NCT03777722Completed
Light and the Effect on Metabolic Syndrome and Alzheimer's Disease
Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment and treating metabolic disease and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have the potential to provide important insights into the link between AD/ADRD and type 2 diabetes (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. If positive results are observed, the potential also exists to transform the manner in which homes, assisted living facilities, and nursing homes are lighted by delivering a simple, practical, non-pharmacological intervention to promote entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in controlled environments (i.e., assisted living facilities and nursing homes), will investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control, compared to a control, circadian-inactive light.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 61 (actual)
- First submitted
- 12 Dec 2018
- Start date
- 19 Nov 2018
- Primary completion date
- 31 May 2025
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Diseases
- Alzheimer disease, Type 2 diabetes
- NCT number
- NCT03777722
What you commit to
- Study type: Interventional
- Participants enrolled: 61
- From 19 Nov 2018 to the primary completion date, 31 May 2025
- 3 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.
Other illness
- insulin-dependent diabetes,
- restless leg syndrome (RLS)
Other
- urinary incontinence
- obstructing cataracts
- macular degeneration
- blindness
- severe sleep apnea or
Who the study is looking for
- Diagnosis of mild to moderate Alzheimer's disease or related dementia,
- sleep disturbance as determined by a score ≥ 5 on the PSQI
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | Albany | United States | Unknown status |
| Rutgers University Coordinator of this site? Confirm its status | New Brunswick | United States | Unknown status |
| Icahn School of Medicine Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.