NCT05016219Recruiting
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
Source: ClinicalTrials.gov · Last updated 29 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- First submitted
- 12 Aug 2021
- Start date
- 22 Aug 2023
- Primary completion date
- 31 Mar 2027
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Alzheimer disease
- NCT number
- NCT05016219
What you commit to
- Study type: Interventional
- Planned participants: 120
- From 22 Aug 2023 to the primary completion date, 31 Mar 2027
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participants taking sleep medication
Other illness
- Severe sleep apnea or restless leg syndrome
- History of severe epilepsy
Other
- Residence in a skilled nursing facility or long-term care
- Obstructing cataracts, macular degeneration, and blindness
Who the study is looking for
- 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
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Light and Health Research Center Coordinator of this site? Confirm its status | Menands | United States | Recruiting |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.