Impact of Photobiomodulation (PBM) on Biomarkers of Alzheimer's Disease
| Status: | Recruiting |
|---|---|
| Conditions: | Alzheimer Disease |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 10/3/2018 |
| Start Date: | August 16, 2018 |
| End Date: | December 31, 2019 |
| Contact: | Linda L Chao, PhD |
| Email: | linda.chao@ucsf.edu |
| Phone: | 415-221-4810 |
Examining the Impact of Photobiomodulation on Cognition, Behavior, and Biomarkers of Alzheimer's Disease
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 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.
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.
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) describes a kind of light therapy that uses red or near-infrared
light to stimulate, heal, regenerate, and protect tissue that has either been injured, is
degenerating, or else is at risk of dying. The pathological hallmarks of AD include senile
plaques rich in β-amyloid (Aβ) peptide and neurofibrillary tangles composed of
hyperphosphorylated tau (p-tau). In animal models of AD, PBM reduces the size and number of
brain Aβ plaques, p-tau, and neurofibrillary tangles. PBM also mitigates behavioral deficits
in transgenic AD mouse models and humans with dementia. The goal of this sham-controlled
pilot trial is to investigate the effects of PBM on the cognitive function, behavioral
symptoms, and fluid (i.e., cerebrospinal fluid (CSF) and blood) biomarkers of AD pathology
including amyloid burden, tangle pathology, axonal injury, microglia activation/inflammation,
and neurotrophic factors in 16 patients with biomarkers-supported probable Alzheimer's
dementia, according to the National Institute of Neurological and Communicative Disorders and
Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
One aim of the study is to examine the effect PMB on cognitive function and behavioral
symptoms in patients with probable AD. A second aim is to examine the effects of 16 weeks of
PBM on fluid biomarkers of inflammation (i.e., monocyte chemoattractant protein 1 and 3
[MCP-1 and MCP-3] and macrophage inflammatory protein 1β [MIP-1β]), neurodegeneration (i.e.,
ubiquitin carboxyl-terminal hydrolase isozyme L1 [UCH-L1] and neurofilament light chain
[NfL]) and neurotrophic factors (i.e., vascular endothelial growth factor [VEGF] and
brain-derived neurotrophic factor [BDNF]). The final aim of the study is to explore the
relationship between cognitive and behavioral changes after 16 weeks of PBM with changes in
biomarkers of inflammation, neurotrophic factors, and neurodegeneration.
Sixteen patients with biomarkers-supported probable Alzheimer's dementia will be enrolled and
randomly assigned to an active or sham PBM group. All patients will be asked to use the
Vielight Neuro Gamma (real or sham) device for 20 minutes/day, every other day, for 16 weeks.
Randomization with blind assignment will be determined by a computer-generated random
allocation. Upon completion of the post-treatment assessments, the Sham-treated patients will
be offered an opportunity to use an active Vielight Neuro Gamma device for 16 weeks. We will
assess cognition and behavioral symptoms in Sham patients who opt to undergo active PBM 16
weeks after they start the active PBM treatments.
Biomarker measures will be assessed in all study participants at baseline and after 16 weeks
of PBM. Biomarkers will be obtained through a blood draw and lumbar puncture. A lumbar
puncture (also called a spinal tap) is a procedure to collect cerebrospinal fluid, or CSF),
which surrounds the brain and spinal cord. During a lumbar puncture, a needle is carefully
inserted into the spinal canal low in the back (lumbar area).
Cognitive and behavioral function will be assessed in all study participants at baseline and
after 16 weeks of PBM. Study partners (e.g., caregivers) will be asked to answer questions
about the study participant's memory and daily functioning at baseline and after 16 weeks of
PBM. Study partners will also be trained and ask to help the study partners administer PBM
treatments with the Vielight Neuro Gamma device at home for 16 weeks.
higher brain function such as memory, problem-solving abilities, and language.
Photobiomodulation (PBM) describes a kind of light therapy that uses red or near-infrared
light to stimulate, heal, regenerate, and protect tissue that has either been injured, is
degenerating, or else is at risk of dying. The pathological hallmarks of AD include senile
plaques rich in β-amyloid (Aβ) peptide and neurofibrillary tangles composed of
hyperphosphorylated tau (p-tau). In animal models of AD, PBM reduces the size and number of
brain Aβ plaques, p-tau, and neurofibrillary tangles. PBM also mitigates behavioral deficits
in transgenic AD mouse models and humans with dementia. The goal of this sham-controlled
pilot trial is to investigate the effects of PBM on the cognitive function, behavioral
symptoms, and fluid (i.e., cerebrospinal fluid (CSF) and blood) biomarkers of AD pathology
including amyloid burden, tangle pathology, axonal injury, microglia activation/inflammation,
and neurotrophic factors in 16 patients with biomarkers-supported probable Alzheimer's
dementia, according to the National Institute of Neurological and Communicative Disorders and
Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria.
One aim of the study is to examine the effect PMB on cognitive function and behavioral
symptoms in patients with probable AD. A second aim is to examine the effects of 16 weeks of
PBM on fluid biomarkers of inflammation (i.e., monocyte chemoattractant protein 1 and 3
[MCP-1 and MCP-3] and macrophage inflammatory protein 1β [MIP-1β]), neurodegeneration (i.e.,
ubiquitin carboxyl-terminal hydrolase isozyme L1 [UCH-L1] and neurofilament light chain
[NfL]) and neurotrophic factors (i.e., vascular endothelial growth factor [VEGF] and
brain-derived neurotrophic factor [BDNF]). The final aim of the study is to explore the
relationship between cognitive and behavioral changes after 16 weeks of PBM with changes in
biomarkers of inflammation, neurotrophic factors, and neurodegeneration.
Sixteen patients with biomarkers-supported probable Alzheimer's dementia will be enrolled and
randomly assigned to an active or sham PBM group. All patients will be asked to use the
Vielight Neuro Gamma (real or sham) device for 20 minutes/day, every other day, for 16 weeks.
Randomization with blind assignment will be determined by a computer-generated random
allocation. Upon completion of the post-treatment assessments, the Sham-treated patients will
be offered an opportunity to use an active Vielight Neuro Gamma device for 16 weeks. We will
assess cognition and behavioral symptoms in Sham patients who opt to undergo active PBM 16
weeks after they start the active PBM treatments.
Biomarker measures will be assessed in all study participants at baseline and after 16 weeks
of PBM. Biomarkers will be obtained through a blood draw and lumbar puncture. A lumbar
puncture (also called a spinal tap) is a procedure to collect cerebrospinal fluid, or CSF),
which surrounds the brain and spinal cord. During a lumbar puncture, a needle is carefully
inserted into the spinal canal low in the back (lumbar area).
Cognitive and behavioral function will be assessed in all study participants at baseline and
after 16 weeks of PBM. Study partners (e.g., caregivers) will be asked to answer questions
about the study participant's memory and daily functioning at baseline and after 16 weeks of
PBM. Study partners will also be trained and ask to help the study partners administer PBM
treatments with the Vielight Neuro Gamma device at home for 16 weeks.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials