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

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.