COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-02-28
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05596994

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:50 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * the patients must have undergone PET scans to measure amyloid protein accumulation within the past year
  2. * Those taking antidepressants will be included, but type of medicine and dosage intake will be monitored.
  3. * 50 years and older
  4. * 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.
  5. * 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)
  1. * Those taking sleep medication will be not included
  2. * 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)
  3. * residence in a skilled nursing facility or long-term care
  4. * indication for psychiatric hospitalization or acute suicidality in the opinion of the physician
  5. * recent changes in psychotropics (14 days)
  6. * major organ failure (e.g., kidney failure)
  7. * uncontrolled generalized disorders such as hypertension or diabetes
  8. * obstructing cataracts, macular degeneration, and blindness
  9. * severe sleep apnea:
  10. * restless leg syndrome (RLS):
  11. * history of:
  12. * severe photosensitivity dermatitis
  13. * severe progressive retinal disease (e.g., macular degeneration), or;
  14. * a permanently dilated pupil (e.g., after certain types of cataract surgery)
  15. * 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

Contacts and Locations

Principal Investigator

Priti Balchandani, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Mariana Figueiro, PhD
PRINCIPAL_INVESTIGATOR
Icahn School of Medicine at Mount Sinai

Study Locations (Sites)

Icahn School of Medicine at Mount Sinai
New York, New York, 10029
United States

Collaborators and Investigators

Sponsor: Icahn School of Medicine at Mount Sinai

  • Priti Balchandani, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai
  • Mariana Figueiro, PhD, PRINCIPAL_INVESTIGATOR, Icahn School of Medicine at Mount Sinai

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-28
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2023-02-28
Study Completion Date2025-05-30

Terms related to this study

Additional Relevant MeSH Terms

  • Mild Cognitive Impairment
  • Alzheimer's Disease