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NCT05411822

Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Completed NA Results posted Last updated 24 June 2025
What this trial tests

NA trial testing Lighting Intervention Blue light in Mild Cognitive Impairment in 36 participants. Completed in 31 May 2024.

Timeline
14 June 2021
Primary endpoint
31 May 2024
31 May 2024

Quick facts

Lead sponsorIcahn School of Medicine at Mount Sinai
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment36
Start date14 June 2021
Primary completion31 May 2024
Estimated completion31 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Icahn School of Medicine at Mount Sinai

Who can join

55 and older, any sex, with Mild Cognitive Impairment or Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Melatonin Levels Primary · 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 sti

Blue light (λmax = 451 nm) on axis
GroupValue95% CI
Mild Cognitive Impairment0.89± 0.49
Healthy Control0.84± 0.51
Blue light (λmax = 451 nm) off axis
GroupValue95% CI
Mild Cognitive Impairment0.9± 0.46
Healthy Control0.68± 0.21
Green light (λmax = 522 nm) on axis
GroupValue95% CI
Mild Cognitive Impairment0.73± 0.14
Healthy Control0.73± 0.3
Green light (λmax = 522 nm) off axis
GroupValue95% CI
Mild Cognitive Impairment0.82± 0.39
Healthy Control0.79± 0.24
Dim Light
GroupValue95% CI
Mild Cognitive Impairment1.53± 0.7
Healthy Control1.27± 0.3

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Melatonin in Alzheimer's Disease: Literature Review and Therapeutic Trials.
    Steinbach MJ, Denburg NL. · · 2024 · cited 13× · PMID 39422936 · DOI 10.3233/jad-230760

Verify or expand the search:

Other recruiting trials for Mild Cognitive Impairment

Currently open trials in the same condition.

Other Icahn School of Medicine at Mount Sinai trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05411822.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing