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Light, Metabolic Syndrome and Alzheimer's Disease - Aim 2

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ClinicalTrials.gov Identifier: NCT03933696
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : March 15, 2023
Sponsor:
Information provided by (Responsible Party):
Mariana Figueiro, Icahn School of Medicine at Mount Sinai

Study Description
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Brief Summary:
To test the long term effect of a light treatment on cognition, sleep and metabolism in patients with Mild cognitive impairment (MCI) or mild Alzheimer's disease or related dementia (ADRD).

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Alzheimer Disease Type2 Diabetes Device: Tailored Lighting Intervention Not Applicable

Detailed Description:
Test if a tailored light intervention (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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants will be randomly assigned to receive the active or placebo lighting condition
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Active Lighting Intervention

The 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. Combining spectrum and light level, TLI will allow us to: (a) use a light source that will stimulate the circadian system, and (b) provide the participants with options as to how the light treatment will be delivered. The investigators will deliver at least 300-400 lux at the eye of the bluish-white light during the day (CS of 0.4 or greater).

The lighting intervention will be in place for 24 weeks

 Device: Tailored Lighting Intervention
Lighting Intervention either Active or Placebo
Placebo Comparator: Placebo Lighting Intervention
The placebo condition light source will be a warm yellow - white (2700 - 3000 K) source providing 50 -100 lux at the eye. The lighting intervention will be in place for 24 weeks.
 Device: Tailored Lighting Intervention
Lighting Intervention either Active or Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Sleep disturbance [ Time Frame: Done at Baseline, week 13, 25 and 48 ]
    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.

  2. Metabolic control [ Time Frame: Done at Baseline, week 13 and 25 ]
    Changes in glucose homeostasis and insulin sensitivity will be measured using the Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT).

  3. Depression [ Time Frame: Done at Baseline, week 13, 25 and 48 ]
    A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of nine or more points indicates depression.

  4. Cognition [ Time Frame: Done at Baseline, week 13, 25 and 48 ]
    Changes in cognition will be assessed by use of the Alzheimer's Disease Assessment Scale- Cognitive Sub scale (ADAS-Cog). All scores are summed and higher scores indicate higher severity of dementia.

  5. Cognition [ Time Frame: Done at Baseline, week 13, 25 and 48 ]
    Changes in cognition will be assessed using the mini mental state exam (MMSE). All scores are summed for a total score ranging from 0-30. Lower score indicates worsening dementia


Secondary Outcome Measures :
  1. Sleep disturbance using actigraphy [ Time Frame: Done at Baseline, week 13, 25 and 48 ]
    Actigraphs will be worn for 7 days during assessment weeks to measure sleep

  2. Light measurements [ Time Frame: Done at Baseline, week 13, 25 and 48 ]
    Light measurements will be collected using the Daysimeter for 7 days.

  3. Melatonin Levels [ Time Frame: One morning during Baseline, week 13, 25 and 48 ]
    First morning urine will be collected and assayed for melatonin levels


Eligibility Criteria
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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:

  • Mild cognitive impairment
  • Mild Alzheimer's Disease with an MMSE score of >19 or Clinical Dementia Rating of 0.5 or 1.
  • Sleep Disturbance
  • Live at home

Exclusion Criteria:

  • Blindness
  • insulin-dependent diabetes patients
  • macular degeneration
  • severe sleep apnea
Contacts and Locations
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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): NCT03933696


Contacts
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Contact: Christoph Buettner, MD, PhD 212-241-3425 christoph.buettner@mssm.edu
Contact: Barbara Plitnick, RN 518-276-7166 plitnb@rpi.edu

Locations
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United States, New Jersey
Rutgers University Recruiting
New Brunswick, New Jersey, United States, 08854
Contact: Christoph Buettner, MD       cb1116@rwjms.rutgers.edu   
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Contact: Christoph Buettner, MD, PhD    212-241-3425    christoph.buettner@mssm.edu   
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Investigators
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Principal Investigator: Mariana G Figueiro, PhD Icahn School of Medicine at Mount Sinai
More Information
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Responsible Party: Mariana Figueiro, Professor, Population Health Science and Policy, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03933696    
Other Study ID Numbers: GCO 17-2685-0002
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: March 15, 2023
Last Verified: March 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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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Alzheimer Disease
Metabolic Syndrome
Cognitive Dysfunction
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
 Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases