Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Cognition using the Montreal Cognitive Assessment (MoCA)
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Active Intervention plus Active Rhythm
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.
Intervention: Circadian-Effective Light (Device)
Active Intervention plus Active Rhythm
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.
Intervention: Rhythmic Light (Device)
Active Light plus Placebo Rhythm
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.
Intervention: Circadian-Effective Light (Device)
Active Light plus Placebo Rhythm
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.
Intervention: Placebo Rhythmic Light (Device)
Placebo Light plus Active Rhythm
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.
Intervention: Rhythmic Light (Device)
Placebo Light plus Active Rhythm
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.
Intervention: Placebo Light (Device)
Placebo Light plus Placebo Rhythm
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.
Intervention: Placebo Light (Device)
Placebo Light plus Placebo Rhythm
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.
Intervention: Placebo Rhythmic Light (Device)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Cognition using a word pair associates task(at the end of week 14.)
- Cognition using an implicit priming task(at the end of week 14.)
- Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale(at the end of week 14.)
- Sleep Quantity using Actigraphy(week 14)
- Urine Melatonin Biomarker(at the end of week 9.)
- Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)(at the end of week 14.)
- Quality of Life using the Dementia Quality of Life Instrument(at the end of week 14.)
- Cognition using a working memory task(at the end of week 14)
- Light Exposure using a Daysimeter(week 14.)
- Cognition using a working memory task(baseline)
- Cognition using a working memory task(at the end of week 9)
- Cognition using a word pair associates task(baseline)
- Cognition using a word pair associates task(at the end of week 9)
- Cognition using an implicit priming task(baseline)
- Cognition using an implicit priming task(at the end of week 9)
- Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale(baseline)
- Cognition using the Alzheimer's Disease Assessment Scale - Cognitive Subscale(at the end of week 9)
- Urine Melatonin Biomarker(baseline)
- Light Exposure using a Daysimeter(baseline)
- Light Exposure using a Daysimeter(week 9)
- Sleep Quantity using Actigraphy(baseline)
- Sleep Quantity using Actigraphy(week 9)
- Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)(baseline)
- Sleep Quality using the Pittsburgh Sleep Quality Index (PSQI)(at the end of week 9)
- Quality of Life using the Dementia Quality of Life Instrument(baseline)
- Quality of Life using the Dementia Quality of Life Instrument(at the end of week 9)
Investigators
Mariana Figueiro
Professor, Population Health Science and Policy
Icahn School of Medicine at Mount Sinai