Vielight Neuro RX Gamma Photobiomodulation Device for Moderate to Severe Alzheimer's Disease

  • STATUS
    Recruiting
  • participants needed
    228
  • sponsor
    Vielight Inc.
Updated on 30 July 2021
Investigator
Gabriela Pawlowski
Primary Contact
Fraser Health Authority & Healthtech Connex (3.6 mi away) Contact
+8 other location
stroke
mini-mental state examination
mental state examination

Summary

The active Neuro RX Gamma device uses non-invasive near-infrared energy delivered to the brain transcranially and intranasally 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.

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.

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. 

228 patients will be enrolled across 12 sites in Canada and the United States.

Description


Details
Condition Alzheimer's Disease
Clinical Study IdentifierTX278681
SponsorVielight Inc.
Last Modified on30 July 2021

Eligibility

Yes No Not Sure

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
a) Detection of more than 2 subcortical lacunar infarcts
b) Any hemorrhage or infarct in a strategic location, such as the anterior nuclei of the thalamus (including dorso-medial nucleus)
c) Space-occupying lesions compressing or compromising brain structures. (Note small meningiomas not compressing brain areas may be allowed)
d) 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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