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

Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease

Who can join

Ages 55 and older · All sexes

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

About the study

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.

What is being tested

• Circadian-Effective Light (device)
• Rhythmic Light (device)
• Placebo Light (device)
• Placebo Rhythmic Light (device)

Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 120 · Started: Aug 22, 2023

Contact the study team

• Barbara Plitnick, BSN · Phone: 518-242-4603
• Mariana Figueiro, PhD · Phone: 518-366-9306

Official record on ClinicalTrials.gov — NCT05016219

Locations in the U.S.

Conditions

• Mild Cognitive Impairment

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.