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

Part of paid clinical trials in Menands, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05016219
Status
Recruiting
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Conditions

  • Mild Cognitive Impairment

Eligibility Criteria

Sex
ALL
Age
55 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Circadian-Effective Light — DEVICE
    Narrowband blue light
  • Rhythmic Light — DEVICE
    40 hertz (Hz) flicker
  • Placebo Light — DEVICE
    Narrowband red light
  • Placebo Rhythmic Light — DEVICE
    Random flicker for placebo rhythmic effect

Study Details

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.

Key Dates

Start date
Aug 22, 2023
Status verified
May 2026
Primary completion
Mar 31, 2027
Completion
Jul 31, 2027

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 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.
  • Active Comparator: 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.
  • Active Comparator: 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.
  • Placebo Comparator: 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.

Primary Outcome Measure

Cognition using the Montreal Cognitive Assessment (MoCA) [ Time Frame: baseline ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Light and Health Research CenterMenandsNew York12204
Barbara Plitnick, BS
[email protected]
518-242-4603
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Mariana Figueiro, PhD
[email protected]
518-366-9306

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By research site
Light and Health Research Center· Menands, NYIcahn School of Medicine at Mount Sinai· New York, NY

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