Neuro RX Gamma - Pivotal Phase

NCT03484143 | Suspended

• 1 other identifier: P17.03
• Study Type: interventional
• Target: 228
• Locations: 2 countries
• Sites: 9

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 severe Alzheimer's Disease. Treatment will occur at home-based treatment sessions with the device.

Conditions

Alzheimer Disease

Keywords

Moderate to Severe Alzheimer's Disease,

Outcome Measures

Primary Outcomes (2)

• Change in Severe Impairment Battery (SIB) score

  The SIB assesses cognitive abilities in severely impaired individuals. The scale covers social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction and orientation to name. There are 40 items with a total score range from 0-100. Scores of less than 63 on the SIB are rated as very severely impaired.

  Baseline to Week 24

• Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev)

  The ADCS-ADL-Sev assesses the ability of patients with moderate to severe dementia to perform activities of daily living. There are 19 items with a total score range of 0-54.

  Baseline to Week 24

Secondary Outcomes (5)

• Change in Severe Impairment Battery (SIB) score

  Baseline to Week 12

• Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev)

  Baseline to Week 12

• Change in European Quality of Life Scale (EQ-5 dimensions [5D], proxy version)

  Baseline to Week 12 and Baseline to Week 24

• Change in Quality of Life in Alzheimer's Disease (QOL-AD)

  Baseline to Week 12 and Baseline to Week 24

• Change in Neuropsychiatric Inventory Questionnaire (NPI) - including Caregiver Distress ratings

  Baseline to Week 12 and Baseline to Week 24

Other Outcomes (5)

• Device related Adverse Events

  Baseline to Week 12 and Baseline to Week 24

• Rates of epistaxis in aspirin/anti-coagulant users

  Baseline to Week 24 compared to 24 weeks prior to study intervention

• Rates of nasal infection

  Baseline to Week 24 compared to 24 weeks prior to study intervention

Study Arms (2)

Active Neuro RX Gamma device

ACTIVE COMPARATOR

Neuro RX Gamma device delivers low-energy near-infrared light, through 5 diodes, to the brain transcranially and intranasally

Device: Active Neuro RX Gamma device

Sham Neuro RX Gamma device

SHAM COMPARATOR

Sham Neuro RX Gamma device is identical in appearance and sound as the active Neuro RX Gamma device but does not emit low-energy near infrared light

Device: Sham Neuro RX Gamma device

Interventions

Active Neuro RX Gamma device DEVICE

Twenty minute treatment session, 6 days a week for 24 weeks

Active Neuro RX Gamma device

Sham Neuro RX Gamma device DEVICE

Twenty minute treatment session, 6 days a week for 24 weeks

Sham Neuro RX Gamma device

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vielight Inc.: lead

Study Sites (9)

Headlands Research Orlando

Orlando, Florida, 32819, United States

Location

Okanagan Clinical Trials

Kelowna, British Columbia, V1Y 1Z9, Canada

Location

Healthtech Connex /Fraser Health

Surrey, British Columbia, V3V 0C6, Canada

Location

True North Clinical Research

Halifax, Nova Scotia, B3S 1N2, Canada

Location

Bruyère Research Institute

Ottawa, Ontario, K1R 6M1464, Canada

Location

Ottawa Memory Clinic

Ottawa, Ontario, K1Z 1G3, Canada

Location

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B1W8, Canada

Location

Baycrest

Toronto, Ontario, M6A 2E1, Canada

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Corinne Fischer, MD

  Unity Health Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2018
• First Posted: March 30, 2018
• Study Start: June 26, 2019
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: January 25, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); CA (8)