Light Therapy for Alzheimer's Disease

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen byMariana Figueiro, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Icahn School of Medicine at Mount Sinai

Must not be taking: Sleep medication, Melatonin

Disqualifiers: Brain vascular disease, Parkinson's, others

Trial Summary

What is the purpose of this trial?Investigate the long-term impact of amount and duration of Tailored Lighting Intervention (TLI) obtained from Aims 1 and 2 on sleep, cognition, circadian marker, mood, and behavior in AD/ADRD patients. For this single-arm, randomized, placebo-controlled study, the researchers plan to recruit 100 participants who will experience either the active TLI or the placebo for 6 months.

Eligibility Criteria

This trial is for individuals with Alzheimer's Disease or Mild Cognitive Impairment. Participants will be involved in a study for 6 months, where they'll experience different lighting conditions to see how it affects their sleep, cognition, and mood.

Inclusion Criteria

I have Alzheimer's or similar dementia with a MoCA score below 25.

I have trouble sleeping, scoring 5 or more on a sleep quality test.

Exclusion Criteria

I am taking oral melatonin.

I use medication to help me sleep.

I have cataracts that block my vision.

+5 more

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either the active Tailored Lighting Intervention (TLI) or placebo for 6 months

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Participant Groups

The study tests the effects of Tailored Lighting Intervention (TLI) versus placebo lighting on patients' circadian systems. It aims to understand if specific light exposure can improve sleep and cognitive functions in Alzheimer's patients.

2Treatment groups

Active Control

Placebo Group

Group I: Active Lighting InterventionActive Control1 Intervention

Combining spectrum and light level, the active TLI will allow the researchers to use a light source that will stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.

Group II: Control Lighting InterventionPlacebo Group1 Intervention

The control TLI will allow the researchers to use a light source that will not stimulate the circadian system and provide the participants with options as to how the light treatment will be delivered.