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).
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
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
25
Lighting Intervention either Active or Placebo
Rutgers University
New Brunswick, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Metabolic control
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
Sleep disturbance using actigraphy
Actigraphs will be worn for 7 days during assessment weeks to measure sleep
Time frame: Done at Baseline, week 13, 25 and 48
Light measurements
Light measurements will be collected using the Daysimeter for 7 days.
Time frame: Done at Baseline, week 13, 25 and 48
Melatonin Levels
First morning urine will be collected and assayed for melatonin levels
Time frame: One morning during Baseline, week 13, 25 and 48
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.
Time frame: Done at Baseline, week 13, 25 and 48
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.
Time frame: Done at Baseline, week 13, 25 and 48
Cognition
Changes in cognition will be assessed by use of the Alzheimer's Disease Assessment Scale- Cognitive Sub scale (ADAS-Cog). Scores range from 0 to 70 and a higher score signifies a greater degree of cognitive impairment.
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Time frame: Done at Baseline, week 13, 25 and 48