Clinical trial NCT05016219: Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
Official title: Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Light Treatment
Circadian Rhythms
Gamma Wave Entrainment
Rhythmic Light
Sleep
Cognition
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2021-08-23
Enrollment: 120
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Cognition using the Montreal Cognitive Assessment (MoCA)
timeFrame: baseline
measure: Cognition using the Montreal Cognitive Assessment (MoCA)
timeFrame: at the end of week 9
measure: Cognition using the Montreal Cognitive Assessment (MoCA)
timeFrame: at the end of week 14
Secondary outcomes:
measure: Cognition using a working memory task
timeFrame: baseline
measure: Cognition using a working memory task
timeFrame: at the end of week 9
measure: Cognition using a working memory task
timeFrame: at the end of week 14
measure: Cognition using a word pair associates task
timeFrame: baseline
measure: Cognition using a word pair associates task
timeFrame: at the end of week 9
measure: Cognition using a word pair associates task
timeFrame: at the end of week 14.
measure: Cognition using an implicit priming task
timeFrame: baseline
measure: Cognition using an implicit priming task
timeFrame: at the end of week 9
measure: Cognition using an implicit priming task
timeFrame: at the end of week 14.
measure: Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
timeFrame: baseline
measure: Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
timeFrame: at the end of week 9
measure: Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale
timeFrame: at the end of week 14.
measure: Urine Melatonin Biomarker
timeFrame: baseline
measure: Urine Melatonin Biomarker
timeFrame: at the end of week 9.
measure: Light Exposure using a Daysimeter
timeFrame: baseline
measure: Light Exposure using a Daysimeter
timeFrame: week 9
measure: Light Exposure using a Daysimeter
timeFrame: week 14.
measure: Sleep Quantity using Actigraphy
timeFrame: baseline
measure: Sleep Quantity using Actigraphy
timeFrame: week 9
measure: Sleep Quantity using Actigraphy
timeFrame: week 14
measure: Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: baseline
measure: Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at the end of week 9
measure: Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: at the end of week 14.
measure: Quality of Life using the Dementia Quality of Life Instrument
timeFrame: baseline
measure: Quality of Life using the Dementia Quality of Life Instrument
timeFrame: at the end of week 9
measure: Quality of Life using the Dementia Quality of Life Instrument
timeFrame: at the end of week 14.
Other outcomes:
Locations:
city: Menands
country: United States
facility: Light and Health Research Center
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.