Light and the Effect on Metabolic Syndrome and Alzheimer's Disease

NCT03777722 | Completed

• 1 other identifier: GCO 17-2685
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 3

Brief Summary

This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment and treating metabolic disease and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have the potential to provide important insights into the link between AD/ADRD and type 2 diabetes (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. If positive results are observed, the potential also exists to transform the manner in which homes, assisted living facilities, and nursing homes are lighted by delivering a simple, practical, non-pharmacological intervention to promote entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in controlled environments (i.e., assisted living facilities and nursing homes), will investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control, compared to a control, circadian-inactive light.

Conditions

Alzheimer Disease; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Change in Glucose tolerance

  change in glucose tolerance from baseline will be assessed using an oral glucose tolerance test

  once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26

Secondary Outcomes (4)

• Sleep Efficiency using actigraphy

  7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26

• Light exposure using the Daysimeter

  7 days during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26

• Change in sleep disturbance

  once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26

• Change in depression

  once during weeks 1 (baseline), 5, 9, 18 (second baseline), 22, and 26

Study Arms (2)

Aim 1: Active Intervention then Placebo

EXPERIMENTAL

Tailored Lighting intervention (TLI). The active 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. The active lighting intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the placebo control intervention for 8 weeks.

Device: Tailored Lighting Intervention

Aim 1: Placebo Intervention then Active

EXPERIMENTAL

The placebo lighting intervention is designed to have no effect on the circadian system. The control intervention will be in place for 8 weeks. Following an 8 week washout period, the participants will see the active tailored lighting intervention for 8 weeks.

Device: Tailored Lighting Intervention

Interventions

Tailored Lighting Intervention DEVICE

Lighting Intervention - active or placebo

Aim 1: Active Intervention then Placebo; Aim 1: Placebo Intervention then Active

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of mild to moderate Alzheimer's disease or related dementia,
• sleep disturbance as determined by a score ≥ 5 on the PSQI

You may not qualify if:

• insulin-dependent diabetes,
• urinary incontinence
• obstructing cataracts
• macular degeneration
• blindness
• severe sleep apnea or
• restless leg syndrome (RLS)

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Rutgers University: collaborator

Study Sites (3)

Rutgers University

New Brunswick, New Jersey, 08854, United States

Location

Icahn School of Medicine at Mount Sinai

Albany, New York, 12204, United States

Location

Icahn School of Medicine

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Alzheimer Disease; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Mariana Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Population Health Science and Policy

Model Details: Crossover placebo controlled design

Study Record Dates

• First Submitted: December 12, 2018
• First Posted: December 17, 2018
• Study Start: November 19, 2018
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 12, 2025

Record last verified: 2025-09

Locations

US (3)