Neuro RX Gamma - Pivotal Phase

Paused · Not applicable · Has a placebo group

Conditions studied: Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT03484143

Run by

Vielight Inc.

People needed

228

Starts

2019-06-26

Expected to finish

2023-05-01

Last updated by the study team

2023-01-25

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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.
• 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.

Where it is running

• Headlands Research Orlando — Orlando, Florida, United States
• Okanagan Clinical Trials — Kelowna, British Columbia, Canada
• Healthtech Connex /Fraser Health — Surrey, British Columbia, Canada
• True North Clinical Research — Halifax, Nova Scotia, Canada
• Bruyère Research Institute — Ottawa, Ontario, Canada
• Ottawa Memory Clinic — Ottawa, Ontario, Canada
• Sunnybrook Research Institute — Toronto, Ontario, Canada
• St. Michael's Hospital — Toronto, Ontario, Canada
• Baycrest — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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