Mild Cognitive ImpairmentNCT05016219
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
A study testing Circadian-Effective Light and Rhythmic Light in people with Mild Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 2 sites in United States.
Trial summary
Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light [RL]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the… Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Circadian-Effective Light and Rhythmic Light
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesUnited States
- Study dates
- 22 Aug 2023to 31 Jul 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;
- Have sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index
- Participants must reside in their homes, independent living, or assisted living facilities
Who cannot join
- Participants taking sleep medication
- Residence in a skilled nursing facility or long-term care
- Obstructing cataracts, macular degeneration, and blindness
- Severe sleep apnea or restless leg syndrome
- History of severe epilepsy
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Light and Health Research Center
Menands, New York, 12204
Barbara Plitnick, BS, 518-242-4603, Barbara.Plitnick@mountsinai.org
- Recruiting
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
Mariana Figueiro, PhD, 518-366-9306, Mariana.Figueiro@mountsinai.org
About this study
Official title: Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light [RL]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.
Read the detailed description
The tailored lighting intervention used to promote circadian entrainment will provide high circadian stimulation during the day produced by narrowband blue light peaking at 470 nanometers (nm). A comparison lighting intervention (i.e., placebo lighting), a narrowband red light peaking at 630 nm, will be used as a control. Both the red and the blue light devices will also provide either the 40 hertz (Hz) flicker (RL) or the random flicker (placebo RL). For the random flicker (placebo RL), the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Circadian-Effective Light, Rhythmic Light, Placebo Light, Placebo Rhythmic Light
- Keywords
- Light Treatment, Circadian Rhythms, Gamma Wave Entrainment, Rhythmic Light, Sleep, Cognition
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Circadian-Effective LightDevice
Also called Active Light
Narrowband blue light
Rhythmic LightDevice
40 hertz (Hz) flicker
Placebo LightDevice
Narrowband red light
Placebo Rhythmic LightDevice
Random flicker for placebo rhythmic effect
| Study group | Role | What they receive |
|---|---|---|
| Active Intervention plus Active Rhythm | Active comparator | The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. Receives: Device: Circadian-Effective Light; Device: Rhythmic Light |
| Active Light plus Placebo Rhythm | Active comparator | The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. Receives: Device: Circadian-Effective Light; Device: Placebo Rhythmic Light |
| Placebo Light plus Active Rhythm | Active comparator | The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. Receives: Device: Rhythmic Light; Device: Placebo Light |
| Placebo Light plus Placebo Rhythm | Placebo comparator | The device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. Receives: Device: Placebo Light; Device: Placebo Rhythmic Light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Measured: baseline
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Measured: at the end of week 9
Cognition using the Montreal Cognitive Assessment (MoCA)
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Measured: at the end of week 14
Secondary outcomes (26)
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Measured: baseline
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Measured: at the end of week 9
Cognition using a working memory task
Participants view a serial visual display of letters and math problems. They are asked to hold the letters in memory while simultaneously determining if the simple math problems are correct (e.g., 7+5=13). Math performance is measured in percent correct and verbal performance is assessed by calculating Accuracy and Reaction Time (RT).
Measured: at the end of week 14
Cognition using a word pair associates task
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Measured: baseline
Cognition using a word pair associates task
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Measured: at the end of week 9
Cognition using a word pair associates task
Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.
Measured: at the end of week 14.
Cognition using an implicit priming task
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Measured: baseline
Cognition using an implicit priming task
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Measured: at the end of week 9
Cognition using an implicit priming task
Participants will be presented with simple pictures of objects and animals. Following a break, the participant will then be asked to identify a larger set of pictures as soon as he/she is able to do so as the pictures clarify over time; some of these test pictures were shown previously and some are new.
Measured: at the end of week 14.
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Measured: baseline
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Measured: at the end of week 9
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
This interview-style test assesses multiple cognitive domains such as memory, language, praxis, and orientation. The ADAS-Cog subscale is scored from 0-100. The full ADAS is scored from 0 to 150 by summing the number of errors made on each task so that higher scores indicate worse performance.
