7T MRI for Light Therapy in Patients With Mild Cognitive Impairment and Mild AD

ID#: NCT05596994

Age: 50 - 85 years

Gender: All

Healthy Subjects: No

Study Phase: N/A

Recruitment Status: Recruiting

Start Date: November 01, 2022

End Date: April 01, 2024

Contact Information:
Yijuan Zhu
(929) 317-2790
Catherine Ma
(212) 824-8494
Summary: The purpose of this research study is to investigate the effect of a light treatment on sleep, memory and brain function. In people with mild cognitive impairment (MCI) and Alzheimer's disease, sleep-wake disturbance is evident in up to 60% of patients. This can be caused by disruption of circadian rhythms and may affect our health and well-being. Circadian rhythms are the natural cycle of physical, mental, and behavior changes that the body goes through in a 24-hour cycle. Circadian rhythms are mostly affected by light and darkness and are controlled by a small area in the middle of the brain. They can affect sleep, body temperature, hormones, appetite, and other body functions. The circadian system plays an important role in the body and can affect sleep and brain function. The results of the research would help develop light-delivery methods to improve sleep and memory in patients with mild cognitive impairment (MCI) and Alzheimer's disease who typically spend a significant amount of time indoors.

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