Tailored Lighting for Alzheimer's Disease

Recruiting at 2 trial locations

Overseen By Barbara Plitnick, BSN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Disqualifiers: Insulin-dependent diabetes, Urinary incontinence, Cataracts, 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: 1

Duration: 24 weeks

61 Participants Needed

Trial Summary

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, since this study focuses on a lighting intervention and not a drug, it's likely you won't need to stop your medications. Please confirm with the trial coordinators.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

What data supports the idea that Tailored Lighting for Alzheimer's Disease is an effective treatment?

The available research shows that Tailored Lighting for Alzheimer's Disease can improve sleep, mood, and behavior in patients. One study found that using a self-luminous light table increased sleep quality and reduced agitation and depression. Another study demonstrated that a tailored lighting intervention improved sleep quality and mood in older adults with Alzheimer's. Additionally, personalized blue-enriched light was shown to help with rest-activity rhythms in patients with mild and moderate Alzheimer's. These findings suggest that tailored lighting is an effective treatment for improving various symptoms in Alzheimer's patients. ^{1 2 3 4 5}

What data supports the effectiveness of the Tailored Lighting Intervention treatment for Alzheimer's disease?

Research shows that tailored lighting can improve sleep quality, mood, and behavior in people with Alzheimer's by affecting their internal body clock (circadian system). Studies found that using specific lighting increased sleep efficiency and reduced agitation and depression in patients. ^{1 2 3 4 5}

What safety data exists for tailored lighting treatment in Alzheimer's?

The provided research does not explicitly mention safety data for tailored lighting treatments in Alzheimer's disease. However, the studies focus on the effectiveness of various light interventions, such as blue-enriched light, self-luminous light tables, and bright light therapy, in improving sleep, mood, and behavior in Alzheimer's patients. These interventions are generally non-invasive and aim to enhance circadian rhythms, suggesting a favorable safety profile, but specific safety data is not detailed in the abstracts. ^{1 4 5 6 7}

Is tailored lighting safe for humans?

The studies on tailored lighting for Alzheimer's disease suggest it is generally safe, as they focus on improving sleep and mood without reporting any harmful effects. ^{1 4 5 6 7}

Is the Tailored Lighting Intervention a promising treatment for Alzheimer's disease?

Yes, the Tailored Lighting Intervention is a promising treatment for Alzheimer's disease. It helps improve sleep quality, mood, and behavior by using special lighting to support the body's natural sleep-wake cycle. This approach can make life better for people with Alzheimer's by helping them sleep better and feel more balanced. ^{1 4 5 8 9}

How is the Tailored Lighting Intervention treatment different from other treatments for Alzheimer's disease?

The Tailored Lighting Intervention is unique because it uses specific light exposure to improve sleep, mood, and behavior in Alzheimer's patients by affecting their circadian system (the body's internal clock), unlike traditional treatments that often rely on medication. ^{1 4 5 8 9}

What is the purpose of this trial?

This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment and treating metabolic disease and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have the potential to provide important insights into the link between AD/ADRD and type 2 diabetes (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. If positive results are observed, the potential also exists to transform the manner in which homes, assisted living facilities, and nursing homes are lighted by delivering a simple, practical, non-pharmacological intervention to promote entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in controlled environments (i.e., assisted living facilities and nursing homes), will investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control, compared to a control, circadian-inactive light.

Research Team

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for individuals aged 60 or over with mild to moderate Alzheimer's disease or related dementia who have sleep disturbances. It excludes those with severe sleep apnea, restless leg syndrome, insulin-dependent diabetes, obstructing cataracts, or macular degeneration.

Inclusion Criteria

I am 60 years old or older.

You have trouble sleeping, which is confirmed by a score of 5 or higher on a sleep questionnaire.

I have been diagnosed with mild to moderate Alzheimer's or similar dementia.

Exclusion Criteria

I have cataracts that block my vision.

I use insulin for my diabetes.

I have severe sleep apnea or restless leg syndrome.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive an 8-week tailored lighting intervention (TLI) designed to increase circadian entrainment, followed by an 8-week washout period and then an 8-week placebo or active intervention depending on the crossover design.

24 weeks

Regular assessments during weeks 1, 5, 9, 18, 22, and 26

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Tailored Lighting Intervention

Trial Overview The study tests if a Tailored Lighting Intervention (TLI) can improve circadian rhythms and treat metabolic issues in Alzheimer's patients. The intervention involves an 8-week exposure to special lighting compared to inactive lighting in a controlled crossover setting.

Participant Groups

Group I: Aim 1: Placebo Intervention then Active Experimental Treatment 1 Intervention

The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.

Group II: Aim 1: Active Intervention then Placebo Experimental Treatment 1 Intervention

Tailored Lighting intervention (TLI). The active 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. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 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+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Findings from Research

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]

Increasing daytime environmental illumination for 4 weeks improved the stability of rest-activity rhythms in 22 dementia patients with intact vision, suggesting that light can positively influence circadian rhythms in this population.

However, the same increase in light did not benefit visually impaired patients, indicating that the effectiveness of light therapy may depend on visual capability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Indirect bright light improves circadian rest-activity rhythm disturbances in demented patients. Van Someren, EJ., Kessler, A., Mirmiran, M., et al.[2022]

In patients with mild to moderate Alzheimer's disease, light therapy tailored to their individual circadian rhythms significantly improved sleep quality and cognitive performance, indicating its potential as a beneficial intervention.

The study demonstrated that light therapy can induce a phase shift in circadian rhythms, which is linked to better sleep and cognitive outcomes, highlighting the importance of circadian regulation in managing Alzheimer's symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Circadian Phase Tailored Light Therapy on Sleep, Mood, and Cognition in Alzheimer's Disease: Preliminary Findings in a Pivotal Study. Cremascoli, R., Sparasci, D., Giusti, G., 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]

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]

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]

Increasing light exposure in nursing homes can significantly improve sleep quality and circadian rhythms in patients with Alzheimer's disease, as shown by wrist actigraphy measurements.

Both morning and evening bright light exposure led to more consolidated nighttime sleep and enhanced circadian activity patterns, suggesting that improving ambient light conditions could benefit dementia patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased light exposure consolidates sleep and strengthens circadian rhythms in severe Alzheimer's disease patients. Ancoli-Israel, S., Gehrman, P., Martin, JL., et al.[2007]

References

1. Korea (South) 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. [2023]

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

Indirect bright light improves circadian rest-activity rhythm disturbances in demented patients. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Effects of Circadian Phase Tailored Light Therapy on Sleep, Mood, and Cognition in Alzheimer's Disease: Preliminary Findings in a Pivotal Study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Research Note: A self-luminous light table for persons with Alzheimer's disease. [2020]

5. United States 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. [2023]

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

Phototherapy for patients with Alzheimer disease with disturbed sleep patterns: results of a community-based pilot study. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Effect of morning bright light treatment for rest-activity disruption in institutionalized patients with severe Alzheimer's disease. [2019]

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

Tailored Lighting Intervention for Persons with Dementia and Caregivers Living at Home. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Increased light exposure consolidates sleep and strengthens circadian rhythms in severe Alzheimer's disease patients. [2007]