N/A
N=36
Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment
Mild Cognitive Impairment · Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT05411822 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Melatonin Levels — 0.89; 0.84; 0.9; 0.68 pg/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lighting Intervention Blue light (Device); Lighting Intervention Green light (Device); Dim-light control condition (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Melatonin Levels |
0.89; 0.84; 0.9; 0.68; 0.73; 0.73 | — |
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.
Eligibility Criteria
Inclusion Criteria
- mild cognitive impairment
- age matched healthy control
- macular pigment density either 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
Data sourced from ClinicalTrials.gov (NCT05411822). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.