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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03777722
• Other study ID #: GCO 17-2685
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: April 30, 2025

Study information

• Verified date: February 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Barbara Plitnick, BSN
• Phone: 518-242-4603
• Email: barbara.plitnick[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Alzheimer's disease (AD) and type 2 diabetes (T2DM) pose linked, major threats to aging societies worldwide, but the relationship between these two diseases remains poorly understood. Hence, insulin resistance may account for the close epidemiological association between AD and T2DM. A major gap in the understanding of this association, however, is how brain insulin resistance develops in the context of AD. Studies show that circadian disruption impairs metabolic control and increases the risk for diabetes and obesity. Vice versa, disrupted sleep and depression are closely linked to impaired metabolic control and increased diabetes risk in the general population. Notably, AD is associated with circadian disruption, which may be amplified by exposure to irregular light-dark patterns or constant dim light. To what extent circadian disruption contributes to increased diabetes risk in AD remains unclear. Here, the investigator aims to test whether a novel tailored lighting intervention (TLI) designed to promote circadian entrainment in AD patients can improve metabolic control. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. Given the close association of sleep on metabolic control, these data support the hypothesis that light therapy that promotes entrainment can restore metabolic control in AD patients. Specifically, the investigator will test the efficacy of a practical, scientifically sophisticated 24-hour lighting system for increasing circadian entrainment in older adults with AD and related dementias (ADRD). The major goal is to demonstrate that a practical, effective, tailored, nonpharmacological intervention that promotes circadian entrainment can be used to improve sleep, reduce inflammation, and ameliorate glucose intolerance and insulin resistance in AD/ADRD patients. Aim 1: Test if a TLI that promotes entrainment can improve sleep, depression, inflammation, and glucose tolerance in patients with moderate to late stages ADRD. In a randomized, placebo-controlled, crossover study involving 60 ADRD patients who live in controlled environments, the investigators will investigate whether an 8-week exposure to a TLI designed to increase circadian entrainment (urinary melatonin and activity-rest patterns) will improve inflammation and glucose tolerance (oral glucose tolerance test), and reduce sleep disturbances (actigraphy, Pittsburgh Sleep Quality Index, PSQI) and depressive symptoms (Cornell Scale for Depression in Dementia, CSDD) compared to a control, circadian-inactive light.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• Diagnosis of mild to moderate Alzheimer's disease or related dementia,
• sleep disturbance as determined by a score = 5 on the PSQI

Exclusion Criteria:

• insulin-dependent diabetes,
• urinary incontinence
• obstructing cataracts
• macular degeneration
• blindness
• severe sleep apnea or
• restless leg syndrome (RLS)

Related Conditions & MeSH terms

• Alzheimer Disease
• Diabetes Mellitus, Type 2
• Metabolic Syndrome

Intervention

Device:
• Tailored Lighting Intervention
Lighting Intervention - active or placebo

Locations

Country	Name	City	State
United States	Icahn School of Medicine at Mount Sinai	Albany	New York
United States	Rutgers University	New Brunswick	New Jersey
United States	Icahn School of Medicine	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Rutgers University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Glucose tolerance	change in glucose tolerance from baseline will be assessed using an oral glucose tolerance test	once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Primary	Change in sleep disturbance	Change in sleep disturbance will be assessed using the Pittsburgh Sleep Quality Index. The sum of the 7 component scores yields a single global score. A person with a global score above 5 is considered to have sleep disturbances. A higher score indicates worsening sleep disturbance.	once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Primary	Change in depression	A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of twelve or more points indicates depression. A higher score indicates worsening depression.	once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Secondary	Sleep Efficiency using actigraphy	Actigraphs will be worn for 7 days during assessment weeks. Actigraphy will be used to calculate changes in sleep efficiency. A higher sleep efficiency indicates better sleep.	7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Secondary	Light exposure using the Daysimeter	Daysimeters will be worn for 7 days during assessment periods to measure the amount of circadian effective light delivered by the lighting intervention.	7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26