Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05016219

Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients

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.

Recruiting

Interested in participating?

Request Info

Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Light and Health Research Center, Menands, New York, United States

Loading trial locations.

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Circadian-Effective Light

Device

Narrowband blue light

Other names: Active Light

Rhythmic Light

Device

40 hertz (Hz) flicker

Placebo light

Device

Narrowband red light

Placebo Rhythmic Light

Device

Random flicker for placebo rhythmic effect

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Cognition using a working memory task

    Time frame: baseline

    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).

  2. Cognition using a working memory task

    Time frame: at the end of week 9

    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).

  3. Cognition using a working memory task

    Time frame: at the end of week 14

    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).

  4. Cognition using a word pair associates task

    Time frame: baseline

    Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.

  5. Cognition using a word pair associates task

    Time frame: at the end of week 9

    Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.

  6. Cognition using a word pair associates task

    Time frame: at the end of week 14.

    Participants are presented with 48 word-pairs in the evening. Recognition tests are assessed both immediately following the encoding session, and delayed during retrieval.

  7. Cognition using an implicit priming task

    Time frame: baseline

    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.

  8. Cognition using an implicit priming task

    Time frame: at the end of week 9

    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.

  9. Cognition using an implicit priming task

    Time frame: at the end of week 14.

    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.

  10. Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale

    Time frame: baseline

    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.

  11. Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale

    Time frame: at the end of week 9

    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.

  12. Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale

    Time frame: at the end of week 14.

    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.

  13. Urine Melatonin Biomarker

    Time frame: baseline

    Urine Melatonin Biomarker via urine collection

  14. Urine Melatonin Biomarker

    Time frame: at the end of week 9.

    Urine Melatonin Biomarker via urine collection

  15. Light Exposure using a Daysimeter

    Time frame: baseline

    The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.

  16. Light Exposure using a Daysimeter

    Time frame: week 9

    The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.

  17. Light Exposure using a Daysimeter

    Time frame: week 14.

    The Daysimeter will also be used to monitor the total amount of circadian light received by the participant during the study.

  18. Sleep Quantity using Actigraphy

    Time frame: baseline

    Sleep Quantity measured using Actigraphy

  19. Sleep Quantity using Actigraphy

    Time frame: week 9

    Sleep Quantity measured using Actigraphy

  20. Sleep Quantity using Actigraphy

    Time frame: week 14

    Sleep Quantity measured using Actigraphy

  21. Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: baseline

    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

  22. Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: at the end of week 9

    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

  23. Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)

    Time frame: at the end of week 14.

    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

  24. Quality of Life using the Dementia Quality of Life Instrument

    Time frame: baseline

    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.

  25. Quality of Life using the Dementia Quality of Life Instrument

    Time frame: at the end of week 9

    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.

  26. Quality of Life using the Dementia Quality of Life Instrument

    Time frame: at the end of week 14.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Plitnick, BSN

CONTACT

[email protected]

518-242-4603

Mariana Figueiro, PhD

CONTACT

[email protected]

518-366-9306

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2021
Registry last updated
May 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.