Light therapy for patients with Alzheimer's disease
Phase 2 - The Use of Rhythmic Light Therapy to Entrain Gamma Oscillations and the Circadian System in Patients With Alzheimer's Disease
This study is testing if special blue light therapy can help improve sleep and thinking skills in people with mild Alzheimer's disease and mild cognitive impairment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 55 Years and up |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 2 sites (Menands, New York and 1 other locations) |
| Trial ID | NCT05016219 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of rhythmic light therapy on patients with mild cognitive impairment and mild Alzheimer's disease. Participants will be randomly assigned to one of four groups to experience different lighting conditions, including both active and placebo light treatments. The intervention involves exposure to narrowband blue light designed to stimulate circadian rhythms, compared to a placebo red light. Assessments will be conducted weekly over an 8-week period to evaluate cognitive function and sleep quality.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with mild cognitive impairment or mild Alzheimer's disease who also experience sleep disturbances.
Not a fit: Patients taking sleep medications or those with severe sleep disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could improve cognitive function and sleep quality in patients with Alzheimer's disease.
How similar studies have performed: Other studies have shown promise with light therapy approaches for cognitive and sleep-related issues, suggesting potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must be diagnosed with mild cognitive impairment or mild Alzheimer's disease, as defined by a Montreal Cognitive Assessment score between 17 and 25; * Have sleep disturbance indicated by a score \>5 on the Pittsburgh Sleep Quality Index * Participants must reside in their homes, independent living, or assisted living facilities Exclusion Criteria: * Participants taking sleep medication * Residence in a skilled nursing facility or long-term care * Obstructing cataracts, macular degeneration, and blindness * Severe sleep apnea or restless leg syndrome * History of severe epilepsy
Where this trial is running
Menands, New York and 1 other locations
- Light and Health Research Center — Menands, New York, United States (Recruiting)
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Mariana Figueiro, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Barbara Plitnick, BSN
- Email: barbara.plitnick@mountsinai.org
- Phone: 518-242-4603
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.