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

NCT05596994 | Completed

• 2 other identifiers: GCO 21-0668R21AG076211
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

• Changes in Brian Volumes

  Volumes of structures associated with cognitive impairment and AD pathophysiology will be quantified from 7T imaging data. Hippocampal subfield volumes and amygdala subnuclei volumes will be computed. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.

  Baseline and post-therapy at Week 26

• Changes in Perivascular Space Density

  Perivascular spaces will be computed from structural scans using automated segmentation methods. The measures will be compared pre- and post-therapy to determine effect of LIT on the brain.

  Baseline and post-therapy at Week 26

Secondary Outcomes (8)

• Changes in Structural connectivity as measured by dMRI

  Baseline and post-therapy at Week 26

• Changes in Functional connectivity as measured by fMRI

  Baseline and post-therapy at Week 26

• Percentage of Time Spent in Bed Sleeping

  7 days/week for 26 weeks

• Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline and every 4 weeks for duration of the study

• Circadian Stimulus (CS) values using the Daysimeter

  During waking hours for 26 weeks

Study Arms (2)

Light Intervention Therapy (LIT) then Sham LIT

ACTIVE COMPARATOR

The LIT will begin at the patient's home and will be presented for 10 weeks. A washout period of 1 month will be scheduled to diminish carryover effects of the first therapy arm, then patients will begin the Sham LIT.

Device: Lighting Intervention Therapy; Device: Sham LIT

Sham LIT then Light Intervention Therapy

ACTIVE COMPARATOR

LIT will be performed identical to Arm 1, except for switchover of active LIT and Sham. A washout period of 1 month will be scheduled to diminish carryover effects of the LIT arm.

Device: Lighting Intervention Therapy; Device: Sham LIT

Interventions

Lighting Intervention Therapy DEVICE

The LIT will provide high circadian stimulation during the day produced by light sources that provide moderate light levels of spectra that are tuned to the sensitivity of the circadian system. The TLI intervention will remain in place and will be delivered to participants for 10 weeks each in a counterbalanced manner. Combining spectrum and light level, LIT will allow the research team to: (a) use a light source that will stimulate the circadian system, and (b) provide the participants with options as to how the light treatment will be delivered. The research team will deliver at least 300-400 lux at the eye of the bluish-white light during the day (CS of 0.4 or greater) and about 50 lux at the eye during the evening hours (CS of less than 0.1) and when the control lighting intervention is used.

Light Intervention Therapy (LIT) then Sham LIT; Sham LIT then Light Intervention Therapy

Sham LIT DEVICE

A placebo comparison lighting intervention will be used. The comparison lighting intervention will remain in place and will be delivered to participants for 10 weeks.

Light Intervention Therapy (LIT) then Sham LIT; Sham LIT then Light Intervention Therapy

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Study Officials

• Priti Balchandani, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

• Mariana Figueiro, PhD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 25, 2022
• First Posted: October 27, 2022
• Study Start: February 28, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: June 29, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)