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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 14
Awards & highlights
Study Summary
This trial will test the effects of two different types of light on the circadian system. One light will have a rhythmic flicker and the other will have a random flicker.
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.Check my eligibility
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.See study design
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 belowSelect...
I have mild cognitive issues or mild Alzheimer's, confirmed by a specific test score.
Select...
I live at home or in a facility that helps with daily activities.
Select...
I have trouble sleeping, as shown by my sleep test score.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 14
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 14
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cognition using the Montreal Cognitive Assessment (MoCA)
Secondary outcome measures
Cognition using a word pair associates task
Cognition using a working memory task
Cognition using an implicit priming task
+6 moreTrial 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
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 III: Active Light plus Placebo 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 IV: Placebo Light plus Placebo RhythmPlacebo Group2 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.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
860 Previous Clinical Trials
524,356 Total Patients Enrolled
Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
9 Previous Clinical Trials
674 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe sleep apnea or restless leg syndrome.I do not have severe eye conditions like obstructing cataracts, macular degeneration, or blindness.I have mild cognitive issues or mild Alzheimer's, confirmed by a specific test score.I live at home or in a facility that helps with daily activities.I have trouble sleeping, as shown by my sleep test score.I am currently taking medication to help me sleep.I have a history of severe epilepsy.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Light plus Active Rhythm
- Group 2: Placebo Light plus Placebo Rhythm
- Group 3: Active Intervention plus Active Rhythm
- Group 4: Active Light plus Placebo Rhythm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are patients currently eligible to participate in this research endeavor?
"According to clinicaltrials.gov, the trial posted on January 1st 2023 is not searching for patients at this point in time. The last update of this listing was made June 14th 2022. However, there are other 982 trials actively recruiting participants currently."
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