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

Light, Metabolic Syndrome and Alzheimer's Disease: A Non-Pharmocological Approach

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).

Study Overview

• Status: Completed
• Conditions: Alzheimer Disease; Mild Cognitive Impairment; Type2 Diabetes
• Intervention / Treatment: Device: Tailored Lighting Intervention

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: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • New Brunswick, New Jersey, United States, 08854
      • Rutgers University
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolic control	Changes in glucose homeostasis and insulin sensitivity will be measured using the Frequently Sampled Intravenous Glucose Tolerance Test (FSIVGTT).	Done at Baseline, week 13 and 25

Secondary Outcome Measures

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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): May 31, 2025
• Study Completion (Actual): May 31, 2025

Study Registration Dates

• First Submitted: April 25, 2019
• First Submitted That Met QC Criteria: April 29, 2019
• First Posted (Actual): May 1, 2019

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 11, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Dementia; Tauopathies; Neurodegenerative Diseases; Cognitive Dysfunction; Alzheimer Disease
• Other Study ID Numbers: GCO 17-2685-0002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No