Using light therapy to improve sleep and memory in patients with mild cognitive impairment and Alzheimer's disease
Use of 7T Multimodal Imaging to Detect Brain Changes Associated With Light Therapy in Persons With Mild Cognitive Impairment and Mild Alzheimer's Disease
NA · Icahn School of Medicine at Mount Sinai · NCT05596994
This study is testing whether light therapy can help improve sleep and memory in people with mild cognitive impairment and Alzheimer's disease.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 18 (estimated) |
| Ages | 50 Years to 85 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai (other) |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT05596994 on ClinicalTrials.gov |
What this trial studies
This research investigates the effects of light treatment on sleep, memory, and brain function in individuals with mild cognitive impairment (MCI) and Alzheimer's disease. Participants will undergo a series of assessments, including questionnaires, memory tests, and MRI scans, over a 26-week period. They will receive two different light treatments installed in their homes for 10 weeks each, with monitoring of their activity and light exposure. The study aims to understand how light can influence circadian rhythms and improve cognitive functions in affected patients.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 50 and older with amnestic mild cognitive impairment or mild Alzheimer's disease who experience circadian sleep disturbances.
Not a fit: Patients with other brain diseases that fully explain their dementia or those residing in skilled nursing facilities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance sleep quality and cognitive function in patients with mild cognitive impairment and Alzheimer's disease.
How similar studies have performed: While the specific approach of using light therapy for this purpose is novel, similar studies exploring light's effects on circadian rhythms and cognitive function have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * the patients must have undergone PET scans to measure amyloid protein accumulation within the past year * Those taking antidepressants will be included, but type of medicine and dosage intake will be monitored. * 50 years and older * Eligible participants will be amnestic mild cognitive impairment (MCI) or mild Alzheimer's disease (AD) patients with circadian sleep disturbances who reside in their homes, independent living, or assisted living facilities. * confirmed amyloid beta positive from an existing ADRC cohort with PET scan (age: 50-85 yrs, 40% M, 60% F; falling between 0.5-4.0 and 4.5-9.0 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SOB) Exclusion Criteria: * Those taking sleep medication will be not included * Presence of another brain disease that fully explains the dementia (extensive brain vascular disease, Parkinson's disease, dementia with Lewy bodies, traumatic brain injury, or multiple sclerosis) * residence in a skilled nursing facility or long-term care * indication for psychiatric hospitalization or acute suicidality in the opinion of the physician * recent changes in psychotropics (14 days) * major organ failure (e.g., kidney failure) * uncontrolled generalized disorders such as hypertension or diabetes * obstructing cataracts, macular degeneration, and blindness o Those who have undergone cataract surgery and received an intraocular lens coated with ultraviolet- and blue-blocking filters (400-440/440-500 nm) will also be excluded * severe sleep apnea: o Apnea will be screened for using the Sleep Apnea scale of the Sleep Disorders Questionnaire (SA-SDQ), a 12-item scale yielding scores between 0 and 60.3. The study will use a score of 29 as a cutoff for men (sensitivity 75%, specificity 65% for sleep apnea), and a cutoff of 26 for women (sensitivity 80%, specificity 67%). * restless leg syndrome (RLS): o RLS will be screened for using the International Restless Legs Scale (IRLS), a 10-item scale that yields scores between 0 and 40.4 The study will use a cutoff of greater than or equal to 11 (indicating the presence of symptoms that are at least moderate) as a positive screen for RLS * history of: * severe photosensitivity dermatitis * severe progressive retinal disease (e.g., macular degeneration), or; * a permanently dilated pupil (e.g., after certain types of cataract surgery) * 7T MRI specific exclusions including presence of metallic or biomedical implants (patients can be enrolled at the discretion of the study team and site MRI technicians) and claustrophobia
Where this trial is running
New York, New York
- Icahn School of Medicine at Mount Sinai — New York, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Priti Balchandani, PhD — Icahn School of Medicine at Mount Sinai
- Study coordinator: Yijuan Zhu
- Email: yijuan.zhu@mssm.edu
- Phone: (929) 317-2790
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.
Conditions: Mild Cognitive Impairment, Alzheimer's Disease