Light Therapy for Alzheimer's Disease

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new light therapy method for individuals at increased risk for Alzheimer's disease. The therapy, known as NIR-PBM (Near-Infrared Photobiomodulation), uses near-infrared (NIR) light delivered through the head and nose to potentially improve brain function and memory. Participants will be divided into groups receiving either the actual light therapy or a non-working version (sham) for comparison. Ideal candidates for this trial are older adults who have noticed memory issues and have a close family member with Alzheimer's. The trial aims to determine if this light therapy can enhance memory and brain connections, paving the way for future studies. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

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 prior data suggests that this light therapy is safe for older adults at risk for Alzheimer's disease?

Research has shown that Near Infrared Photobiomodulation (NIR-PBM) is generally safe for people. One study found that NIR light treatments were well-tolerated by patients with dementia, with no major side effects. Some patients even experienced improvements in their cognitive abilities. Another study suggested that this type of light therapy might help treat conditions like Alzheimer’s and Parkinson’s diseases by slowing the loss of nerve cells.

This therapy remains in the early stages of testing, so researchers continue to study its safety and effectiveness. However, existing research and its use in other areas suggest it is relatively safe. As with any treatment, individual experiences can differ, so discussing any concerns with a healthcare provider is always advisable. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for Alzheimer's?

Researchers are excited about Near Infrared-Photobiomodulation (NIR-PBM) for Alzheimer's Disease because it offers a novel approach compared to traditional treatments like cholinesterase inhibitors and memantine, which mainly focus on managing symptoms. NIR-PBM works by using light therapy to potentially stimulate brain activity and improve cognitive function, which is a fresh mechanism of action in Alzheimer's care. Additionally, this therapy is administered non-invasively through devices placed on the scalp and intranasally, making it an innovative and potentially more convenient option for patients. The use of light to influence brain health is a cutting-edge area of exploration, sparking interest due to its potential to address the disease's root causes rather than just its symptoms.

What evidence suggests that this light therapy is effective for Alzheimer's disease?

Research has shown that near-infrared photobiomodulation (NIR-PBM), a treatment participants in this trial may receive, might improve brain function in individuals at risk for Alzheimer's disease. Studies have found that NIR-PBM can enhance memory and thinking skills in people with dementia by stimulating brain tissues. It reduces inflammation and stress in the brain, protecting brain cells and improving overall brain health. In animal studies, this treatment also improved memory and the connectivity between different brain regions. These findings suggest that NIR-PBM could be a promising option for those experiencing cognitive decline related to Alzheimer's. ^{1 4 5 6 7}

Who Is on the Research Team?

Steve DeKosky, M.D.

Principal Investigator

University of Florida

Gene Alexander, Ph.D.

Principal Investigator

University of Arizona

Dawn Bowers, Ph.D

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Active NIR-PBM Experimental Treatment 1 Intervention

This condition involves baseline testing, 12 weeks of Near Infrared-Photobiomodulation (NIR-PBM), and post-intervention testing. Cognitive and neuroimaging outcomes are obtained before and after the intervention. The intervention consists of a) 16 laboratory sessions of NIR-PBM given 3 times/week for 2 weeks and then once weekly for 10 weeks and b) 44 home sessions of stimulation delivered intranasally. During each lab session, NIR light is delivered via placement of six MedX LED superluminous diode clusters over the scalp for a total of 40 minutes. Concurrently, two 810 Vielight intranasal devices are placed in each nostril for 25 min of total dose per nostril. During lab sessions, participants sit in front of a monitor and view nature documentaries (BBC Life series). This is done to standardize behavior during the intervention sessions. For home sessions, participants use a standalone 810 intranasal device only on weekdays when not completing a 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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11258032/

A randomized sham-controlled trial of transcranial and ... Transcranial near infrared light stimulations improve cognition in patients with dementia. Aging Dis. (2021) 12:954–63. doi: 10.14336/AD.2021.0229, PMID ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12321612/

Brain photobiomodulation: a potential treatment in Alzheimer's ... Preclinical investigations demonstrated that brain photobiomodulation (bPBM) reduces oxidative stress and inflammation, increases cerebral blood ...

3. frontiersin.org frontiersin.org/journals/neuroscience/articles/10.3389/fnins.2024.1417178/full

Near-infrared light stimulation regulates neural oscillation ... Low-intensity near-infrared light (1–500 mw) has demonstrated the ability to improve memory in Alzheimer's disease (AD) model mice, suggesting ...

4. nature.com nature.com/articles/s41598-019-42693-x

Pulsed Near Infrared Transcranial and Intranasal ... Transcranial photobiomodulation (tPBM) is the application of low levels of red or near-infrared (NIR) light to stimulate neural tissues.

5. alzres.biomedcentral.com alzres.biomedcentral.com/articles/10.1186/s13195-024-01484-x

Photobiomodulation in experimental models of Alzheimer's ... In this review, we discuss the potential of photobiomodulation (PBM) for preventing and alleviating AD-associated pathologies, with a focus on the biological ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S227458072500130X

a potential treatment in Alzheimer's and Parkinson's diseases Turning on lights to stop neurodegeneration: the potential of Near Infrared light therapy in Alzheimer's and Parkinson's disease. Front Neurosci, 9 (2016).

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8219492/

Transcranial Near Infrared Light Stimulations Improve ... The tNIR light treatments demonstrated safety and positive cognitive improvements in patients with dementia.