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.
Who can participate
Age range50 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 inv…
What they're measuring
1
Change in the Severe Impairment Battery (SIB) score - An assessment of Severe Dementia in the elderly.