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

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ClinicalTrials.gov Identifier: NCT03777722
Recruitment Status : Recruiting
First Posted : December 17, 2018
Last Update Posted : December 19, 2018
Sponsor:
Collaborator:
Icahn School of Medicine at Mount Sinai
Information provided by (Responsible Party):
Mariana G Figueiro, 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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Diabetes Mellitus, Type 2 Device: Tailored Lighting Intervention Not Applicable

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.

Aim 2: Test if a TLI that promotes entrainment can improve sleep disturbances, inflammation, insulin sensitivity (Si) and glucose disposal (Sg) and cognition in patients with MCI and mild ADRD and sleep disturbances. Using a single-arm, between-subjects, placebo-controlled study the investigators will investigate if long-term (6-month) exposure to TLI improves glucose homeostasis and insulin sensitivity in patients with MCI and mild AD who suffer from sleep disturbance and are living at home. Participants will be recruited from the Mount Sinai AD research center (ADRC) and randomized to receive the TLI (or comparison control treatment) at home. The investigators hypothesize that, compared to the comparison light, a TLI will increase entrainment, improve sleep, reduce depression, reduce inflammation, improve metabolic control, increase insulin sensitivity, and reduce susceptibility to T2DM and metabolic disease during and after the completion of the 6-month intervention.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Crossover placebo controlled design
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : October 31, 2023


Arm Intervention/treatment
Experimental: Active Intervention then Placebo
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.
Device: Tailored Lighting Intervention
Lighting Intervention

Experimental: Placebo Intervention then Active
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.
Device: Tailored Lighting Intervention
Lighting Intervention




Primary Outcome Measures :
  1. Change in Glucose tolerance [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    change in glucose tolerance from baseline will be assessed using an oral glucose tolerance test

  2. change in depression [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of nine or more points indicates depression.

  3. Change in sleep disturbance [ Time Frame: once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26 ]
    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.



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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03777722


Contacts
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Contact: Mariana Figueiro, PhD 518-687-7142 Figuem@rpi.edu

Locations
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United States, New York
Rensselaer Polytechnic Institute Recruiting
Troy, New York, United States, 12180
Contact: Barbara Plitnick, RN    518-687-7166    plitnb@rpi.edu   
Sponsors and Collaborators
Rensselaer Polytechnic Institute
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Mariana Figueiro, PhD Rensselaer Polytechnic Institute

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Responsible Party: Mariana G Figueiro, Professor, Rensselaer Polytechnic Institute
ClinicalTrials.gov Identifier: NCT03777722     History of Changes
Other Study ID Numbers: 1R01AG060716-01-NOA
1R01AG060716-01 ( U.S. NIH Grant/Contract )
First Posted: December 17, 2018    Key Record Dates
Last Update Posted: December 19, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Metabolic Syndrome
Diabetes Mellitus
Alzheimer Disease
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Insulin Resistance
Hyperinsulinism