Light Therapy for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+1 other location

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 medication

Disqualifiers: Severe sleep apnea, Epilepsy, others

Trial Summary

What is the purpose of this trial?

This trial uses special blue and red lights that either flicker regularly or randomly. It aims to see how these lights affect sleep and cognitive functions in general participants. Blue light helps regulate the body clock, and the flickering might have additional effects.

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

The trial protocol does not specify if you need to stop taking your current medications. However, if you are taking sleep medication, you cannot participate in the trial.

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

The available research shows that Light Therapy can be effective for people with Alzheimer's Disease. For example, using a self-luminous light table increased sleep quality and reduced agitation and depression. Another study found that tailored lighting improved sleep, mood, and behavior in people with Alzheimer's. However, one study using light visors did not find consistent improvements, possibly due to issues like the timing or method of light delivery. Overall, Light Therapy seems promising, especially when the light is delivered in a way that aligns with the body's natural rhythms. ^{1 2 3 4 5}

What safety data exists for light therapy in Alzheimer's treatment?

The safety data for light therapy in Alzheimer's treatment is limited and varies across studies. A pilot study using light visors found no consistent biological effects, possibly due to insufficient light exposure or advanced stages of Alzheimer's. Another study highlighted the potential of light therapy to regulate sleep-wake patterns in dementia patients, but methodological issues were noted. A review of light therapy studies indicated poor methodological quality, suggesting the need for better lighting descriptions and involvement of light specialists. Overall, while light therapy is established for other conditions like Seasonal Affective Disorder, its safety and efficacy in Alzheimer's require further investigation. ^{3 5 6 7 8}

Is Rhythmic Light Therapy a promising treatment for Alzheimer's Disease?

Yes, Rhythmic Light Therapy is promising for Alzheimer's Disease. It can improve sleep, reduce agitation, and help with depression. It is a non-drug option that uses light to help manage symptoms. ^{2 3 4 5 9}

Research Team

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

This trial is for people living at home or in assisted living with mild Alzheimer's or cognitive impairment, who have sleep issues but aren't on sleep meds. They can't join if they have severe eye problems, live in nursing care, or have certain neurological conditions.

Inclusion Criteria

I have mild cognitive issues or mild Alzheimer's, confirmed by a specific test score.

I live at home or in a facility that helps with daily activities.

I have trouble sleeping, as shown by my sleep test score.

Exclusion Criteria

I have severe sleep apnea or restless leg syndrome.

I do not have severe eye conditions like obstructing cataracts, macular degeneration, or blindness.

Residence in a skilled nursing facility or long-term care

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Participants undergo a baseline week before starting the assigned lighting condition

1 week

Treatment

Participants experience their assigned lighting condition for two hours in the morning for 8 weeks

8 weeks

8 assessments (in-person)

Washout

A 4-week washout period where no treatment is administered

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Rhythmic Light Therapy (Behavioural Intervention)

Trial Overview The study tests how different lights affect Alzheimer's patients' brains and sleep. Participants will try a placebo light or a circadian-effective light, both with either rhythmic or random flicker, for two hours each morning over eight weeks.

Participant Groups

Group I: Placebo Light plus Active Rhythm Active Control 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Group II: Active Intervention plus Active Rhythm Active Control 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Group III: Active Light plus Placebo Rhythm Active Control 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Group IV: Placebo Light plus Placebo Rhythm Placebo Group 2 Interventions

The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Icahn School of Medicine at Mount Sinai New York, NY

Light and Health Research Center Menands, NY

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Patients Recruited

579,000+

Findings from Research

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]

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]

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]

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]

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]

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]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Shedding a Light on Phototherapy Studies with People having Dementia: A Critical Review of the Methodology from a Light Perspective. Aarts, MP., Aries, MB., Diakoumis, A., et al.[2018]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). Wirz-Justice, A., Terman, AM.[2022]

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Actigraphy for Assessing Light Effects on Sleep and Circadian Activity Rhythm in Alzheimer's Dementia: A Narrative Review. Canazei, M., Turiaux, J., Huber, SE., et al.[2020]

References

1. 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]

2. 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]

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

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

6. 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]

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

Shedding a Light on Phototherapy Studies with People having Dementia: A Critical Review of the Methodology from a Light Perspective. [2018]

8. Switzerland pubmed.ncbi.nlm.nih.gov

CME: Light Therapy: Why, What, for Whom, How, and When (And a Postscript about Darkness). [2022]

9. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Actigraphy for Assessing Light Effects on Sleep and Circadian Activity Rhythm in Alzheimer's Dementia: A Narrative Review. [2020]