What is the mechanism of action of this treatment?

Common treatments for Mild Cognitive Impairment (MCI) often aim to enhance brain activity and regulate circadian rhythms. One such treatment is light therapy, including 40 Hz Flicker Light, which is believed to stimulate brain activity and improve circadian rhythm regulation. This therapy can potentially reduce amyloid-beta accumulation, a hallmark of Alzheimer's disease, and improve sleep patterns, which are often disrupted in MCI patients. By targeting these mechanisms, light therapy may help slow cognitive decline and improve overall quality of life for individuals with MCI.

What side effects are associated with this type of intervention?

The most common treatments for Mild Cognitive Impairment (MCI) that involve light therapy, such as 40 Hz Flicker Light, generally have minimal side effects. Studies on gamma sensory stimulation, which is similar to 40 Hz Flicker Light, have shown it to be well tolerated with high adherence to daily treatment. Reported side effects are rare but can include headaches and, in some cases, elevated liver function tests. Behavioral modifications and light therapy are low-risk interventions, with the primary side effect being potential relapse of symptoms if the therapy is discontinued.

What prior FDA approvals exist?

Currently, there are no FDA-approved medications specifically for the treatment of Mild Cognitive Impairment (MCI). However, treatments for Alzheimer's disease, such as cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine), are sometimes used off-label for MCI. The 40 Hz Flicker Light therapy, which is being studied for its potential effects on brain activity and circadian rhythm regulation, represents a novel non-pharmacological approach. This therapy aims to improve cognitive function and daily living activities by modulating neural oscillations and circadian rhythms, but it is still under investigation and not yet FDA-approved.

What other types of research exist?

Promising alternatives to 40 Hz Flicker Light for MCI patients include: 1) Morning light therapy using broad-spectrum white light, which can help realign circadian rhythms. 2) Timed melatonin supplementation to regulate sleep-wake cycles. 3) Behavioral modifications such as improved sleep hygiene and reduced evening light exposure. These alternatives have shown potential in improving circadian rhythm regulation and cognitive function.

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Behavioural Intervention

Light Therapy for Alzheimer's Disease

N/A

Recruiting

Led By Mariana Figueiro, PhD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25

Participants must reside in their homes, independent living, or assisted living facilities

Must not have

Severe sleep apnea or restless leg syndrome

Obstructing cataracts, macular degeneration, and blindness

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 14

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort from the flickering lights which could lead to headaches or eyestrain. There might also be changes in sleep patterns due to the stimulation of the circadian system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe sleep apnea or restless leg syndrome.

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

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I am currently taking medication to help me sleep.

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I have a history of severe epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 14

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 14

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 14 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Cognition using the Montreal Cognitive Assessment (MoCA)

Secondary study objectives

Cognition using a word pair associates task

Cognition using a working memory task

Cognition using an implicit priming task

+6 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: Placebo Light plus Active RhythmActive Control2 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 RhythmActive Control2 Interventions

Group III: Active Light plus Placebo RhythmActive Control2 Interventions

Group IV: Placebo Light plus Placebo RhythmPlacebo Group2 Interventions

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Mild Cognitive Impairment (MCI) often aim to enhance brain activity and regulate circadian rhythms. One such treatment is light therapy, including 40 Hz Flicker Light, which is believed to stimulate brain activity and improve circadian rhythm regulation. This therapy can potentially reduce amyloid-beta accumulation, a hallmark of Alzheimer's disease, and improve sleep patterns, which are often disrupted in MCI patients. By targeting these mechanisms, light therapy may help slow cognitive decline and improve overall quality of life for individuals with MCI.

Efficacy of intermittent exposure to bright light for treating maladaptation to night work on a counterclockwise shift work rotation.Effectiveness of evening phototherapy for insomnia is reduced by bright daytime light exposure.Dawn-dusk simulation light therapy of disturbed circadian rest-activity cycles in demented elderly.