Mild Cognitive ImpairmentNCT05411822
Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment
A study testing Lighting Intervention Blue light and Lighting Intervention Green light in people with Mild Cognitive Impairment and Alzheimer Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Lighting Intervention Blue light and Lighting Intervention Green light
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2021to 31 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- mild cognitive impairment
- age matched healthy control
- macular pigment density either < 0.3 or > 0.5
Who cannot join
- extensive brain vascular disease
- Parkinson's disease
- bipolar disorder
- seasonal depression
- diabetes
- high blood pressure
Show all 13Show fewer
- obstructing cataracts
- macular degeneration
- diabetic retinopathy
- use of melatonin supplements
- use of beta blockers
- use of sleep medications
- use of antidepressant medication
Trial locations and contacts
1 site in 1 country.
United States1 site
Light and Health Research Center at Mount Sinai
Menands, New York, 12204
About this study
Official title: Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment and Alzheimer's Disease
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Lighting Intervention Blue light, Lighting Intervention Green light, Dim-light control condition
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lighting Intervention Blue lightDevice
Custom made lighting fixture that will deliver the blue lighting intervention. Blue light (λmax = 451 nm) on axis and off axis.
Lighting Intervention Green lightDevice
Custom made lighting fixture that will deliver the green lighting intervention. Green light (λmax = 522 nm) on and off axis
Dim-light control conditionOther
(< 5 lux at the eye) for 30 min
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Lighting Intervention Blue light; Device: Lighting Intervention Green light; Other: Dim-light control condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start14 Jun 2021
- Primary completion31 May 2024
- Study completion31 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Mariana Figueiro, Icahn School of Medicine at Mount Sinai
- Investigators
- Mariana Figueiro, PhD, Principal investigator, Icahn School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05411822
- Sponsor's protocol ID
- GCO 21-0400
- Other IDs
- R21AG070713
- Status last verified
- Jun 2025
- First submitted
- 2 Jun 2022
- Last updated
- 24 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment and Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05411822
- Acronym / sponsor ID
- GCO 21-0400
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 14 Jun 2021 (actual)
- Primary completion
- 31 May 2024 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 9 Jun 2022 (actual)
- Results
- Posted 24 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants with Mild Cognitive Impairment | Experimental | Device: Lighting Intervention Blue light, Device: Lighting Intervention Green light, Other: Dim-light control conditionEvery 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. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- mild cognitive impairment
- age matched healthy control
- macular pigment density either < 0.3 or > 0.5
Key exclusion criteria (13 listed)
- extensive brain vascular disease
- Parkinson's disease
- bipolar disorder
- seasonal depression
- diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lighting Intervention Blue lightCustom made lighting fixture that will deliver the blue lighting intervention. Blue light (λmax = 451 nm) on axis and off axis. | Device | Participants with Mild Cognitive Impairment |
| Lighting Intervention Green lightCustom made lighting fixture that will deliver the green lighting intervention. Green light (λmax = 522 nm) on and off axis | Device | Participants with Mild Cognitive Impairment |
| Dim-light control condition(< 5 lux at the eye) for 30 min | Other | Participants with Mild Cognitive Impairment |
Primary outcome
Melatonin Levels
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana Figueiro, PhD principal investigator
Icahn School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lighting Intervention Blue light and Lighting Intervention Green light in people with Mild Cognitive Impairment and Alzheimer Disease, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Melatonin Levels (time frame: post-intervention (60 minutes) on each night of intervention (one night a week for 5 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2025.