An interventional study of Lighting Intervention Blue light and Lighting Intervention Green light in Mild Cognitive Impairment and Alzheimer Disease, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 55 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-24.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.
Eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. There will be 5 study session and each one will last for 90 minutes and will be separated by one week. Subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.
3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.
This study's enrollment of 36 is below the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.
Browse Cognitive Dysfunction studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion Criteria:
Every participant experienced all 5 conditions: Blue light (λmax = 451 nm) on axis and off axis. Green light (λmax = 522 nm) on and off axis Dim-light control condition (\< 5 lux at the eye) for 30 min each narrowband source will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye.
Device: Lighting Intervention Blue light · Device: Lighting Intervention Green light · Other: Dim-light control condition
Custom made lighting fixture that will deliver the blue lighting intervention. Blue light (λmax = 451 nm) on axis and off axis.
Custom made lighting fixture that will deliver the green lighting intervention. Green light (λmax = 522 nm) on and off axis
(\< 5 lux at the eye) for 30 min
Melatonin Levels
Saliva samples collected for melatonin levels for the different conditions. Blue light (λmax = 451 nm) on axis and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Green light (λmax = 522 nm) on and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Dim-light control condition: (\< 5 lux at the eye) for 30 min
Time frame: post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)
| Milestone | Participants With Mild Cognitive Impairment | Matched Control |
|---|---|---|
| Started | 17 | 19 |
| Completed | 15 | 18 |
| Not completed | 2 | 1 |
| Withdrew: Withdrawal by subject | 2 | 1 |
Saliva samples collected for melatonin levels for the different conditions. Blue light (λmax = 451 nm) on axis and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Green light (λmax = 522 nm) on and off axis: for each narrowband source, designated on-axis or off-axis, will have distinct lighting distribution patterns but calibrated to deliver the same targeted levels of circadian light (CLA) and circadian stimulus (CS) at the eye. Dim-light control condition: (\< 5 lux at the eye) for 30 min
| pg/mL | Mild Cognitive Impairment | Healthy Control |
|---|---|---|
| Blue light (λmax = 451 nm) on axis | 0.89 ± 0.49 | 0.84 ± 0.51 |
| Blue light (λmax = 451 nm) off axis | 0.9 ± 0.46 | 0.68 ± 0.21 |
| Green light (λmax = 522 nm) on axis | 0.73 ± 0.14 | 0.73 ± 0.3 |
| Green light (λmax = 522 nm) off axis | 0.82 ± 0.39 | 0.79 ± 0.24 |
| Dim Light | 1.53 ± 0.7 | 1.27 ± 0.3 |
Collected over 60 minutes of intervention over 1 day per week for 5 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mild Cognitive Impairment - Lighting Intervention Blue - On Axis | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Mild Cognitive Impairment - Blue - Off Axis | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Mild Cognitive Impairment - Lighting Intervention Green - On Axis | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Mild Cognitive Impairment - Green - Off Axis | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Mild Cognitive Impairment - Dim Light | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Healthy Control - Lighting Intervention Blue - On Axis | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Healthy Control - Blue - Off Axis | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Health Control - Lighting Intervention Green - On Axis | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Healthy Control - Green - Off Axis | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Health Control Dim Light | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Age, Continuous(years) | Participants With Mild Cognitive Impairment | Healthy Age-Matched Control | Total |
|---|---|---|---|
| Mean | 59.1 ± 7.4 | 58.7 ± 7.6 | 58.8 ± 7.4 |
| Sex: Female, Male(Participants) | Participants With Mild Cognitive Impairment | Healthy Age-Matched Control | Total |
|---|---|---|---|
| Female | 15 | 13 | 28 |
| Male | 2 | 6 | 8 |
| Race and Ethnicity Not Collected(Participants) | Participants With Mild Cognitive Impairment | Healthy Age-Matched Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
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Icahn School of Medicine at Mount Sinai