Light Therapy for Alzheimer's Disease

Overseen by Mariana Figueiro, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

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

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?

The purpose of this research study is to investigate the effect of a light treatment on sleep, memory and brain function. In people with mild cognitive impairment (MCI) and Alzheimer's disease, sleep-wake disturbance is evident in up to 60% of patients. This can be caused by disruption of circadian rhythms and may affect our health and well-being. Circadian rhythms are the natural cycle of physical, mental, and behavior changes that the body goes through in a 24-hour cycle. Circadian rhythms are mostly affected by light and darkness and are controlled by a small area in the middle of the brain. They can affect sleep, body temperature, hormones, appetite, and other body functions. The circadian system plays an important role in the body and can affect sleep and brain function. The results of the research would help develop light-delivery methods to improve sleep and memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease who typically spend a significant amount of time indoors.

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 data supports the effectiveness of the treatment Light Therapy for Alzheimer's Disease?

Research shows that light therapy can help improve sleep quality, reduce agitation, and decrease depression in people with Alzheimer's disease. Studies found that using light, especially in the morning, can help regulate sleep patterns and improve mood and behavior. ^{1 2 3 4 5}

Is light therapy safe for humans, especially those with Alzheimer's disease?

Light therapy has been studied in people with Alzheimer's disease and related conditions, and it is generally considered safe. Some studies have shown improvements in sleep and behavior without significant safety concerns. ^{1 2 4 5 6}

How is light therapy different from other treatments for Alzheimer's disease?

Light therapy is unique because it uses specific wavelengths of light to help regulate sleep patterns and improve mood and behavior in Alzheimer's patients without using medication. It targets the body's natural circadian rhythms (internal body clock) and can be delivered through practical methods like self-luminous light tables, making it a non-drug option for managing symptoms. ^{2 3 4 5 6}

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

Eligibility Criteria

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.

Trial Timeline

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)

Treatment Details

Interventions

• Lighting Intervention Therapy (Behavioural Intervention)
• Sham LIT (Light Therapy)

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.

Participant Groups

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 China for the following indications:

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+

Dr. Brendan Carr

Icahn School of Medicine at Mount Sinai

Chief Executive Officer since 2024

MD, MA, MS

Dr. Vicki LoPachin

Icahn School of Medicine at Mount Sinai

Chief Medical Officer

MD, FACP, MBA

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Dr. Richard J. Hodes

National Institute on Aging (NIA)

Chief Executive Officer since 1993

MD from Harvard Medical School

Dr. Marie Bernard

National Institute on Aging (NIA)

Chief Medical Officer

MD from Harvard Medical School

Findings from Research

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 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 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]

References

1. 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]

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

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

3. 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]

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

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

5. 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]

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]