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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03933696
• Other study ID #: GCO 17-2685-0002
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2019
• Est. completion date: May 31, 2024

Study information

• Verified date: September 2023
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Christoph Buettner, MD, PhD
• Phone: 212-241-3425
• Email: cb1116[@]rwjms.rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Metabolic Syndrome
• Mild Cognitive Impairment
• Type2 Diabetes

Intervention

Device:
• Tailored Lighting Intervention
Lighting Intervention either Active or Placebo

Locations

Country	Name	City	State
United States	Rutgers University	New Brunswick	New Jersey
United States	Icahn School of Medicine at Mount Sinai	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	Cognition	Changes in cognition will be assessed by use of the Alzheimer's Disease Assessment Scale- Cognitive Sub scale (ADAS-Cog). All scores are summed and higher scores indicate higher severity of dementia.	Done at Baseline, week 13, 25 and 48
Primary	Cognition	Changes in cognition will be assessed using the mini mental state exam (MMSE). All scores are summed for a total score ranging from 0-30. Lower score indicates worsening dementia	Done at Baseline, week 13, 25 and 48
Secondary	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
Secondary	Light measurements	Light measurements will be collected using the Daysimeter for 7 days.	Done at Baseline, week 13, 25 and 48
Secondary	Melatonin Levels	First morning urine will be collected and assayed for melatonin levels	One morning during Baseline, week 13, 25 and 48