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

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

Sponsors

Lead Sponsor: Rensselaer Polytechnic Institute

Collaborator: Icahn School of Medicine at Mount Sinai

Source Rensselaer Polytechnic Institute
Brief 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.

Detailed 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.

Overall Status Recruiting
Start Date November 1, 2018
Completion Date October 31, 2023
Primary Completion Date December 31, 2022
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Change in Glucose tolerance once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Change in sleep disturbance once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Change in depression once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Secondary Outcome
Measure Time Frame
Sleep Efficiency using actigraphy 7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Light exposure using the Daysimeter 7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26
Enrollment 60
Condition
Intervention

Intervention Type: Device

Intervention Name: Tailored Lighting Intervention

Description: Lighting Intervention - active or placebo

Eligibility

Criteria:

Inclusion Criteria:

- Diagnosis of mild to moderate Alzheimer's disease or related dementia,

- type 2 diabetes

- 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)

Gender: All

Minimum Age: 55 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mariana Figueiro, PhD Principal Investigator Rensselaer Polytechnic Institute
Overall Contact

Last Name: Mariana Figueiro, PhD

Phone: 518-276-7142

Email: [email protected]

Location
Facility: Status: Contact: Rensselaer Polytechnic Institute Barbara Plitnick, RN 518-276-7166 [email protected]
Location Countries

United States

Verification Date

May 2019

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Rensselaer Polytechnic Institute

Investigator Full Name: Mariana G Figueiro

Investigator Title: Professor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Aim 1: Active Intervention then Placebo

Type: Experimental

Description: Tailored Lighting intervention (TLI). The active TLI will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 weeks.

Label: Aim 1: Placebo Intervention then Active

Type: Experimental

Description: The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.

Study Design Info

Allocation: Randomized

Intervention Model: Crossover Assignment

Intervention Model Description: Crossover placebo controlled design

Primary Purpose: Treatment

Masking: Triple (Participant, Care Provider, Outcomes Assessor)

Source: ClinicalTrials.gov