow. We are considering some changes to the protocol.
Study Start Date
June 26, 2019 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vielight Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Moderate to Severe Alzheimer's Disease,
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
228 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Active Neuro RX Gamma device
Arm Type
Active Comparator
Arm Description
Neuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally
Arm Title
Sham Neuro RX Gamma device
Arm Type
Sham Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Active Neuro RX Gamma device
Intervention Description
Twenty minute treatment session, 6 days a week for 24 weeks
Intervention Type
Device
Intervention Name(s)
Sham Neuro RX Gamma device
Intervention Description
Twenty minute treatment session, 6 days a week for 24 weeks
Primary Outcome Measure Information:
Title
Change in Severe Impairment Battery (SIB) score
Description
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
Title
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev)
Description
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
Secondary Outcome Measure Information:
Title
Change in Severe Impairment Battery (SIB) score
Description
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
Title
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev)
Description
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
Title
Change in European Quality of Life Scale (EQ-5 dimensions [5D], proxy version)
Description
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
Title
Change in Quality of Life in Alzheimer's Disease (QOL-AD)
Description
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
Title
Change in Neuropsychiatric Inventory Questionnaire (NPI) - including Caregiver Distress ratings
Description
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
Other Pre-specified Outcome Measures:
Title
Device related Adverse Events
Description
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
Title
Rates of epistaxis in aspirin/anti-coagulant users
Description
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
Title
Rates of nasal infection
Description
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
Title
Rates of device/treatment anxiety
Description
The rates of device/treatment anxiety as assessed by the Neuropsychiatric Inventory Questionnaire - Anxiety subdomain
Time Frame
Baseline to Week 24
Title
Rates of device/treatment anxiety
Description
The rates of device/treatment anxiety as assessed by the Zarit Caregiver Burden Interview
Time Frame
Baseline to Week 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
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:
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.
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne Fischer, MD
Organizational Affiliation
Unity Health Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Headlands Research Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Okanagan Clinical Trials
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 1Z9
Country
Canada
Facility Name
Healthtech Connex /Fraser Health
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 0C6
Country
Canada
Facility Name
True North Clinical Research
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3S 1N2
Country
Canada
Facility Name
Bruyère Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1R 6M1464
Country
Canada
Facility Name
Ottawa Memory Clinic
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Z 1G3
Country
Canada
Facility Name
Sunnybrook Research Institute
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
St. Michael's Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B1W8
Country
Canada
Facility Name
Baycrest
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A 2E1
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Neuro RX Gamma - Pivotal Phase
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