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

Primary Purpose

Mild Cognitive Impairment, Alzheimer Disease, Type2 Diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tailored Lighting Intervention
Sponsored by
Icahn School of Medicine at Mount Sinai
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rutgers UniversityRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active Lighting Intervention

Placebo Lighting Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.
Metabolic control
Changes in glucose homeostasis and insulin sensitivity will be measured using the Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT).
Depression
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
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
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

Sleep disturbance using actigraphy
Actigraphs will be worn for 7 days during assessment weeks to measure sleep
Light measurements
Light measurements will be collected using the Daysimeter for 7 days.
Melatonin Levels
First morning urine will be collected and assayed for melatonin levels

Full Information

First Posted
April 25, 2019
Last Updated
September 12, 2023
Sponsor
Icahn School of Medicine at Mount Sinai
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1. Study Identification

Unique Protocol Identification Number
NCT03933696
Brief Title
Light, Metabolic Syndrome and Alzheimer's Disease - Aim 2
Official Title
Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
May 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Icahn School of Medicine at Mount Sinai

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer Disease, Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomly assigned to receive the active or placebo lighting condition
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active Lighting Intervention
Arm Type
Active Comparator
Arm Description
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
Arm Title
Placebo Lighting Intervention
Arm Type
Placebo Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Tailored Lighting Intervention
Intervention Description
Lighting Intervention either Active or Placebo
Primary Outcome Measure Information:
Title
Sleep disturbance
Description
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.
Time Frame
Done at Baseline, week 13, 25 and 48
Title
Metabolic control
Description
Changes in glucose homeostasis and insulin sensitivity will be measured using the Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT).
Time Frame
Done at Baseline, week 13 and 25
Title
Depression
Description
A change in depression will be assessed using the Cornell Scale for Depression in Dementia. A score of nine or more points indicates depression.
Time Frame
Done at Baseline, week 13, 25 and 48
Title
Cognition
Description
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.
Time Frame
Done at Baseline, week 13, 25 and 48
Title
Cognition
Description
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
Time Frame
Done at Baseline, week 13, 25 and 48
Secondary Outcome Measure Information:
Title
Sleep disturbance using actigraphy
Description
Actigraphs will be worn for 7 days during assessment weeks to measure sleep
Time Frame
Done at Baseline, week 13, 25 and 48
Title
Light measurements
Description
Light measurements will be collected using the Daysimeter for 7 days.
Time Frame
Done at Baseline, week 13, 25 and 48
Title
Melatonin Levels
Description
First morning urine will be collected and assayed for melatonin levels
Time Frame
One morning during Baseline, week 13, 25 and 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Mild cognitive impairment Mild Alzheimer's Disease Sleep Disturbance Live at home Exclusion Criteria: Blindness insulin-dependent diabetes patients macular degeneration severe sleep apnea
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christoph Buettner, MD, PhD
Phone
212-241-3425
Email
cb1116@rwjms.rutgers.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Plitnick, RN
Phone
518-242-4603
Email
barbara.plitnick@mountsinai.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana G Figueiro, PhD
Organizational Affiliation
Icahn School of Medicine at Mount Sinai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Buettner, MD
Email
cb1116@rwjms.rutgers.edu
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christoph Buettner, MD, PhD
Phone
212-241-3425
Email
christoph.buettner@mssm.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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