Actively Recruiting

Phase Not Applicable
Age: 55Years +
All Genders
NCT05016219

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

Led by Icahn School of Medicine at Mount Sinai · Updated on 2025-06-05

120

Participants Needed

2

Research Sites

205 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 55Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with mild cognitive impairment or mild Alzheimer's disease with a Montreal Cognitive Assessment score between 17 and 25
  • Have sleep disturbance indicated by a Pittsburgh Sleep Quality Index score greater than 5
  • Reside in their home, independent living, or assisted living facilities
Not Eligible

You will not qualify if you...

  • Taking sleep medication
  • Living in a skilled nursing facility or long-term care
  • Have obstructing cataracts, macular degeneration, or blindness
  • Have severe sleep apnea or restless leg syndrome
  • Have a history of severe epilepsy

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

Light and Health Research Center

Menands, New York, United States, 12204

Actively Recruiting

2

Icahn School of Medicine at Mount Sinai

New York, New York, United States, 10029

Actively Recruiting

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Research Team

B

Barbara Plitnick, BSN

CONTACT

M

Mariana Figueiro, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

4

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