Light Therapy for Mild Cognitive Impairment

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

73 Participants Needed

Trial Summary

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.

How is light therapy different from other treatments for mild cognitive impairment?

Light therapy is unique because it uses exposure to bright light to potentially improve cognitive function, unlike other treatments that often focus on cognitive exercises or psychosocial interventions. This approach is non-invasive and does not involve medication, making it a novel option for those with mild cognitive impairment. ^{1 2 3 4 5}

What is the purpose of this trial?

To investigate the impact of a long-term light treatment intervention on sleep physiology and memory in mild cognitively impaired and mild Alzheimer's disease patients living at home. The goal is also to measure the impact of the lighting intervention on caregivers' sleep, cognition, depression, and quality of life.

Research Team

Mariana Figueiro, PhD

Principal Investigator

Icahn School of Medicine at Mount Sinai

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

References

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

The Efficacy of Cognitive Intervention Programs for Mild Cognitive Impairment: A Systematic Review. [2019]

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

Home/community-based interventions to improve function in persons with mild cognitive impairment/early dementia. [2022]

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

Nurse-Led Computerized Cognitive Training for Mild Cognitive Impairment: A Preliminary Study. [2021]

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

Nonpharmacological therapies for behavioral and cognitive symptoms of mild cognitive impairment. [2016]

5. England 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. [2019]