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

Not Applicable

Recruiting

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.

Recruitment & Eligibility

Inclusion Criteria

Exclusion Criteria

Arm && Interventions

Group	Intervention	Description
Placebo Lighting Intervention	Tailored 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.
Active Lighting Intervention	Tailored 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

Primary Outcome Measures

Name	Time	Method
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.
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.
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

Name	Time	Method
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

Locations (2): Rutgers University
🇺🇸
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
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New York, New York, United States