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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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up during waking hours for 26 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial will investigate the effect of a light treatment on sleep, memory and brain function in people with MCI and Alzheimer's. Light treatment may improve sleep and memory in these patients.
Who is the study for?
This trial is for people aged 50 and older with mild cognitive impairment or mild Alzheimer's disease, who have sleep disturbances. They must have had a PET scan showing amyloid protein in the past year and not live in long-term care facilities. Excluded are those with severe eye conditions, recent cataract surgery with certain lenses, on sleep meds, at risk of psychiatric hospitalization, or with other brain diseases.
What is being tested?
The study tests whether light therapy can improve sleep and memory in patients by influencing their circadian rhythms—the body's natural 24-hour cycle affected by light. Participants will receive either the actual Lighting Intervention Therapy (LIT) or a sham version to compare effects.
What are the potential side effects?
Potential side effects may include discomfort from exposure to light therapy such as eyestrain or headache. Since this is non-invasive treatment, serious side effects are unlikely but could involve worsening of sleep issues due to changes in light exposure.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days/week for 26 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days/week for 26 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Changes in Brian Volumes
Changes in Perivascular Space Density
Secondary study objectives
Changes Geriatric Depression Scale (GDS) Score
Changes in Dementia Quality of Life Instrument (DQoL) Score
Changes in Functional connectivity as measured by fMRI
+5 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Light Intervention Therapy (LIT) then Sham LITActive Control2 Interventions
The LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT.
Group II: Sham LIT then Light Intervention TherapyActive Control2 Interventions
LIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm.
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Who is running the clinical trial?
Icahn School of Medicine at Mount SinaiLead Sponsor
903 Previous Clinical Trials
541,750 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,785 Previous Clinical Trials
28,184,718 Total Patients Enrolled
Mariana Figueiro, PhDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai
10 Previous Clinical Trials
857 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am between 50-85 years old, have a confirmed amyloid beta positive PET scan, and my dementia rating is between 0.5-9.0.I am not taking any sleep medication.I am 50 years old or older.I have not had cataract surgery with a UV and blue light-blocking lens implant.I haven't changed my mental health medications in the last 14 days.My dementia is not caused by another brain disease like Parkinson's or MS.I do not have major organ failure.I have moderate to severe symptoms of restless leg syndrome.I do not have severe eye conditions like obstructing cataracts, macular degeneration, or blindness.I have severe skin reactions to sunlight, advanced eye disease, or a permanently dilated pupil.I have mild memory loss or Alzheimer's with sleep issues and live at home or in a care facility.I am taking antidepressants and can provide details about them.I do not have uncontrolled conditions like high blood pressure or diabetes.
Research Study Groups:
This trial has the following groups:- Group 1: Light Intervention Therapy (LIT) then Sham LIT
- Group 2: Sham LIT then Light Intervention Therapy
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
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