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Behavioural Intervention

Light Therapy for Alzheimer's Disease

N/A

Waitlist Available

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

Diagnosis of Alzheimer's disease or related dementia with a Montreal Cognitive Assessment score less than 25

Sleep disturbance with a Pittsburgh Sleep Quality Index score of 5 or higher

Must not have

Obstructing cataracts

Untreated moderate to severe sleep apnea

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to week 36

Summary

This trial aims to study how a personalized lighting intervention can affect sleep, thinking abilities, daily routines, mood, and behavior in people with Alzheimer's disease. They will enroll 100 participants in a study

Who is the study for?

This trial is for individuals with Alzheimer's Disease or Mild Cognitive Impairment. Participants will be involved in a study for 6 months, where they'll experience different lighting conditions to see how it affects their sleep, cognition, and mood.

What is being tested?

The study tests the effects of Tailored Lighting Intervention (TLI) versus placebo lighting on patients' circadian systems. It aims to understand if specific light exposure can improve sleep and cognitive functions in Alzheimer's patients.

What are the potential side effects?

Since this trial involves lighting interventions, there are minimal expected side effects. However, changes in light could potentially affect sleep patterns or mood temporarily.

Eligibility Criteria

Inclusion Criteria

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

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I have Alzheimer's or similar dementia with a MoCA score below 25.

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I have trouble sleeping, scoring 5 or more on a sleep quality test.

Exclusion Criteria

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

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I have cataracts that block my vision.

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I have moderate to severe sleep apnea that hasn't been treated.

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I have severe restless leg syndrome.

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I have severe vision loss due to macular degeneration.

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I do not have extensive brain vascular disease, traumatic brain injury, multiple sclerosis, or Parkinson's Disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to week 36

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to week 36

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to week 36 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in Sleep Disturbance using the Pittsburgh Sleep Quality Index (PSQI)

Secondary study objectives

Agitation using the Cohen-Mansfield Agitation Inventory (CMAI)

Cognitive status Using the Montreal Cognitive Assessment (MOCA)

Depression using the Cornell Scale for Depression in Dementia (CSDD)

+2 more

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Active Lighting InterventionActive Control1 Intervention

Combining spectrum and light level, the active TLI will allow the researchers to use a light source that will stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.

Group II: Control Lighting InterventionPlacebo Group1 Intervention

The control TLI will allow the researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.

0 / 7Eligibility criteria met