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出境医 / 临床实验 / Light, Metabolic Syndrome and Alzheimer's Disease - Aim 2

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

Study Description
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
Layout table for study information
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 : April 1, 2019
Estimated Primary Completion Date : August 31, 2023
Estimated Study Completion Date : August 31, 2023
Arms and Interventions
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
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

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
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE April 25, 2019
First Posted Date  ICMJE May 1, 2019
Last Update Posted Date June 8, 2021
Actual Study Start Date  ICMJE April 1, 2019
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • 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.
  • 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).
  • 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.
  • 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.
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2019)
  • 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
  • Light measurements [ Time Frame: Done at Baseline, week 13, 25 and 48 ]
    Light measurements will be collected using the Daysimeter for 7 days.
  • Melatonin Levels [ Time Frame: One morning during Baseline, week 13, 25 and 48 ]
    First morning urine will be collected and assayed for melatonin levels
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Light, Metabolic Syndrome and Alzheimer's Disease - Aim 2
Official Title  ICMJE Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
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).
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Type2 Diabetes
Intervention  ICMJE Device: Tailored Lighting Intervention
Lighting Intervention either Active or Placebo
Study Arms  ICMJE
  • 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

    Intervention: Device: Tailored Lighting Intervention
  • 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.
    Intervention: Device: Tailored Lighting Intervention
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 29, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 31, 2023
Estimated Primary Completion Date August 31, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Christoph Buettner, MD, PhD 212-241-3425 christoph.buettner@mssm.edu
Contact: Barbara Plitnick, RN 518-276-7166 plitnb@rpi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03933696
Other Study ID Numbers  ICMJE GCO 17-2685-0002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mariana Figueiro, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mariana G Figueiro, PhD Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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