Clinical trial NCT03328195: Vielight Neuro RX Gamma - Feasibility Pilot
Official title: A Pilot Study Evaluating the Feasibility, Safety, and Efficacy of the Vielight Neuro RX Gamma Device for the Treatment of Moderate-to-severe Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alzheimer Disease
Lead sponsor: Vielight Inc.
Sponsor class: INDUSTRY
First posted: 2017-11-01
Enrollment: 60
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 RX Gamma is non-invasive and delivers near-infrared energy to the brain in daily treatment sessions at home. An optional substudy will involve the use of the Electroencephalogram (EEG) to assess the effect of the treatment devices on the electrical activity of the brain compared to sham.

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 undergo screening procedures to confirm eligibility to participate in the study, followed by randomization procedure to one of the study groups - treatment synchronized, treatment asynchronized or sham (placebo). A dedicated caregiver will apply the device to the subject for 20 minute daily sessions at home, 6 days a week for a total of 12 weeks. The subject and caregiver will be required to return to the clinic for follow-up assessments after 3, 6 and 12 weeks of treatment. Participants will have the choice of opting into a substudy involving the collection of rest EEG recordings during the baseline and weeks 3, 6 and 12 visits.

60 patients will be enrolled in 2 clinical sites in Ontario, Canada.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.
timeFrame: Baseline to Week 12
Secondary outcomes:
measure: Device safety according to the number of device-related adverse events
timeFrame: Baseline to Week 12
measure: Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
timeFrame: Baseline to Week 3
measure: Change in the Severe Impairment Battery score - An assessment of Severe Dementia in the elderly.
timeFrame: Baseline to Week 6
measure: Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
timeFrame: Baseline to Week 3
measure: Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
timeFrame: Baseline to Week 6
measure: Change in the Alzheimer's Disease Cooperative Study - Activities of Daily Living for Severe Alzheimer's Disease (ADL SAD) score
timeFrame: Baseline to Week 12
measure: Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
timeFrame: Baseline to Week 3
measure: Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
timeFrame: Baseline to Week 6
measure: Change in the Neuropsychiatric Inventory (NPI) score which assesses behavioral changes in neurologic illnesses based on a standardized caregiver interview.
timeFrame: Baseline to Week 12
measure: Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
timeFrame: Baseline to Week 3
measure: Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
timeFrame: Baseline to Week 6
measure: Change in the Alzheimer's Disease Cooperative Study - Clinical Global Impression of Change (ADCS CGIC) score.
timeFrame: Baseline to Week 12
measure: Change in the Electroencephalogram's (EEG) overall power spectral density
timeFrame: Baseline to Week 12
Other outcomes:
measure: Caregiver reported treatment compliance
timeFrame: 12 weeks
Locations:
city: Toronto
country: Canada
facility: Toronto Memory Program
state: Ontario
Study officials:
References: