Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Mild Cognitive Impairment
In brief
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 facts
- Study ID
- NCT05016219
- Run by
- Icahn School of Medicine at Mount Sinai
- People needed
- 120
- Starts
- 2023-08-22
- Expected to finish
- 2027-07-31
- Last updated by the study team
- 2026-05-29
Who can join
Age: 55 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Light and Health Research Center — Menands, New York, United States (enrolling)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)
Full record on ClinicalTrials.gov
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