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COMPLETED
NCT03777722
NA

Light and the Effect on Metabolic Syndrome and Alzheimer's Disease

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

Summary

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.

Official title: Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach

Key Details

Gender

All

Age Range

55 Years - Any

Study Type

INTERVENTIONAL

Enrollment

61

Start Date

2018-11-19

Completion Date

2025-05-31

Last Updated

2026-05-11

Healthy Volunteers

No

Interventions

DEVICE

Tailored Lighting Intervention

Lighting Intervention - active or placebo

Locations (3)

Rutgers University

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

Albany, New York, United States

Icahn School of Medicine

New York, New York, United States