N/A
N=14
Impact of Photobiomodulation (PBM) on Biomarkers of Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03405662 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Jul 2022
Primary outcome: Primary: Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog) — 0.94; 1.4 Ratio — p=0.07
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Vielight Neuro Gamma (Device); Sham Vielight Neuro Gamma (Other)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- University of California, San Francisco
- Primary completion
- Jan 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog) |
0.94; 1.4 | 0.07 |
| SECONDARY Change in Performance on Color Trails Test (CTT2/CTT1 Index) |
1.1; 1.2 | 0.29 |
| SECONDARY Change on the Neuropsychiatriac Inventory (NPI) |
1.1; 1.87 | 0.07 |
| SECONDARY Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) |
1.0; 0.9 | 0.23 |
| SECONDARY Change in Plasma Levels of Aβ42 |
0.92; 1.0 | 0.68 |
| SECONDARY Change in CSF Levels of Aβ42. |
0.4; 1.3 | 0.13 |
| SECONDARY Change in Plasma Levels of Tau. |
0.7; 1.0 | 0.32 |
| SECONDARY Change in CSF Levels of Tau |
0.7; 1.1 | 0.68 |
| SECONDARY Change in Plasma Levels of Neurofilament Light Chain (NfL) |
1.0; 1.2 | 0.86 |
| SECONDARY Change in CSF Levels of NfL |
0.6; 0.7 | 0.32 |
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 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 primary goal of this study is to determine if PBM administered transcranially (through the scalp and skull) and intranasally (inside the nose) with a commercially available device is safe and tolerable for patients with mild-to-moderate Alzheimer's disease (AD). Secondary goals are to examine whether tPBM has an effect on cognitive function and behavioral symptoms in patients with AD and whether tPBM has an effect on fluid biomarkers of AD. A biomarker is a specific physical trait used to measure the progress of a disease or condition.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03405662). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.