Clinical trial NCT05596994: 7T MRI for Light Therapy in Patients With Mild Cognitive Impairment and Mild AD
Official title: Use of 7T Multimodal Imaging to Detect Brain Changes Associated With Light Therapy in Persons With Mild Cognitive Impairment and Mild Alzheimer's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2022-10-27
Enrollment: 18
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

Detailed description: Subjects will be enrolled in the study for 26 weeks. During the first week, subject will come in to Mount Sinai for a study visit to complete a few questionnaires about sleep and mood, complete several memory tests and have an MRI of their brain. These study visits will take about 2 hours to complete. During this week, subject will also be asked to wear a wrist actigraph and light meter for 7 days. The actigraph is similar in size to a watch and is used to record their activity and rest patterns, and the light meter measures the amount of light they are exposed to during the day. After the completion of this week, subject will have a light treatment installed in their home that will be in place for 10 weeks. During the last week of the light treatment, subject will again come into Mount Sinai and repeat the questionnaires, memory tests and MRI, and wear the actigraph and light meter. After a 4-week break, subject will again come into Mount Sinai for a third study visit and complete the same questionnaires, memory tests, and MRI, and wear the actigraph and light meter. After this week, subject will have a different type of light treatment installed in their home and left in place for 10 weeks. During the last week of the light treatment, subject will come into Mount Sinai for the final study visit and complete the questionnaires, memory tests and MRI, and wear the actigraph and light meter for 7 days. There are no costs associated with participation, but subject will receive monetary compensation for each of the 4 study visits.

Eligibility 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

Primary outcomes:
measure: Changes in Brian Volumes
timeFrame: Baseline and post-therapy at Week 26
measure: Changes in Perivascular Space Density
timeFrame: Baseline and post-therapy at Week 26
Secondary outcomes:
measure: Changes in Structural connectivity as measured by dMRI
timeFrame: Baseline and post-therapy at Week 26
measure: Changes in Functional connectivity as measured by fMRI
timeFrame: Baseline and post-therapy at Week 26
measure: Percentage of Time Spent in Bed Sleeping
timeFrame: 7 days/week for 26 weeks
measure: Pittsburgh Sleep Quality Index (PSQI) Score
timeFrame: Baseline and every 4 weeks for duration of the study
measure: Circadian Stimulus (CS) values using the Daysimeter
timeFrame: During waking hours for 26 weeks
measure: Changes in Montreal Cognitive Assessment (MoCA) Score
timeFrame: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
measure: Changes Geriatric Depression Scale (GDS) Score
timeFrame: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
measure: Changes in Dementia Quality of Life Instrument (DQoL) Score
timeFrame: Baseline and at the end of each intervention period (each intervention period is 10 weeks)
Other outcomes:
Locations:
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Priti Balchandani, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Mariana Figueiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: