RecruitingNot ApplicableNCT05016219

Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

120 participants

Start Date

Aug 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light \[RL\]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.


Eligibility

Min Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether rhythmic light therapy (flickering light at a specific frequency) can improve sleep and slow memory decline in people with mild cognitive impairment or early Alzheimer's disease. **You may be eligible if...** - You have been diagnosed with mild cognitive impairment or mild Alzheimer's disease (Montreal Cognitive Assessment score between 17 and 25) - You have sleep problems (scored above 5 on the Pittsburgh Sleep Quality Index) - You live in your own home, independent living, or an assisted living facility **You may NOT be eligible if...** - You are currently taking sleep medications - You live in a skilled nursing facility or long-term care home - You have eye conditions that could block or interfere with light exposure - You have a history of seizures or epilepsy triggered by light Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICECircadian-Effective Light

Narrowband blue light

DEVICERhythmic Light

40 hertz (Hz) flicker

DEVICEPlacebo Light

Narrowband red light

DEVICEPlacebo Rhythmic Light

Random flicker for placebo rhythmic effect


Locations(2)

Light and Health Research Center

Menands, New York, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

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NCT05016219


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