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

Mount Sinai Health System

Status: Completed

Conditions: Alzheimer Disease; Type2 Diabetes; Mild Cognitive Impairment

Treatments: Device: Tailored Lighting Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03933696

GCO 17-2685-0002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 55+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups, including a placebo group

Active Lighting Intervention

Active Comparator group

Description:

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

Treatment:

Device: Tailored Lighting Intervention

Placebo Lighting Intervention

Placebo Comparator group

Description:

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.

Treatment:

Device: Tailored Lighting Intervention