Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment

Alzheimer Disease Clinical Trial

Official title:

Understanding Circadian Responses to Light in Persons With Mild Cognitive Impairment and Alzheimer's Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05411822
• Other study ID #: GCO 21-0400
• Status: Recruiting
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: April 2025

Study information

• Verified date: March 2024
• Source: Icahn School of Medicine at Mount Sinai
• Contact: Barbara Plitnick, BSN
• Phone: 518 366-9306
• Email: barbara.plitnick[@]mountsinai.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this research study is to investigate the relationship between light, the thickness of the pigment at the back of your eye, melatonin levels, and memory. The study will investigate whether changing light distribution pattern from "on-axis"' (i.e., directed along the eye's visual axis to the fovea) to "off-axis" (i.e., directed on the periphery of the eye's visual axis) impact melatonin suppression in 24 mild cognitive impairment participants and 24 healthy, age-matched controls.

Description:

Eligible enrolled subjects will be exposed to 4 different lighting conditions in addition to one dark control condition. There will be 5 study session and each one will last for 90 minutes and will be separated by one week. Subjects will collect 3 saliva samples, each one 30 minutes apart for melatonin levels during each study session.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

Inclusion Criteria:

• mild cognitive impairment
• age matched healthy control
• macular pigment density either < 0.3 or > 0.5

Exclusion Criteria:

• extensive brain vascular disease
• Parkinson's disease
• bipolar disorder
• seasonal depression
• diabetes
• high blood pressure
• obstructing cataracts
• macular degeneration
• diabetic retinopathy
• use of melatonin supplements
• use of beta blockers
• use of sleep medications
• use of antidepressant medication

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Device:
• Lighting Intervention Blue light
Custom made lighting fixture that will deliver the blue lighting intervention
• Lighting Intervention Green light
Custom made lighting fixture that will deliver the green lighting intervention

Locations

Country	Name	City	State
United States	Light and Health Research Center at Mount Sinai	Menands	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	Change in melatonin levels	Saliva samples will be collected for melatonin analysis	one sample will be collected every 30 minutes during each 90 minute study session up to 5 weeks