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Light Therapy
Light Therapy for Alzheimer's Disease
N/A
Recruiting
Led By Mariana G 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
Mild Alzheimer's Disease
Mild cognitive impairment
Must not have
Insulin-dependent diabetes
Macular degeneration
Timeline
Screening 3 weeks
Treatment Varies
Follow Up done at baseline, week 13, 25 and 48
Summary
This trial will study the long-term effects of a light treatment on cognition, sleep and metabolism in patients with MCI or mild ADRD.
Who is the study for?
This trial is for people with mild cognitive impairment or early Alzheimer's who have trouble sleeping and live at home. It's not suitable for those who are blind, need insulin for diabetes, have severe vision loss from macular degeneration, or serious sleep apnea.
What is being tested?
The study is looking into how a special lighting setup in the home can affect thinking abilities, sleep quality, and body metabolism over time in individuals with mild memory problems or early Alzheimer's disease.
What are the potential side effects?
Since this trial involves a lighting intervention, side effects may be minimal but could include discomfort due to changes in light exposure which might affect sleep patterns or eye strain.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with mild Alzheimer's Disease.
Select...
I have mild memory or thinking problems.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I use insulin to manage my diabetes.
Select...
I have macular degeneration.
Select...
I have been diagnosed with severe sleep apnea.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ done at baseline, week 13, 25 and 48
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~done at baseline, week 13, 25 and 48
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Cognition
Depression
Metabolic control
+1 moreSecondary study objectives
Light measurements
Melatonin Levels
Sleep disturbance using actigraphy
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Active Lighting InterventionActive Control1 Intervention
The TLI 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, TLI will allow us to: (a) use a light source that will stimulate the circadian system, and (b) provide the participants with options as to how the light treatment will be delivered. The investigators will deliver at least 300-400 lux at the eye of the bluish-white light during the day (CS of 0.4 or greater).
The lighting intervention will be in place for 24 weeks
Group II: Placebo Lighting InterventionPlacebo Group1 Intervention
The placebo condition light source will be a warm yellow - white (2700 - 3000 K) source providing 50 -100 lux at the eye. The lighting intervention will be in place for 24 weeks.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
904 Previous Clinical Trials
541,928 Total Patients Enrolled
Mariana G Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
2 Previous Clinical Trials
91 Total Patients Enrolled
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