Status:
COMPLETED
Vielight Neuro RX Gamma - Feasibility Pilot
Lead Sponsor:
Vielight Inc.
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief 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 R...
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 un...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT03328195
Start Date
December 4 2017
End Date
February 28 2022
Last Update
January 25 2023
Active Locations (1)
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1
Toronto Memory Program
Toronto, Ontario, Canada, M3B2S7