Light Therapy for Alzheimer's Disease

Overseen By Yijuan Zhu

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Sleep medications

Disqualifiers: Brain disease, Organ failure, Hypertension, Diabetes, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how light therapy might improve sleep and memory in people with mild cognitive impairment (MCI) or mild Alzheimer's disease. Many individuals with these conditions experience sleep difficulties, affecting their overall well-being. The study will test a home-based lighting treatment, known as Lighting Intervention Therapy, to determine if it can regulate sleep patterns and enhance brain function. It is suitable for those with diagnosed sleep issues related to MCI or Alzheimer's who have undergone a PET scan for amyloid protein buildup in the past year. As an unphased trial, this study offers a unique opportunity to contribute to understanding how light therapy can enhance daily life for those with MCI or Alzheimer's.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does mention that those taking sleep medications cannot participate. If you are on antidepressants, you can still join, but your medication type and dosage will be monitored.

What prior data suggests that this light therapy is safe for improving sleep and memory in Alzheimer's patients?

Research has shown that light therapy is generally safe for people with Alzheimer's and similar conditions. Some studies mention uncommon side effects like eye strain and headaches. Other research reports no major side effects, indicating that light therapy is often well-tolerated.

Various studies have found that light therapy can improve sleep, mood, and behavior in people with dementia. It can also reduce daytime naps and increase nighttime sleep. This suggests that the therapy not only helps with sleep and brain function but also appears to be a safe option for these patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for Alzheimer's disease focus on managing symptoms with medications like cholinesterase inhibitors and memantine. However, Lighting Intervention Therapy (LIT) offers a unique approach by using light exposure to potentially impact brain function and symptoms. Unlike drugs, LIT is non-invasive and can be administered at home, making it more accessible and less burdensome for patients. Researchers are excited about this therapy because it might provide an alternative or complementary option without the side effects associated with medication.

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

Research shows that light therapy can improve sleep and behavior in people with Alzheimer's disease and similar conditions. Studies have found that increased daylight exposure helps synchronize the body's natural clock, leading to better sleep and mood. One review of several studies found that light therapy not only improves sleep but also boosts thinking skills and reduces depression in people with dementia. Additionally, specially designed lighting can enhance overall sleep quality and lessen symptoms like aggression. In this trial, participants will receive either Light Intervention Therapy (LIT) or Sham LIT to evaluate these effects. These findings suggest that light therapy could effectively manage symptoms in people with mild cognitive impairment and Alzheimer's disease. ^{1 3 4 6 7}

Who Is on the Research Team?

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Priti Balchandani

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for people aged 50 and older with mild cognitive impairment or mild Alzheimer's disease, who have sleep disturbances. They must have had a PET scan showing amyloid protein in the past year and not live in long-term care facilities. Excluded are those with severe eye conditions, recent cataract surgery with certain lenses, on sleep meds, at risk of psychiatric hospitalization, or with other brain diseases.

Inclusion Criteria

I am between 50-85 years old, have a confirmed amyloid beta positive PET scan, and my dementia rating is between 0.5-9.0.

I am 50 years old or older.

Patients must have undergone PET scans to measure amyloid protein accumulation within the past year

Exclusion Criteria

I am not taking any sleep medication.

I have not had cataract surgery with a UV and blue light-blocking lens implant.

I haven't changed my mental health medications in the last 14 days.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Initial Light Treatment

Participants receive the first type of light treatment at home for 10 weeks

10 weeks

1 visit (in-person) at the end of the treatment

Washout Period

A 4-week break to diminish carryover effects of the first therapy arm

4 weeks

No visits

Second Light Treatment

Participants receive the second type of light treatment at home for 10 weeks

10 weeks

1 visit (in-person) at the end of the treatment

Follow-up

Participants are monitored for changes in brain volumes, sleep quality, and cognitive assessments

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Lighting Intervention Therapy
• Sham LIT

Trial Overview The study tests whether light therapy can improve sleep and memory in patients by influencing their circadian rhythms—the body's natural 24-hour cycle affected by light. Participants will receive either the actual Lighting Intervention Therapy (LIT) or a sham version to compare effects.

How Is the Trial Designed?

Group I: Light Intervention Therapy (LIT) then Sham LIT Active Control 2 Interventions

The LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT.

Group II: Sham LIT then Light Intervention Therapy Active Control 2 Interventions

LIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm.

Lighting Intervention Therapy is already approved in United States, China for the following indications:

Approved in United States as Light Therapy for:

• Sleep disorders in Alzheimer's disease
• Circadian rhythm disturbances

Approved in China as Light Therapy for:

• Alzheimer's disease-related sleep disturbances
• Behavioral symptoms in dementia

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Published Research Related to This Trial

A tailored lighting intervention using low-level bluish-white light significantly improved sleep quality and efficiency in nursing home residents with Alzheimer's disease and related dementias over a 4-week period.

