Stopped: Recruitment has been too slow. We are considering some changes to the protocol.
United States, Canada228 participantsStarted 2019-06-26
Plain-language 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.
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
✓. 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.
Exclusion criteria
✕. 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.)
What they're measuring
1
Change in Severe Impairment Battery (SIB) score
Timeframe: Baseline to Week 24
2
Change in Alzheimer's Disease Cooperative Study Activities of Daily Living for Severe Alzheimer's Disease (ADCS-ADL-Sev)