Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

NCT05411822 | Completed Results

• 2 other identifiers: GCO 21-0400R21AG070713
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• 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

  post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)

Study Arms (1)

Participants with Mild Cognitive Impairment

EXPERIMENTAL

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

Interventions

Lighting Intervention Blue light DEVICE

Custom made lighting fixture that will deliver the blue lighting intervention. Blue light (λmax = 451 nm) on axis and off axis.

Participants with Mild Cognitive Impairment

Lighting Intervention Green light DEVICE

Custom made lighting fixture that will deliver the green lighting intervention. Green light (λmax = 522 nm) on and off axis

Participants with Mild Cognitive Impairment

Dim-light control condition OTHER

(\< 5 lux at the eye) for 30 min

Participants with Mild Cognitive Impairment

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Light and Health Research Center at Mount Sinai

Menands, New York, 12204, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Results Point of Contact

• Title: Mariana Figueiro, PhD
• Organization: Icahn School of Medicine at Mount Sinai

Mariana.Figueiro@mountsinai.org

(518) 366-9306

Study Officials

• Mariana Figueiro, PhD

  Icahn School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 2, 2022
• First Posted: June 9, 2022
• Study Start: June 14, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: June 24, 2025
• Results First Posted: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)