Measured: at the end of week 14.
Urine Melatonin Biomarker
Urine Melatonin Biomarker via urine collection
Measured: baseline
Urine Melatonin Biomarker
Urine Melatonin Biomarker via urine collection
Measured: at the end of week 9.
Light Exposure using a Daysimeter
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Measured: baseline
Light Exposure using a Daysimeter
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Measured: week 9
Light Exposure using a Daysimeter
The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.
Measured: week 14.
Sleep Quantity using Actigraphy
Sleep Quantity measured using Actigraphy
Measured: baseline
Sleep Quantity using Actigraphy
Sleep Quantity measured using Actigraphy
Measured: week 9
Sleep Quantity using Actigraphy
Sleep Quantity measured using Actigraphy
Measured: week 14
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Measured: baseline
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Measured: at the end of week 9
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index is a tool that can be used to measure sleep quality in clinical populations, composed of 19 items that generate 7 component scores (subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime dysfunction). Each item is weighted on a 0-3 interval scale. The global PSQI score is then calculated by totaling the seven component scores, providing an overall score ranging from 0 to 21, with higher score indicates worse sleep quality
Measured: at the end of week 14.
Quality of Life using the Dementia Quality of Life Instrument
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Measured: baseline
Quality of Life using the Dementia Quality of Life Instrument
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Measured: at the end of week 9
Quality of Life using the Dementia Quality of Life Instrument
The Dementia Quality of Life Instrument (DQoL) measures self-esteem, positive affect/humor, negative affect, feelings of belonging, and sense of aesthetics.The DQoL consists of 29 items, grouped into 5 subscales according to domain. Subjects are instructed to answer using a 5-point response scale (score from 1-5), either verbally or through use of a visual scale. Scores for each subscale are Self-esteem (4-20), Positive Affect/Humor (6-30), Absence of Negative Affect (11-55), Feelings of Belonging (3-15), Sense of Aesthetics (5-25); however, subscale scores are not summed for a total score. A higher number indicates greater quality of life.
Measured: at the end of week 14.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start22 Aug 2023
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Figueiro, Icahn School of Medicine at Mount Sinai
- Investigators
- Mariana Figueiro, PhD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016219
- Sponsor's protocol ID
- GCO 21-0378-02
- Status last verified
- May 2026
- First submitted
- 12 Aug 2021
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rea MS, Figueiro MG, Bullough JD, Bierman A. A model of phototransduction by the human circadian system. Brain Res Brain Res Rev. 2005 Dec 15;50(2):213-28. doi: 10.1016/j.brainresrev.2005.07.002. Epub 2005 Oct 7.
PubMed 16216333Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
PubMed 15817019Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
PubMed 6496779Figueiro MG, Hamner R, Bierman A, Rea MS. Comparisons of three practical field devices used to measure personal light exposures and activity levels. Light Res Technol. 2013 Aug;45(4):421-434. doi: 10.1177/1477153512450453.
PubMed 24443644Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8.
PubMed 1947597Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982 Jun;140:566-72. doi: 10.1192/bjp.140.6.566.
PubMed 7104545Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
PubMed 2748771McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
PubMed 6610841
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT05016219
- Acronym / sponsor ID
- GCO 21-0378-02
- Conditions
- Mild Cognitive Impairment
- Keywords
- Light Treatment, Circadian Rhythms, Gamma Wave Entrainment, Rhythmic Light, Sleep, Cognition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Study start
- 22 Aug 2023 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Participants will randomly be placed into one of four groups and experience one of the four following conditions: (1) a placebo light that provides a 40 hertz (Hz) flicker (rhythmic light [RL]); (2) a placebo light with a random flicker (placebo condition for rhythmic light); (3) a light source that will stimulate the circadian system and provides a 40 Hz flicker (RL); or (4) a light source that will stimulate the circadian system and provides a random flicker (placebo condition for rhythmic light). Following a baseline week, participants will experience his/her assigned lighting condition for two hours in the morning for 8 weeks. After a 4-week washout period, a final round of assessments will be obtained. Study assessments (except for the Pittsburgh Sleep Quality Index and Montreal Cognitive Assessment) will be collected at the end of each week, for a total of 8 assessments.
