Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Not Applicable

Completed

• Conditions: Alzheimer Disease; Mild Cognitive Impairment

• Registration Number: NCT05411822
• Lead Sponsor: Icahn School of Medicine at Mount Sinai

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-06-14
• Study First Submitted: 2022-06-02
• Study First Submitted QC: 2022-06-06
• Study First Posted: 2022-06-09
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Results First Submitted: 2025-04-15
• Status Verified: 2025-06
• Results First Submitted QC: 2025-06-05
• Last Update Submitted: 2025-06-05
• Results First Posted: 2025-06-24
• Last Update Posted: 2025-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• mild cognitive impairment
• age matched healthy control
• macular pigment density either < 0.3 or > 0.5

Exclusion Criteria

• extensive brain vascular disease
• Parkinson's disease
• bipolar disorder
• seasonal depression
• diabetes
• high blood pressure
• obstructing cataracts
• macular degeneration
• diabetic retinopathy
• use of melatonin supplements
• use of beta blockers
• use of sleep medications
• use of antidepressant medication

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Melatonin Levels	post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)	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

Trial Locations

Locations (1)

Light and Health Research Center at Mount Sinai; 🇺🇸 Menands, New York, United States