Status:
SUSPENDED
Neuro RX Gamma - Pivotal Phase
Lead Sponsor:
Vielight Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
NA
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 seve...
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 t...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2023
Estimated Enrollment :
228 Patients enrolled
Trial Details
Trial ID
NCT03484143
Start Date
June 26 2019
End Date
May 1 2023
Last Update
January 25 2023
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Headlands Research Orlando
Orlando, Florida, United States, 32819
2
Okanagan Clinical Trials
Kelowna, British Columbia, Canada, V1Y 1Z9
3
Healthtech Connex /Fraser Health
Surrey, British Columbia, Canada, V3V 0C6
4
True North Clinical Research
Halifax, Nova Scotia, Canada, B3S 1N2