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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
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

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Icahn School of Medicine at Mount Sinai
Coordinator of this site? Confirm its status
AlbanyUnited StatesUnknown status
Rutgers University
Coordinator of this site? Confirm its status
New BrunswickUnited StatesUnknown status
Icahn School of Medicine
Coordinator of this site? Confirm its status
New YorkUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.