Detailed description
The tailored lighting intervention used to promote circadian entrainment will provide high circadian stimulation during the day produced by narrowband blue light peaking at 470 nanometers (nm). A comparison lighting intervention (i.e., placebo lighting), a narrowband red light peaking at 630 nm, will be used as a control. Both the red and the blue light devices will also provide either the 40 hertz (Hz) flicker (RL) or the random flicker (placebo RL). For the random flicker (placebo RL), the duty cycle will be delivered with a random interval determined by a Poisson process with an average interval of 40 hertz (Hz).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Active Intervention plus Active Rhythm | Active comparator | Device: Circadian-Effective Light, Device: Rhythmic LightThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. |
| Active Light plus Placebo Rhythm | Active comparator | Device: Circadian-Effective Light, Device: Placebo Rhythmic LightThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. |
| Placebo Light plus Active Rhythm | Active comparator | Device: Rhythmic Light, Device: Placebo LightThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. |
| Placebo Light plus Placebo Rhythm | Placebo comparator | Device: Placebo Light, Device: Placebo Rhythmic LightThe device will set on a tabletop in a room where the participant spends at least 2 hours in the morning. Using a timer, it will automatically turn on at preferred wakeup times (but no later than 09:00 am) chosen by the participant. Lights will remain on for at least 2 hours and participants will be asked to remain the space that lights are being applied for that period of time. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25;
- Have sleep disturbance indicated by a score >5 on the Pittsburgh Sleep Quality Index
- Participants must reside in their homes, independent living, or assisted living facilities
Key exclusion criteria (5 listed)
- Participants taking sleep medication
- Residence in a skilled nursing facility or long-term care
- Obstructing cataracts, macular degeneration, and blindness
- Severe sleep apnea or restless leg syndrome
- History of severe epilepsy
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 |
|---|---|---|
| Circadian-Effective LightAlso: Active LightNarrowband blue light | Device | Active Intervention plus Active Rhythm, Active Light plus Placebo Rhythm |
| Rhythmic Light40 hertz (Hz) flicker | Device | Active Intervention plus Active Rhythm, Placebo Light plus Active Rhythm |
| Placebo LightNarrowband red light | Device | Placebo Light plus Active Rhythm, Placebo Light plus Placebo Rhythm |
| Placebo Rhythmic LightRandom flicker for placebo rhythmic effect | Device | Active Light plus Placebo Rhythm, Placebo Light plus Placebo Rhythm |
Primary outcome
Cognition using the Montreal Cognitive Assessment (MoCA)
Time frame: baseline
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Cognition using the Montreal Cognitive Assessment (MoCA)
Time frame: at the end of week 9
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
Cognition using the Montreal Cognitive Assessment (MoCA)
Time frame: at the end of week 14
The Montreal Cognitive Assessment is a one-page, 30-point test that can be administered in 10 minutes. It assesses short-term memory, visuospatial abilities, executive functions, attention, concentration and working memory, language, and orientation to time and place. total score ranging from 0 to 30 units on a scale, with higher score indicating better cognitive global function.
26 secondary outcomes
Cognition using a working memory task
Time frame: baseline
Cognition using a working memory task
Time frame: at the end of week 9
Cognition using a working memory task
Time frame: at the end of week 14
Cognition using a word pair associates task
Time frame: baseline
Cognition using a word pair associates task
Time frame: at the end of week 9
Cognition using a word pair associates task
Time frame: at the end of week 14.
Cognition using an implicit priming task
Time frame: baseline
Cognition using an implicit priming task
Time frame: at the end of week 9
Cognition using an implicit priming task
Time frame: at the end of week 14.
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: baseline
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: at the end of week 9
Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
Time frame: at the end of week 14.
Urine Melatonin Biomarker
Time frame: baseline
Urine Melatonin Biomarker
Time frame: at the end of week 9.
