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

Sponsor

Icahn School of Medicine at Mount Sinai (Other)

Overall Status

Recruiting

CT.gov ID

NCT03933696

Collaborator

(none)

Enrollment

Locations

Arms

55.9

Anticipated Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants will be randomly assigned to receive the active or placebo lighting conditionParticipants 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 :

Jan 2, 2019

Anticipated Primary Completion Date :

Aug 31, 2023

Anticipated Study Completion Date :

Aug 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

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

Sleep disturbance [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 [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 [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 [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 [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

Sleep disturbance using actigraphy [Done at Baseline, week 13, 25 and 48]
Actigraphs will be worn for 7 days during assessment weeks to measure sleep
Light measurements [Done at Baseline, week 13, 25 and 48]
Light measurements will be collected using the Daysimeter for 7 days.
Melatonin Levels [One morning during Baseline, week 13, 25 and 48]
First morning urine will be collected and assayed for melatonin levels

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rutgers University	New Brunswick	New Jersey	United States	08854
2	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

Icahn School of Medicine at Mount Sinai

Investigators

Principal Investigator: Mariana G Figueiro, PhD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

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

Last Update Posted:

Apr 26, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Alzheimer Disease

Metabolic Syndrome

Cognitive Dysfunction

Study Results

No Results Posted as of Apr 26, 2022