Light Therapy for Alzheimer's Disease

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

23 Participants Needed

Trial Summary

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

Research shows that using light therapy, like a self-luminous light table, can improve sleep and reduce agitation and depression in people with Alzheimer's. Tailored lighting interventions have been found to positively affect sleep quality, mood, and behavior in those with Alzheimer's and related dementias. ^{1 2 3 4 5}

Is light therapy safe for people with Alzheimer's disease?

Research on light therapy for Alzheimer's disease suggests it is generally safe, with studies showing improvements in sleep, mood, and behavior without significant adverse effects. ^{1 2 3 4 5}

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 regulate sleep-wake patterns and improve mood and behavior in Alzheimer's patients, focusing on blue-enriched light to stimulate the circadian system, unlike traditional drug treatments. ^{1 4 5 6 7}

What is the purpose of this trial?

To test the long term effect of a light treatment on cognition, sleep and metabolism in patients with Mild cognitive impairment (MCI) or mild Alzheimer's disease or related dementia (ADRD).

Research Team

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

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]

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 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]

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]

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]

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. 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]

3. 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]

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

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

7. New Zealand 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. [2022]