Light Therapy for Alzheimer's Disease

No longer recruiting at 1 trial location

Overseen By Barbara Plitnick, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Blindness, Insulin-dependent diabetes, others

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

Compensation: Varies

Number of Visits: 61

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a special light treatment called Tailored Lighting Intervention to improve thinking, sleep, and metabolism in people with mild cognitive impairment or mild Alzheimer's disease. Participants are divided into two groups: one receives the active light treatment that stimulates the body's internal clock, while the other receives placebo lighting without this effect. The trial spans 24 weeks to assess any long-term benefits. It suits individuals with mild memory problems or Alzheimer's, who experience sleep issues, and live at home. As an unphased trial, this study allows participants to contribute to innovative research that could enhance the quality of life for those with cognitive challenges.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this light therapy is safe for patients with mild cognitive impairment or mild Alzheimer's disease?

Previous studies have shown that a special lighting setup is well-tolerated by people with dementia. Research indicates that this light therapy can improve sleep and mood without significant side effects. One study found that using this lighting during the day improved sleep quality and behavior in patients with Alzheimer's disease and similar conditions. Another study showed that the lighting setup reduced the time patients were awake at night and increased their overall sleep time. These findings suggest that the treatment is safe and can effectively improve sleep and mood in patients with mild cognitive impairment or mild Alzheimer's disease. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using tailored lighting interventions for Alzheimer's disease because this approach offers a novel way to stimulate the circadian system, which is not a focus of standard treatments. Most Alzheimer's treatments today are medications that target brain chemistry to slow symptoms. However, this lighting intervention uses specific light spectra and intensity to improve circadian rhythms, potentially improving sleep and overall well-being in patients. By providing bluish-white light at specific intensities during the day, it aims to enhance alertness and mood, which could lead to better daily functioning and quality of life for those with Alzheimer's.

What evidence suggests that the Tailored Lighting Intervention is effective for Alzheimer's disease?

Research shows that special lighting can help people with Alzheimer's and similar types of dementia sleep better, feel better, and behave more positively. Studies have found that these lighting changes increase exposure to light during the day, helping to set a regular sleep schedule and improve thinking skills. In this trial, participants will receive either an Active Lighting Intervention or a Placebo Lighting Intervention. The Active Lighting Intervention is designed to activate the body's internal clock, which controls sleep and wake cycles. Evidence suggests that targeting this system with light can improve sleep and reduce dementia symptoms. This method aims to make the day-night cycle feel more natural, benefiting those with memory and thinking problems. ^{1 2 3 6 7}

Who Is on the Research Team?

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Are You a Good Fit for This Trial?

This trial is for people with mild cognitive impairment or early Alzheimer's who have trouble sleeping and live at home. It's not suitable for those who are blind, need insulin for diabetes, have severe vision loss from macular degeneration, or serious sleep apnea.

Inclusion Criteria

Live at home

I have been diagnosed with mild Alzheimer's Disease.

I have mild memory or thinking problems.

Exclusion Criteria

You are unable to see.

I use insulin to manage my diabetes.

I have macular degeneration.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a tailored light intervention (TLI) or placebo lighting intervention for 24 weeks to improve sleep, cognition, and metabolic control

24 weeks

Visits at Baseline, week 13, and week 25

Follow-up

Participants are monitored for long-term effects on sleep, cognition, and metabolic control

24 weeks

Visits at week 48

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Lighting Intervention

Trial Overview The study is looking into how a special lighting setup in the home can affect thinking abilities, sleep quality, and body metabolism over time in individuals with mild memory problems or early Alzheimer's disease.

How Is the Trial Designed?

Group I: Active Lighting Intervention Active Control 1 Intervention

The TLI will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. Combining spectrum and light level, TLI will allow us to: (a) use a light source that will stimulate the circadian system, and (b) provide the participants with options as to how the light treatment will be delivered. The investigators will deliver at least 300-400 lux at the eye of the bluish-white light during the day (CS of 0.4 or greater). The lighting intervention will be in place for 24 weeks

Group II: Placebo Lighting Intervention Placebo Group 1 Intervention

The placebo condition light source will be a warm yellow - white (2700 - 3000 K) source providing 50 -100 lux at the eye. The lighting intervention will be in place for 24 weeks.

Tailored Lighting Intervention is already approved in United States, Canada for the following indications:

Approved in United States as Tailored Lighting Intervention for:

• Sleep disturbances in Alzheimer's disease and related dementia (ADRD)
• Improvement of cognition and metabolism in Mild Cognitive Impairment (MCI) or mild Alzheimer's disease

Approved in Canada as Tailored Lighting Intervention for:

• Sleep disturbances in Alzheimer's disease and related dementia (ADRD)

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

Published Research Related to This Trial

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 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]

A personalized light intervention significantly improved the rest-activity rhythm (RAR) in Alzheimer's disease patients, showing reduced variability four weeks after the intervention, indicating better sleep patterns.

The intervention also positively affected the light exposure rhythm (LER) immediately after treatment, suggesting that tailored light exposure can help regulate daily rhythms in patients with Alzheimer's disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Personalized Blue-Enriched White Light Intervention on Rest-Activity and Light Exposure Rhythms in Mild and Moderate Alzheimer's Disease. Kim, SJ., Lee, JH., Jang, JW., et al.[2023]

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]

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 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]

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

Tailored lighting intervention (TLI) for improving sleep- ... Research has shown that lighting interventions can regulate the timing of sleep, improve sleep quality and cognition, and reduce symptoms of ...

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10759231/

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2352721815001485

Tailored lighting intervention for persons with dementia ... The present study investigated the effectiveness of a lighting intervention designed to increase circadian stimulation during the day.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03777722

Light and the Effect on Metabolic Syndrome ... This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment ...

7. alz-journals.onlinelibrary.wiley.com alz-journals.onlinelibrary.wiley.com/doi/abs/10.1002/alz.037168

Measuring dose in a tailored lighting intervention to improve ... Compared to their respective baseline conditions, the active lighting intervention significantly decreased wake percent and increased sleep ...