Tailored Lighting for Alzheimer's Disease

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special kind of lighting, known as the Tailored Lighting Intervention, can benefit people with mild to moderate Alzheimer's or related dementias. The researchers aim to determine if tailored lighting improves sleep, mood, and reduces inflammation and metabolic issues. Participants will spend eight weeks under two types of lighting: one designed to help and another that does not affect the body clock. Individuals with Alzheimer's and sleep difficulties may be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance the quality of life for those with Alzheimer's.

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 prior data suggests that this tailored lighting intervention is safe for Alzheimer's patients?

Research has shown that special lighting, known as tailored lighting interventions (TLI), is generally safe and well-tolerated by patients. Studies have found that TLI can improve sleep and mood in people with dementia. For example, one study found that using bright lights during the day and dim lights at night improved sleep and mood without major side effects. Another study showed that TLI improved behavior and sleep quality in individuals with Alzheimer's and similar conditions. Although these studies did not report serious side effects, monitoring one's response to any new treatment remains important. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the tailored lighting intervention for Alzheimer's disease because it offers a non-drug approach to managing symptoms by targeting the circadian system. Unlike traditional treatments that often involve medications like cholinesterase inhibitors or memantine, tailored lighting uses light spectra specifically tuned to influence the body's internal clock, potentially improving sleep and mood in just weeks. This method is unique because it provides high circadian stimulation during the day, setting it apart from standard care options that do not address circadian rhythms directly.

What evidence suggests that this tailored lighting intervention is effective for Alzheimer's disease?

This trial will evaluate the effectiveness of a Tailored Lighting Intervention (TLI) for Alzheimer's disease. Studies have shown that special lighting can improve sleep and mood in people with Alzheimer's disease and similar conditions. Research indicates that daytime light exposure can regulate the body's internal clock, leading to better sleep and behavior. Other findings show that bright days and dark nights can boost mood and reduce depression symptoms in dementia patients. This method does not involve medication, providing a simple way to enhance well-being for those with cognitive disorders. Overall, evidence suggests that this lighting approach can significantly help manage symptoms related to Alzheimer's and similar conditions. Participants in this trial will experience both the active TLI and a placebo intervention in different phases to assess the impact of the lighting intervention. ^{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 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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

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]

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]

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

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. 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.

5. 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01816152?tab=table

Methodology Issues in a Tailored Light Treatment ... Subjects are asked to wear a calibrated light meter to obtain light/dark and activity/rest patterns for 7 days prior to intervention and for 7 days after 3 ...

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 ...