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

NCT ID: NCT03933696

Last Updated: 2025-09-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2025-05-31

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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Type2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Tailored Lighting Intervention

Intervention Type: DEVICE

Lighting Intervention either Active or Placebo

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.

Group Type: PLACEBO_COMPARATOR

Tailored Lighting Intervention

Intervention Type: DEVICE

Lighting Intervention either Active or Placebo

Interventions

Tailored Lighting Intervention

Lighting Intervention either Active or Placebo

Intervention Type: DEVICE

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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Mariana Figueiro

Professor, Population Health Science and Policy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mariana G Figueiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Rutgers University

New Brunswick, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Other Identifiers

GCO 17-2685-0002

Identifier Type: -

Identifier Source: org_study_id