Light Therapy for Alzheimer's Disease

Recruiting at 1 trial location

Overseen By Adam J Woods, Ph.D.

Age: 65+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Florida

Must not be taking: Antipsychotics, Sedatives, Aricept, Namenda

Disqualifiers: Sensory loss, Major strokes, Uncontrolled conditions, Psychiatric disturbance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

168 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

You may need to stop taking certain medications, such as antipsychotics, sedatives, medications with anticholinergic properties, 'memory enhancing' medications like Aricept or Namenda, and photo-sensitive medications like steroids or retin-A within 15 days of the study. It's best to discuss your specific medications with the study team.

What data supports the effectiveness of the treatment NIR-PBM, Photobiomodulation, Near-Infrared Light Therapy, Transcranial and Intranasal Near-Infrared Light Stimulation for Alzheimer's Disease?

Research shows that using near-infrared light therapy can improve cognitive function in people with mild to moderate dementia, including Alzheimer's. Studies in mice and small human trials suggest this treatment may help reduce harmful brain plaques and improve brain function by increasing blood flow and oxygen levels. ^{1 2 3 4 5}

Is light therapy safe for humans?

Research on light therapy, including near-infrared photobiomodulation, suggests it is generally safe for humans, with studies showing improvements in cognitive functions in dementia patients and no significant safety concerns reported. ^{1 2 3 4 5}

How is the treatment NIR-PBM for Alzheimer's disease different from other treatments?

NIR-PBM (Near-Infrared Photobiomodulation) is unique because it uses light therapy to penetrate the brain and stimulate cellular energy production, improve blood flow, and clear harmful proteins, unlike traditional drug treatments that often focus on chemical pathways. ^{1 2 4 5 6}

What is the purpose of this trial?

The goal of this multi-site double blinded randomized sham-controlled Phase II clinical trial is to test a novel, relatively low cost, low risk, and potentially high impact therapeutic intervention in older adults who are at increased risk for Alzheimer's disease. The intervention involves transcranial and intranasal delivery of near infrared (NIR) light via light emitting diodes, aka photobiomodulation. The overall hypothesis, based on animal and pilot studies, is that exposure to NIR stimulation will have beneficial effects on brain health via influence on mitochondrial function as measured by changes in 31P MRS-based markers of ATP, neural network changes in functional connectivity (rs-fMRI), and improved cognitive performance. To test this hypothesis, 168 older adults with subjective cognitive complaints, and a first-degree family history of Alzheimer's disease will be randomized to sham or real treatment groups. Neuromiaging and ocgnitive outcome measures will be obtained, before and after a 12-week intervention involving transcranial and intranasal NIR-PBM. The intervention protocol will involve "lab" and "home" sessions, and a 3 month post-intervention follow-up. This trial will determine: 1) whether NIR stimulation, relative to sham, improves performance on memory and executive tasks sensitive to hippocampal and frontal brain function in older adults with increased risk for Alzheimer's disease; 2) whether NIR stimulation, relative to sham, enhances brain function and connectivity measured by changes in MRS phosphorous ATP and resting state functional connectivity; and 3) how differences in demographic, neuroimaging, and Alzheimer-related risk factors influence the brain response to NIR stimulation versus sham in older adults with increased risk for Alzheimer's disease. Results will provide key insights into whether this novel NIR intervention can enhance cognition in older adults with increased risk for Alzheimer's disease and will provide the necessary data for a future Phase III randomized clinical trial.

Research Team

Adam J Woods, PhD

Principal Investigator

University of Florida

Gene Alexander, Ph.D.

Principal Investigator

University of Arizona

Dawn Bowers, Ph.D

Principal Investigator

University of Florida

Eligibility Criteria

This study is for older adults aged 65-89 with subjective cognitive complaints and a family history of Alzheimer's. Participants must have normal cognitive function based on specific tests, be able to perform computer-based tasks, and commit to a 12-week intervention plus testing. An informant must corroborate their daily functioning.

Inclusion Criteria

Reading at > 8th grade level based on the reading subtest of the Wide Range Achievement Test- IV

You should not have any signs of memory or thinking problems.

I am between 65-89 years old, have completed at least 8th grade, and live in a community.

Exclusion Criteria

I have not had major strokes, brain diseases like Parkinson's, or significant brain surgeries.

You have participated in a cognitive training study in the last 6 months or are currently involved in another study that includes cognitive or physical activities.

I am not taking antipsychotics, sedatives, or medications that heavily affect memory.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive transcranial and intranasal NIR-PBM for 12 weeks, including 16 lab sessions and 44 home sessions

12 weeks

16 lab visits (in-person), 44 home sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

1 visit (in-person)

Treatment Details

Interventions

• NIR-PBM

Trial Overview The trial is examining the effects of near-infrared (NIR) light therapy on brain health in those at risk for Alzheimer's disease. It involves transcranial and intranasal NIR delivered through LEDs compared against sham treatment over a period of 12 weeks with follow-up.

