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Short Term Sirolimus Treatment and MRI of the Brain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05386914
Recruitment Status : Not yet recruiting
First Posted : May 23, 2022
Last Update Posted : May 23, 2022
Sponsor:
Information provided by (Responsible Party):
Ai-Ling Lin, PhD, University of Missouri-Columbia

Brief Summary:
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. 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.

Condition or disease Intervention/treatment Phase
Genetic Predisposition to Disease Healthy Volunteers Drug: Sirolimus Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 105 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Masking Description: The member of the study team carrying out the MRI imaging and image analysis will be blinded to the APOE genotype of the subject, subject's family history, and treatment category.
Primary Purpose: Basic Science
Official Title: Short Term Apolipoprotein E (ApoE)-Dependent Cerebral Blood Flow Response to Sirolimus in Cognitively Normal Adults
Estimated Study Start Date : July 2022
Estimated Primary Completion Date : July 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Sirolimus

Arm Intervention/treatment
Experimental: Carrier APOE4 Drug: Sirolimus
1 mg of Sirolimus taken orally once a day for 4 weeks.

Non-Carrier APOE4 Drug: Sirolimus
1 mg of Sirolimus taken orally once a day for 4 weeks.




Primary Outcome Measures :
  1. Change in Cerebral blood flow as measured on MRI after 4 weeks of Sirolimus [ Time Frame: Assessed at Visit 2 immediately before starting sirolimus and Visit 4 after 4 weeks of continuous sirolimus ]
    Rate of blood perfusion expressed as mL/g/min in hippocampus



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 1. Age 45-65 y/o
  • 2. Male or female, all ethnic groups
  • 3. Montreal Cognitive Assessment (MoCA) score greater than or equal to 26
  • 4. Clinical Dementia Rating (CDR) Staging Instrument = 0
  • 5. Carrier Cohort: APOE4 homozygous or heterozygous
  • 6. Non-Carrier cohort: no APOE4 gene identified

Exclusion Criteria:

  • 1. Diagnosis of mild cognitive impairment (MCI) or dementia, including Alzheimer's disease
  • 2. BMI ≥35 (based on MRI feasibility)
  • 3. Diabetes (HBA1c≥6.5% or antidiabetic medications)
  • 4. History of skin ulcers or poor wound healing
  • 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. Use of anti-platelet or anti-coagulant medications other than aspirin
  • 7. Current medications that affect cytochrome P450 3A4 (CYP3A4)
  • 8. Immunosuppressant therapy within the last year
  • 9. Chemotherapy or radiation treatment within the last year
  • 10. Current or chronic history of liver or kidney disease or known hepatic or biliary abnormalities
  • 11. Untreated hypertriglyceridemia (fasting triglycerides < 300 mg/dl)
  • 12. Current or chronic significant history of pulmonary disease
  • 13. Chronic heart failure
  • 14. Pregnancy or lactation
  • 15. Recent history (past six months) of myocardial infarction, active coronary artery disease, intestinal disorders, stroke, or transient ischemic attack
  • 16. Poorly controlled blood pressure (systolic BP>160 or diastolic BP>100 mmHg)
  • 17.Active inflammatory, Coronavirus (COVID-19), autoimmune, infectious, hepatic, gastrointestinal, malignant, and/or severe mental illness
  • 18. History of, or MRI, or CT positive for, any space occupying brain lesion, including mass effect or abnormal intracranial pressure
  • 19. Organ transplant recipients
  • 20. History of Stroke
  • 21. History of ruptured intracranial aneurysm
  • 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. Likelihood of claustrophobia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05386914


Contacts
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Contact: Joanne Cassani 573-882-3677 cassanij@health.missouri.edu
Contact: Emily Cantrell 573-884-5372

Locations
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United States, Missouri
University of Missouri-Columbia
Columbia, Missouri, United States, 65212
Contact: Joanne Cassani    573-882-3677    cassanij@health.missouri.edu   
Contact: Emily Cantrell    573-884-5372    fergasone@health.missouri.edu   
Principal Investigator: Ai-Ling Lin, PhD         
Sub-Investigator: David Beversdorf, MD         
Sub-Investigator: Altes Talissa, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
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Principal Investigator: Ai-Ling Lin, PhD University of Missouri-Columbia
Publications:

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Responsible Party: Ai-Ling Lin, PhD, Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT05386914    
Other Study ID Numbers: 2091042
First Posted: May 23, 2022    Key Record Dates
Last Update Posted: May 23, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Disease Susceptibility
Genetic Predisposition to Disease
Disease Attributes
Pathologic Processes
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs