Light Therapy for Mild Cognitive Impairment

No longer recruiting at 2 trial locations

Overseen By Mariana Figueiro, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Psychotropics

Disqualifiers: Brain disease, Organ failure, Hypertension, Diabetes, others

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 9

Duration: 37 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests how a special light treatment, known as Light Therapy or Phototherapy, might improve sleep and memory for people with mild memory issues, such as mild cognitive impairment or early Alzheimer's, who live at home. The trial examines whether bright, circadian-friendly lights during the day can aid sleep and memory. It also evaluates how this light treatment affects caregivers' sleep, mood, and daily life. Individuals with sleep difficulties and mild memory problems might be suitable candidates. As an unphased trial, this study offers a unique opportunity to explore innovative treatments that could enhance quality of life.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have had recent changes in psychotropic medications (within 14 days), you may not be eligible to participate.

What prior data suggests that this lighting intervention is safe for individuals with mild cognitive impairment?

Research has shown that light therapy, which involves using light treatments, is generally safe and well-tolerated by people with dementia. Studies have found that these treatments can help improve thinking and memory. For example, a study that combined results from several other studies found that light therapy significantly enhanced cognitive abilities in dementia patients without causing major side effects.

Another study highlighted that a specific type of light treatment, called photobiomodulation therapy, is safe, non-invasive, and doesn't produce heat, making it comfortable for patients. Additionally, a small initial study found that bright light therapy improved thinking, memory, and behavior in older adults without causing serious side effects.

Overall, research suggests that light therapy is safe for people with mild cognitive impairment and dementia. While no treatment is completely without risk, light therapy appears to be well-tolerated and helpful for improving memory and mood. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the lighting intervention for mild cognitive impairment because it offers a unique approach by targeting the body's circadian system. Unlike standard treatments that often rely on medications, this innovative method uses specific light spectra and intensity to stimulate the circadian rhythm, potentially improving cognitive function. This non-invasive technique not only provides flexibility in how the light is delivered but also aims to enhance daytime alertness and sleep quality, offering a fresh perspective on managing cognitive decline without pharmacological side effects.

What evidence suggests that this lighting intervention is effective for mild cognitive impairment?

Research shows that light therapy can significantly aid people with dementia by enhancing their cognitive abilities. Studies have found that this therapy improves sleep, clarity of thought, and mood, while also reducing behavioral issues. One small study discovered that bright light therapy surpassed normal lighting in enhancing cognition and reducing behavioral problems in older adults. Participants reported better sleep, reduced anxiety, and fewer mood swings after using light therapy. In this trial, participants will receive either an active lighting intervention designed to stimulate the circadian system or a control lighting intervention with low levels of warm light. These findings suggest that light therapy could benefit individuals with mild memory problems and early-stage Alzheimer's disease. ^{1 3 4 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 people living at home with mild cognitive impairment or early Alzheimer's, who have sleep issues and a caregiver willing to assist. They should score 17-24 on the MoCA test and 0.5-9.0 on the CDR-SOB scale.

Inclusion Criteria

I have trouble sleeping, confirmed by tests.

You are interested in volunteering for the study.

I have mild memory loss or mild Alzheimer's with specific test scores.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a long-term light treatment intervention to improve sleep and cognition

37 weeks

Visits at baseline and the end of weeks 9, 17, 25, and 37

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lighting Intervention

Trial Overview The study tests how a special lighting setup in participants' homes might affect their sleep quality and memory over time. It also looks at any changes in caregivers' sleep, cognition, depression, and life satisfaction.

How Is the Trial Designed?

Group I: Active Lighting intervention Active Control 1 Intervention

The active lighting intervention 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, the intervention will allow us to: (1) use a light source that will stimulate the circadian system and (2) provide the participants with options as to how the light treatment will be delivered

Group II: Control Lighting Intervention Placebo Group 1 Intervention

The control lighting intervention will consist of low levels of a warm light source designed not to impact the circadian system.

Lighting Intervention is already approved in United States, European Union for the following indications:

Approved in United States as Light Therapy for:

• Mild Cognitive Impairment
• Alzheimer's Disease
• Sleep Disturbances
• Depression

Approved in European Union as Phototherapy for:

• Dementia
• Alzheimer's Disease
• Sleep Disturbances
• Behavioral and Psychological Symptoms of Dementia (BPSD)

Who Is Running the Clinical Trial?

Icahn School of Medicine at Mount Sinai

Lead Sponsor

Trials

933

Recruited

579,000+

National Institute on Aging (NIA)

Collaborator

Trials

1,841

Recruited

28,150,000+

Rutgers University

Collaborator

Trials

127

Recruited

2,814,000+

Published Research Related to This Trial

Nonpharmacological treatments, particularly behavioral interventions, exercise, and diet, show potential in alleviating behavioral symptoms and improving cognitive speed and executive functioning in individuals with mild cognitive impairment (MCI).

However, the current evidence is limited due to small sample sizes, lack of rigorous study designs, and short follow-up periods, highlighting the need for more comprehensive research to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonpharmacological therapies for behavioral and cognitive symptoms of mild cognitive impairment. Hahn, EA., Andel, R.[2016]

Non-pharmacological cognitive interventions for mild cognitive impairment (MCI) have shown positive effects on both objective and subjective outcomes, with benefits lasting from 1 month to 5 years based on a review of 32 clinical trials.

These interventions not only improved specific trained tasks but also indicated potential changes in brain imaging and transfer effects, suggesting broader cognitive benefits, although future studies need larger sample sizes and longer follow-up periods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy of Cognitive Intervention Programs for Mild Cognitive Impairment: A Systematic Review. Hong, YJ., Jang, EH., Hwang, J., et al.[2019]

In a pilot study involving 68 elderly participants with mild cognitive impairment, art therapy significantly improved neurocognitive functions compared to a control group, with benefits observed at both 3 and 9 months after the intervention.

No adverse effects were reported from the interventions, suggesting that art therapy is a safe psychosocial approach to enhance cognitive function in older adults with cognitive decline.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Art therapy is associated with sustained improvement in cognitive function in the elderly with mild neurocognitive disorder: findings from a pilot randomized controlled trial for art therapy and music reminiscence activity versus usual care. Mahendran, R., Gandhi, M., Moorakonda, RB., et al.[2019]

In a preliminary study involving older adults with mild cognitive impairment (MCI), a nurse-led computerized cognitive training (CCT) program showed significant improvements in immediate recall and language skills compared to an occupational therapist-led group.

The study suggests that training nurses to implement CCT could be an effective strategy for enhancing cognitive function in older adults with MCI, highlighting the potential for nurses to play a key role in cognitive rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nurse-Led Computerized Cognitive Training for Mild Cognitive Impairment: A Preliminary Study. Oh, MW., Ki, YJ., Jeon, BH., et al.[2021]

Home and community-based interventions for individuals with mild cognitive impairment or early dementia can improve physical and executive function, particularly when they include visual/written elements, technology-based training, and caregiver support.

The review identified 18 studies from 2007 to 2020, highlighting that effective interventions often involved simulating daily living activities and using both objective and subjective measures of cognitive function, but noted a lack of diversity in participant demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home/community-based interventions to improve function in persons with mild cognitive impairment/early dementia. Jenkins, E., Koirala, B., Rodney, T., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10176000/

Phototherapy improves cognitive function in dementia Our systematic review and meta‐analysis showed that phototherapy significantly improved cognitive function in patients with dementia.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1064748123005171

The Effects of Light Therapy on Sleep, Depression ... This meta-analysis demonstrates that light therapy is effective in improving sleep, cognition, and decreasing depression and neuropsychiatric behaviors for PLWD ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06618807

NCT06618807 | Infrared Light for Memory Loss in Mild ... Photobiomodulation (PBM) therapy also called low-level laser (or light) therapy (LLLT) is a safe, non-invasive, non-thermal (no significant heat is generated) ...

4. frontiersin.org frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2021.782160/full

Pilot Study of the Effects of Bright Ambient Therapy on ... In this pilot study, bright light therapy was more effective than general lighting at improving BPSD and cognitive function among older adults ...

5. alzheimers.org.uk alzheimers.org.uk/about-dementia/treatments/alternative-therapies/light-therapy-and-dementia

Light therapy and dementia Following the study, the participants reported increased cognitive function, better sleep, fewer angry bursts, less anxiety and less wandering. A further study ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9284896/

Phototherapy for Cognitive Function in Patients With Dementia In this meta-analysis, phototherapy interventions were associated with cognitive improvement in patients with dementia. NIR LEDs and lasers had ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224025511

Bright light therapy for agitation in dementia: a randomized ... Results: There was limited evidence of reduction in agitation in people on active treatment, sleep was improved and a suggestion of greater efficacy in the ...