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

NCT03933696 | Completed

• 1 other identifier: GCO 17-2685-0002
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

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).

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Sleep disturbance using actigraphy

  Done at Baseline, week 13, 25 and 48

• Light measurements

  Done at Baseline, week 13, 25 and 48

• Melatonin Levels

  One morning during Baseline, week 13, 25 and 48

• Sleep disturbance

  Done at Baseline, week 13, 25 and 48

• Depression

  Done at Baseline, week 13, 25 and 48

Study Arms (2)

Active Lighting Intervention

ACTIVE COMPARATOR

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

Placebo Lighting Intervention

PLACEBO COMPARATOR

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

Interventions

Tailored Lighting Intervention DEVICE

Lighting Intervention either Active or Placebo

Active Lighting Intervention; Placebo Lighting Intervention

Eligibility Criteria

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

You may qualify if:

• Mild cognitive impairment
• Mild Alzheimer's Disease
• Sleep Disturbance
• Live at home

You may not qualify if:

• Blindness
• insulin-dependent diabetes patients
• macular degeneration
• severe sleep apnea

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (2)

Rutgers University

New Brunswick, New Jersey, 08854, United States

Location

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Mariana G Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants will be randomly assigned to receive the active or placebo lighting condition

Study Record Dates

• First Submitted: April 25, 2019
• First Posted: May 1, 2019
• Study Start: January 2, 2019
• Primary Completion: May 31, 2025
• Study Completion: May 31, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)