Status:
COMPLETED
Impact of Photobiomodulation (PBM) on Biomarkers of Alzheimer's Disease
Lead Sponsor:
University of California, San Francisco
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Photobiomodulation (PBM) describes the use of near-infrared light (which is not visible to the eye) to heal and protect tissue that has either been injured, is degenerating, or else is at risk of dyin...
Detailed Description
Alzheimer's disease (AD), the most common form of dementia, is characterized by the loss of higher brain function such as memory, problem-solving abilities, and language. Photobiomodulation (PBM) desc...
Eligibility Criteria
Inclusion
- Inclusion Criteria (for participants with AD):
- 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
Exclusion
Key Trial Info
Start Date :
August 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2021
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT03405662
Start Date
August 16 2018
End Date
January 1 2021
Last Update
July 1 2022
Active Locations (2)
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1
VA Health Care System
San Francisco, California, United States, 94121
2
UCSF Memory and Aging Center
San Francisco, California, United States, 94158