Impact of Photobiomodulation (PBM) on Biomarkers of Alzheimer's Disease

NCT03405662 | Completed Results FDA Device

• 1 other identifier: OsherRAP
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 2

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 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.

Conditions

Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Change in Alzheimer's Disease Assessment Scale-cognitive Subscale (ADAS-cog)

  The ADAS-cog is the most popular cognitive testing instrument used in clinical trials of nootropics. It consists of 11 tasks measuring the disturbances of memory, language, praxis, attention and other cognitive abilities which are often referred to as the core symptoms of AD. Higher ADAS-cog scores indicate greater cognitive impairment. The changes score was determined by calculating the ratio of the ADAS-cog score at week 16 over the ADAS-cog score at baseline. Thus, a change score of 1 signifies no change compared to baseline and change scores \< 1 or \> 1 reflect a decrease or an increase in ADAS-cog score compared to baseline.

  Baseline to 16 weeks

Secondary Outcomes (9)

• Change in Performance on Color Trails Test (CTT2/CTT1 Index)

  Baseline to 16 weeks

• Change on the Neuropsychiatriac Inventory (NPI)

  Baseline to 16 weeks

• Change on the Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL)

  Baseline to 16 weeks

• Change in Plasma Levels of Aβ42

  Baseline to 16 weeks

• Change in CSF Levels of Aβ42.

  Baseline to 16 weeks

Study Arms (2)

Acitve PBM

ACTIVE COMPARATOR

This arm will receive active photobiomodulation (PBM), delivered with the Vielight Neuro Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes for 16 weeks.

Device: Vielight Neuro Gamma

Sham PBM

SHAM COMPARATOR

This arm will not receive active photobiomodulation (PBM). Instead, they will use a sham Vielight Neuro Gamma device, once every other day (e.g., Mon, Wed, Fri) for 20 minutes for 16 weeks.

Other: Sham Vielight Neuro Gamma

Interventions

Vielight Neuro Gamma DEVICE

The Vielight Neuro Gamma is headset that delivers transcranial (through the scalp and skull) and intranasal (through the nose) near infrared (NIR) light. The device is engineered for increased efficacy and easy domestic use for comprehensive brain photobiomodulation (PBM). The NIR lights are pulsed at a 40 Hz rate, which correlates with electroencephalogram (EEG) gamma brain wave entrainment.

Acitve PBM

Sham Vielight Neuro Gamma OTHER

The Sham Vielight Neuro Gamma headset is identical to the active Vielight Neuro Gamma headset and intranasal light emitting diode (LED) except it has a power output of 0.

Sham PBM

Eligibility Criteria

• Age: 50 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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
• major neurological or psychiatric condition
• terminal illness (i.e., life expectancy \< 1 year)
• evidence of cognitive impairment
• inability to consent to study procedure

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (2)

VA Health Care System

San Francisco, California, 94121, United States

Location

UCSF Memory and Aging Center

San Francisco, California, 94158, United States

Location

Related Publications (5)

• De Taboada L, Yu J, El-Amouri S, Gattoni-Celli S, Richieri S, McCarthy T, Streeter J, Kindy MS. Transcranial laser therapy attenuates amyloid-beta peptide neuropathology in amyloid-beta protein precursor transgenic mice. J Alzheimers Dis. 2011;23(3):521-35. doi: 10.3233/JAD-2010-100894.

  PMID: 21116053 BACKGROUND

• Purushothuman S, Johnstone DM, Nandasena C, Mitrofanis J, Stone J. Photobiomodulation with near infrared light mitigates Alzheimer's disease-related pathology in cerebral cortex - evidence from two transgenic mouse models. Alzheimers Res Ther. 2014 Jan 3;6(1):2. doi: 10.1186/alzrt232. eCollection 2014.

  PMID: 24387311 BACKGROUND

• Berman MH, Halper JP, Nichols TW, Jarrett H, Lundy A, Huang JH. Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition. J Neurol Neurosci. 2017;8(1):176. doi: 10.21767/2171-6625.1000176. Epub 2017 Feb 28.

  PMID: 28593105 BACKGROUND

• Sommer AP, Bieschke J, Friedrich RP, Zhu D, Wanker EE, Fecht HJ, Mereles D, Hunstein W. 670 nm laser light and EGCG complementarily reduce amyloid-beta aggregates in human neuroblastoma cells: basis for treatment of Alzheimer's disease? Photomed Laser Surg. 2012 Jan;30(1):54-60. doi: 10.1089/pho.2011.3073. Epub 2011 Oct 26.

  PMID: 22029866 BACKGROUND

• Grillo SL, Duggett NA, Ennaceur A, Chazot PL. Non-invasive infra-red therapy (1072 nm) reduces beta-amyloid protein levels in the brain of an Alzheimer's disease mouse model, TASTPM. J Photochem Photobiol B. 2013 Jun 5;123:13-22. doi: 10.1016/j.jphotobiol.2013.02.015. Epub 2013 Mar 22.

  PMID: 23603448 BACKGROUND

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Dr. Linda Chao
• Organization: University of California, San Francisco & San Francisco VA Health Care System

linda.chao@ucsf.edu

415-221-4810

Study Officials

• Linda L Chao, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blind assignment determined by a computer-generated random allocation schedule
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants randomized to the "Active PBM" group will use an active Vielight Neuro device, for 16 weeks, once every other day (e.g., Mon, Wed, Fri) for 20 minutes. Participants randomized to the "Sham PBM" group will use a a sham Vielight Neuro device, for 16 weeks, once every other day (e.g., Mon, Wed, Fri) for 20 minutes. All study participants will undergo cognitive and behavioral assessments, blood draw, and lumbar puncture at baseline (before using Vielight Neuro Gamma device) and after 16 weeks of using the Vielight Neuro Gamma device. Upon completion of the post-16 week assessments, blood draw, and lumbar puncture, patients randomized to the Sham PBM group 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 active PBM treatments.

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: January 23, 2018
• Study Start: August 16, 2018
• Primary Completion: January 1, 2021
• Study Completion: January 1, 2021
• Last Updated: July 1, 2022
• Results First Posted: July 1, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)