The intervention also led to reductions in depression and agitation scores, indicating potential behavioral benefits alongside improved sleep, suggesting that light therapy could be a valuable nonpharmacological treatment for ADRD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored lighting intervention improves measures of sleep, depression, and agitation in persons with Alzheimer's disease and related dementia living in long-term care facilities. Figueiro, MG., Plitnick, BA., Lok, A., et al.[2022]

The 11-week study involving 35 individuals with Alzheimer's disease and related dementia showed that a tailored lighting intervention significantly improved circadian entrainment and sleep efficiency, while also reducing depression symptoms in participants.

Caregivers also benefited from the lighting intervention, experiencing improved circadian rhythms, sleep efficiency, and longer sleep duration, suggesting that this approach could be beneficial for other populations with sleep issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. Figueiro, MG., Hunter, CM., Higgins, P., et al.[2022]

A self-luminous light table effectively increased sleep duration and efficiency in individuals with Alzheimer's disease over a four-week intervention, compared to a baseline week.

The use of this light table also significantly reduced agitation and depression scores, highlighting its potential as a practical treatment method for improving sleep and mood in dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Note: A self-luminous light table for persons with Alzheimer's disease. Figueiro, MG., Plitnick, B., Rea, MS.[2020]

In a study of 46 institutionalized patients with severe Alzheimer's disease, morning bright light therapy significantly improved rest-activity rhythm in those with the most severe disruptions, indicating its potential as a targeted intervention.

However, the overall effectiveness of bright light therapy on sleep quality and rest-activity measures was limited, suggesting that it may not benefit all patients equally.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of morning bright light treatment for rest-activity disruption in institutionalized patients with severe Alzheimer's disease. Dowling, GA., Hubbard, EM., Mastick, J., et al.[2019]

A 14-week clinical trial with 46 patients showed that a tailored lighting intervention significantly improved sleep quality, as measured by the Pittsburgh Sleep Quality Index, compared to both baseline and control conditions.

The lighting intervention also led to notable improvements in mood and behavior, evidenced by reduced depression and agitation scores, indicating its potential as an effective nonpharmacological treatment for individuals with Alzheimer's disease and related dementias.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of a Tailored Lighting Intervention on Sleep Quality, Rest-Activity, Mood, and Behavior in Older Adults With Alzheimer Disease and Related Dementias: A Randomized Clinical Trial. Figueiro, MG., Plitnick, B., Roohan, C., et al.[2023]

A pilot study involving community-dwelling individuals with Alzheimer's disease tested the effects of phototherapy using light visors over a 10-day period, but did not find consistent improvements in sleep patterns or nighttime awakenings.

While one subject experienced increased total sleep time, the overall results suggest that factors like insufficient light exposure duration and the advanced stage of Alzheimer's may limit the effectiveness of light therapy in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Phototherapy for patients with Alzheimer disease with disturbed sleep patterns: results of a community-based pilot study. Colenda, CC., Cohen, W., McCall, WV., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4168854/

Tailored lighting intervention improves measures of sleep ... A lighting intervention, tailored to increase daytime circadian stimulation, can be used to increase sleep quality and improve behavior in patients with ADRD.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748123005171

The Effects of Light Therapy on Sleep, Depression ... This meta-analysis demonstrates that light therapy is effective in improving sleep, cognition, and decreasing depression and neuropsychiatric behaviors for PLWD ...

3. jcsm.aasm.org jcsm.aasm.org/doi/10.5664/jcsm.8078

Effects of a Tailored Lighting Intervention on Sleep Quality ... A lighting intervention tailored to maximally entrain the circadian system can improve sleep, mood, and behavior in patients with dementia ...

4. frontiersin.org frontiersin.org/journals/physiology/articles/10.3389/fphys.2023.1290678/full

Tailored lighting intervention (TLI) for improving sleep- ... This study demonstrates that a circadian-effective lighting intervention delivering bright days and dark nights improves measures of sleep and mood in dementia ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3553247/

Light Therapy and Alzheimer's Disease and Related ... Bright light does appear to be a treatment possibility for aggressive behavior in ADRD patients. Burns et al. [52] showed improvements in Cohen-Mansfield ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5836917/

Light, sleep and circadian rhythms in older adults with ... Adverse side effects of light therapy may include eye strain and headaches [51] although other studies did not show any significant differences in side effects ...

7. alzheimers.org.uk alzheimers.org.uk/about-dementia/treatments/alternative-therapies/light-therapy-and-dementia

Light therapy and dementia A large and well-conducted research review found that bright light therapy can result in less daytime sleeping and increased night-time sleeping. Current ...