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

NCT05016219 | Recruiting

• 1 other identifier: GCO 21-0378-02
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief 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 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.

Conditions

Mild Cognitive Impairment

Keywords

Light Treatment; Circadian Rhythms; Gamma Wave Entrainment; Rhythmic Light; Sleep; Cognition

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  at the end of week 14

Secondary Outcomes (26)

• Cognition using a working memory task

  baseline

• Cognition using a working memory task

  at the end of week 9

• Cognition using a working memory task

  at the end of week 14

• Cognition using a word pair associates task

  baseline

• Cognition using a word pair associates task

  at the end of week 9

Study Arms (4)

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.

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.

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.

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.

Device: Placebo Light; Device: Placebo Rhythmic Light

Interventions

Circadian-Effective Light DEVICE

Narrowband blue light

Also known as: Active Light

Active Intervention plus Active Rhythm; Active Light plus Placebo Rhythm

Rhythmic Light DEVICE

40 hertz (Hz) flicker

Active Intervention plus Active Rhythm; Placebo Light plus Active Rhythm

Placebo Light DEVICE

Narrowband red light

Placebo Light plus Active Rhythm; Placebo Light plus Placebo Rhythm

Placebo Rhythmic Light DEVICE

Random flicker for placebo rhythmic effect

Active Light plus Placebo Rhythm; Placebo Light plus Placebo Rhythm

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Light and Health Research Center

Menands, New York, 12204, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Related Publications (8)

• 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.

  PMID: 16216333 BACKGROUND

• Nasreddine 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.

  PMID: 15817019 BACKGROUND

• Rosen 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.

  PMID: 6496779 BACKGROUND

• Figueiro 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.

  PMID: 24443644 BACKGROUND

• Buysse 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.

  PMID: 1947597 BACKGROUND

• Hughes 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.

  PMID: 7104545 BACKGROUND

• Buysse 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.

  PMID: 2748771 BACKGROUND

• McKhann 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.

  PMID: 6610841 BACKGROUND

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mariana Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Barbara Plitnick, BSN

CONTACT

518-242-4603; barbara.plitnick@mountsinai.org

Mariana Figueiro, PhD

CONTACT

518-366-9306; mariana.figueiro@mountsinai.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Population Health Science and Policy

Study Record Dates

• First Submitted: August 12, 2021
• First Posted: August 23, 2021
• Study Start: August 22, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2027
• Last Updated: June 5, 2025

Record last verified: 2025-06

Locations

US (2)