RECRUITING

Short Term Sirolimus Treatment and MRI of the Brain and Lungs

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Conditions

Genetic Predisposition to DiseaseHealthy Volunteers

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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

Alzheimer's disease is a devastating neurodegenerative disease characterized by accumulation of clumps (also called plaques) and bundles of fibers (also called tangles) in the brain, for which there is currently no cure. Sirolimus is an FDA-approved medication which may improve the blood flow to the brain. Part I: This study is designed to see if sirolimus treatment improves MRI blood flow to the brain in individuals with and without a genetic predisposition to Alzheimer's disease. Part I of this study is complete and no longer enrolling participants. Part II: Ongoing research will expand the genetic predisposition cohort and further explore the drug's impact on the lung perfusion via hyperpolarized xenon-129 gas MRI and the brain-vascular connection. Only subjects who are APOE4 carriers will be enrolled in Part II. Hyperpolarized xenon-129 gas MRI is a non-invasive technique in which a subject inhales a bolus of hyperpolarized xenon-129 gas which can be directly imaged by the MRI as it physiologically distributes itself throughout the lung interior and within tissue and red blood cells. It thus allows for direct imaging and quantification of regional lung function: ventilation, gas-exchange, and perfusion. The relationship between pulmonary vascular function and brain perfusion is largely unstudied. We hope to investigate the relationship between pulmonary vascular function and cerebral blood flow by quantifying both lung and brain perfusion before and after the administration of Sirolimus.

Official Title

Short Term Apolipoprotein E (ApoE)-dependent Cerebral Blood Flow and Lung Perfusion Response to Sirolimus in Cognitively Normal Adults

Quick Facts

Study Start:2023-03-02
Study Completion:2027-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05386914

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:45 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 1. Age 45-65 y/o
  2. * 2. Male or female, all ethnic groups
  3. * 3. Montreal Cognitive Assessment (MoCA) score greater than or equal to 26
  4. * 4. Clinical Dementia Rating (CDR) Staging Instrument = 0
  5. * 5. Carrier Cohort: APOE4 homozygous or heterozygous
  6. * 6. Non-Carrier cohort: no APOE4 gene identified
  1. * 1. Diagnosis of mild cognitive impairment (MCI) or dementia, including Alzheimer's disease
  2. * 2. BMI ≥35 (based on MRI feasibility)
  3. * 3. Diabetes (HBA1c≥6.5% or antidiabetic medications)
  4. * 4. History of skin ulcers or poor wound healing
  5. * 5. Current tobacco or illicit drug use or alcohol abuse (defined as ≥4 per day or ≥14 per week for men and ≥3 per day or ≥7 per week for women) (Per NIAAA guidelines)
  6. * 6. Use of anti-platelet or anti-coagulant medications other than aspirin
  7. * 7. Current medications that affect cytochrome P450 3A4 (CYP3A4)
  8. * 8. Immunosuppressant therapy within the last year
  9. * 9. Chemotherapy or radiation treatment within the last year
  10. * 10. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities
  11. * 11. Untreated hypertriglyceridemia (fasting triglycerides \< 300 mg/dl)
  12. * 12. Current or chronic significant history of pulmonary disease
  13. * 13. Chronic heart failure
  14. * 14. Pregnancy or lactation
  15. * 15. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
  16. * 16. Poorly controlled blood pressure (systolic BP\>160 or diastolic BP\>100 mmHg)
  17. * 17.Active inflammatory, Coronavirus (COVID-19), autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness
  18. * 18. History of, or MRI, or CT positive for, any space occupying brain lesion, including mass effect or abnormal intracranial pressure
  19. * 19. Organ transplant recipients
  20. * 20. History of Stroke
  21. * 21. History of ruptured intracranial aneurysm
  22. * 22. Any condition for which a MRI procedure is contraindicated. Some examples include: metallic material in the body, such as pacemakers, metallic clips, etc.
  23. * 23. Likelihood of claustrophobia

Contacts and Locations

Study Contact

Jessica Call
CONTACT
573-882-0515
jccfx@health.missouri.edu
Jenn Cornelius-Green
CONTACT
573-884-5483
corneliusj@health.missouri.edu

Principal Investigator

Ai-Ling Lin, PhD
PRINCIPAL_INVESTIGATOR
University of Missouri-Columbia

Study Locations (Sites)

University of Missouri-Columbia
Columbia, Missouri, 65212
United States

Collaborators and Investigators

Sponsor: University of Missouri-Columbia

  • Ai-Ling Lin, PhD, PRINCIPAL_INVESTIGATOR, University of Missouri-Columbia

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 Date2023-03-02
Study Completion Date2027-12

Study Record Updates

Study Start Date2023-03-02
Study Completion Date2027-12

Terms related to this study

Additional Relevant MeSH Terms

  • Genetic Predisposition to Disease
  • Healthy Volunteers