Participant Groups

Group I: Active NIR-PBM Experimental Treatment 1 Intervention

For transcranial stimulation, the study team will use two MedX units (1116 Rehab Console, MedX Health), whereas intranasal stimulation is delivered using the 810 Intranasal device (Vielight Inc). During each lab session, six transcranial LED clusters will be placed on the scalp in two distinct configurations guided by 10-20 EEG system. Total transcranial stimulation time is 40 minutes, 20 min per cluster. Concurrently, two 810 intranasal devices will be placed in each nostril for 25 min of total dose per nostril. For at home sessions, participants will use the standalone 810 Intranasal device only. Total amount of sessions: 1. 16 sessions of stimulation will occur in the laboratory. Each session will last approximately 90 minutes and will include two 20-minute segments of NIR stimulation. AND 2. 44 sessions of intranasal stimulation in the home. Each session will last 25 minutes and will occur on weekdays when there is no in-lab session.

Group II: Sham NIR-PBM Placebo Group 1 Intervention

Participants randomized to the Sham control group will undergo identical procedures as the Active group. The only difference is that the "sham" NIR devices are modified not to deliver stimulation. Because NIR is invisible, participants are unable to detect whether NIR is being delivered.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Findings from Research

In a study involving 5 patients with mild to moderately severe dementia, treatment with near-infrared photobiomodulation (PBM) therapy for 12 weeks led to significant cognitive improvements, as measured by the Mini-Mental State Exam (MMSE) and Alzheimer's Disease Assessment Scale (ADAS-cog).

The therapy was associated with positive changes in daily functioning, sleep quality, and reduced anxiety, with no reported negative side effects, highlighting PBM's potential as a safe and effective home treatment option for dementia and Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report. Saltmarche, AE., Naeser, MA., Ho, KF., et al.[2022]

This study will evaluate the efficacy and safety of transcranial photobiomodulation (t-PBM) in improving cognitive function in participants with amnestic mild cognitive impairment (aMCI) and early Alzheimer's disease (AD) through 24 treatment sessions over 8 weeks.

The research aims to explore the underlying brain mechanisms of t-PBM, including its effects on tau burden and mitochondrial function, as well as its ability to increase blood flow in the prefrontal cortex, which could provide insights into how this therapy may enhance cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protocol Report on the Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) Study. Iosifescu, DV., Song, X., Gersten, MB., et al.[2023]

A small pilot study involving 11 participants with dementia showed that transcranial near infrared (NIR) light stimulation improved various cognitive functions, including executive functioning and memory tasks, after 28 sessions of treatment.

NIR light treatment was associated with neuroplasticity and potential mitochondrial enhancement, suggesting a novel approach to addressing Alzheimer's disease pathology, particularly in reducing amyloid plaques and improving cognitive performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition. Berman, MH., Halper, JP., Nichols, TW., et al.[2022]

Transcranial photobiomodulation (tPBM) significantly improved neurocognitive function in mice with Alzheimer's disease, reducing their neurological severity score from 3.67 to 2.03 after treatment, indicating its potential efficacy as a non-drug therapy.

The mechanism of tPBM involves enhancing the clearance of beta-amyloid from the brain and increasing blood oxygen saturation, suggesting it could be a promising strategy for preventing or delaying Alzheimer's disease progression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation of Clearance of Beta-Amyloid from the Mouse Brain: Effects on the Meningeal Lymphatic Drainage and Blood Oxygen Saturation of the Brain. Semyachkina-Glushkovskaya, O., Klimova, M., Iskra, T., et al.[2023]

The RGn500 device, which combines photonic and magnetic emissions, showed a neuroprotective effect in a mouse model of Alzheimer's disease when applied daily for 10 minutes, leading to memory restoration and normalization of key Alzheimer's markers.

This treatment demonstrated similar therapeutic efficacy to traditional pharmacological approaches, suggesting it could be a promising alternative for managing Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Neuroprotective effect of a new photobiomodulation technique against Aβ25-35 peptide-induced toxicity in mice: Novel hypothesis for therapeutic approach of Alzheimer's disease suggested. Blivet, G., Meunier, J., Roman, FJ., et al.[2022]

Brain photobiomodulation (PBM) therapy, which uses red to near-infrared light, enhances neuronal metabolism and promotes beneficial processes like neurogenesis and anti-inflammatory responses, making it a promising treatment for conditions such as dementia, Parkinson's disease, and depression.

Challenges in delivering effective doses of light to the brain through the transcranial method have led to the exploration of alternative delivery methods, such as intracranial and intranasal approaches, to improve treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brain Photobiomodulation Therapy: a Narrative Review. Salehpour, F., Mahmoudi, J., Kamari, F., et al.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

Significant Improvement in Cognition in Mild to Moderately Severe Dementia Cases Treated with Transcranial Plus Intranasal Photobiomodulation: Case Series Report. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Protocol Report on the Transcranial Photobiomodulation for Alzheimer's Disease (TRAP-AD) Study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Photobiomodulation with Near Infrared Light Helmet in a Pilot, Placebo Controlled Clinical Trial in Dementia Patients Testing Memory and Cognition. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Transcranial Photobiomodulation of Clearance of Beta-Amyloid from the Mouse Brain: Effects on the Meningeal Lymphatic Drainage and Blood Oxygen Saturation of the Brain. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Neuroprotective effect of a new photobiomodulation technique against Aβ25-35 peptide-induced toxicity in mice: Novel hypothesis for therapeutic approach of Alzheimer's disease suggested. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Brain Photobiomodulation Therapy: a Narrative Review. [2020]