Examining the Impact of Photobiomodulation on Cognition, Behavior, and Biomarkers of Alzheimer’s Disease
Sponsor:
Brief Summary:
the eye) to heal and protect tissue that has either been injured, is degenerating, or else is
at risk of dying. Research suggests that the light delivered during PBM enhances the body’s
biochemical ability to store and use energy and increase blood flow, which triggers the
body’s natural healing processes. The goal of this study is to determine if PBM administered
transcranially (through the scalp and skull) and intranasally (inside the nose) has an effect
on cognitive function and behavioral symptoms in people with Alzheimer’s disease (AD). The
study will also examine whether PBM has an effect on biomarkers of AD in the blood and spinal
fluid of patients with AD. A biomarker is a specific physical trait used to measure the
progress of a disease or condition.
Criteria
– Diagnosis of AD supported by AD biomarkers (CSF or amyloid PET)
– Mini-Mental State Exam (MMSE) score > 13
– fluent in English
– has a reliable caregiver/study partner who can help administer and log PBM use
– no history of stroke or seizures
– willing to undergo 2 lumbar punctures approximately 4 months apart
– legally authorized representative consent
Exclusion Criteria: (for participants with AD)
– lack of assent to study procedures
– terminal illness (i.e., life expectancy < 1 year) - started dementia medication (i.e., cholinesterase inhibitor or memantine) within the past 3 months or planning to start new dementia medication - current participation in another research study that could potentially confound current study (e.g., medication or behavioral intervention) - MMSE < 13 - history of structural brain lesions or stroke temporally related to the onset or worsening of cognitive impairment - history of head trauma associated with injury-onset cognitive complaints or loss of consciousness for 10 minutes or longer. Inclusion Criteria (for study partners): - ability to answer questions about the primary participant's memory, behaviors, and activities of daily living - willingness to help primary participant use and log the use of the Vielight Neuro Gamma device every other day for 16 weeks - fluent in English Exclusion Criteria (for study partners): - major neurological or psychiatric condition - terminal illness (i.e., life expectancy < 1 year) - evidence of cognitive impairment - inability to consent to study procedure
Locations
- VA Health Care System, San Francisco, California, United States, 94121
- UCSF Memory and Aging Center, San Francisco, California, United States, 94158