Light Exposure using a Daysimeter
Time frame: baseline
Light Exposure using a Daysimeter
Time frame: week 9
Light Exposure using a Daysimeter
Time frame: week 14.
Sleep Quantity using Actigraphy
Time frame: baseline
Sleep Quantity using Actigraphy
Time frame: week 9
Sleep Quantity using Actigraphy
Time frame: week 14
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: baseline
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at the end of week 9
Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
Time frame: at the end of week 14.
Quality of Life using the Dementia Quality of Life Instrument
Time frame: baseline
Quality of Life using the Dementia Quality of Life Instrument
Time frame: at the end of week 9
Quality of Life using the Dementia Quality of Life Instrument
Time frame: at the end of week 14.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Background: PubMed 16216333Rea MS, Figueiro MG, Bullough JD, Bierman A. A model of phototransduction by the human circadian system. Brain Res Brain Res Rev. 2005 Dec 15;50(2):213-28. doi: 10.1016/j.brainresrev.2005.07.002. Epub 2005 Oct 7.
- Background: PubMed 15817019Nasreddine ZS, Phillips NA, Bedirian V, Charbonneau S, Whitehead V, Collin I, Cummings JL, Chertkow H. The Montreal Cognitive Assessment, MoCA: a brief screening tool for mild cognitive impairment. J Am Geriatr Soc. 2005 Apr;53(4):695-9. doi: 10.1111/j.1532-5415.2005.53221.x.
- Background: PubMed 6496779Rosen WG, Mohs RC, Davis KL. A new rating scale for Alzheimer's disease. Am J Psychiatry. 1984 Nov;141(11):1356-64. doi: 10.1176/ajp.141.11.1356.
- Background: PubMed 24443644Figueiro MG, Hamner R, Bierman A, Rea MS. Comparisons of three practical field devices used to measure personal light exposures and activity levels. Light Res Technol. 2013 Aug;45(4):421-434. doi: 10.1177/1477153512450453.
- Background: PubMed 1947597Buysse DJ, Reynolds CF 3rd, Monk TH, Hoch CC, Yeager AL, Kupfer DJ. Quantification of subjective sleep quality in healthy elderly men and women using the Pittsburgh Sleep Quality Index (PSQI). Sleep. 1991 Aug;14(4):331-8.
- Background: PubMed 7104545Hughes CP, Berg L, Danziger WL, Coben LA, Martin RL. A new clinical scale for the staging of dementia. Br J Psychiatry. 1982 Jun;140:566-72. doi: 10.1192/bjp.140.6.566.
- Background: PubMed 2748771Buysse DJ, Reynolds CF 3rd, Monk TH, Berman SR, Kupfer DJ. The Pittsburgh Sleep Quality Index: a new instrument for psychiatric practice and research. Psychiatry Res. 1989 May;28(2):193-213. doi: 10.1016/0165-1781(89)90047-4.
- Background: PubMed 6610841McKhann G, Drachman D, Folstein M, Katzman R, Price D, Stadlan EM. Clinical diagnosis of Alzheimer's disease: report of the NINCDS-ADRDA Work Group under the auspices of Department of Health and Human Services Task Force on Alzheimer's Disease. Neurology. 1984 Jul;34(7):939-44. doi: 10.1212/wnl.34.7.939.
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Community-based Screening for Alzheimer's Disease
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
RecruitingObservational study
InRAD Observational Study
Alzheimer's Disease(AD), Mild Cognitive Impairment (MCI)
Recruiting
Treating Insomnia in Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Insomnia
Recruiting
Telehealth-Adapted Compensatory Training and Intervention for Cognition
MCI, Mild Cognitive Impairment
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.
Mariana Figueiro, PhD principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Circadian-Effective Light and Rhythmic Light in people with Mild Cognitive Impairment, run by Icahn School of Medicine at Mount Sinai at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Barbara Plitnick, BSN (518-242-4603, barbara.plitnick@mountsinai.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cognition using the Montreal Cognitive Assessment (MoCA) (time frame: baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05016219, which also lists 8 linked publications.
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 29 May 2026.