Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Women

Overview

About this study

The purpose of this study is test the effectiveness of the senolytic drug (Fisetin) in reducing senescent cell abundance in blood in elderly adults.

 

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria: 

  • Age ≥ 70 years old.

Exclusion Criteria:

  • Unable or unwilling to give informed consent.
  • Pregnant.
  • Body weight > 150 kg or body mass index (BMI) > 50.
  • Total bilirubin > 2X upper limit of normal.
  • Inability to tolerate oral medication.
  • Abnormality in any of the screening laboratory studies.
  • Human immunodeficiency virus infection.
  • Known active hepatitis B or C infection.
  • Invasive fungal or viral infection.
  • Known hypersensitivity or allergy to fisetin.
  • Uncontrolled pleural/pericardial effusions or ascites.
  • New/active invasive cancer except non-melanoma skin cancers.
  • Subjects taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g. cyclosporine, tacrolimus or sirolimus). If antifungals are absolutely necessary from an infectious disease perspective, then they will be allowed only if the levels are therapeutic.
  • Strong inhibitors of CYP3A4.
  • Tyrosine kinase inhibitor therapy.
  • Known hypersensitivity or allergy to fisetin.
  • Subjects on quinolone antibiotic therapy for treatment or for prevention of infections within 10 days.
  • Subjects taking H2-antagonists and unwilling to discontinue therapy for 1 week before and 2 weeks following enrollment.
  • Subjects taking potentially senolytic agents within the last year: Fisetin, Quercetin, Luteolin, Dasatinib, Piperlongumine, or Navitoclax.
  • Subjects currently taking drugs that induce cellular senescence: alkylating agents, anthracyclines, platins, other chemotherapy.
  • Subjects taking the following antimicrobial agents: Aminoglycosides, Azole antifungals (fluconazole, miconazole, voriconazole, itraconazole), Macrolides (clarithromycin, erythromycin), Antivirals (nelfinavir, indinavir, saquinavir, ritonavir, elbasvir/grazoprevir), Rifampin.
  • Subjects taking proton pump inhibitors who are unable or unwilling to reduce or hold therapy 2 days prior to and during the 2-day Fisetin dosing.
  • Subjects taking the following other drugs if they cannot be held for at least 2 days before and during administration of Fisetin: digoxin, lithium, all statins, repaglidine, bosentan, gemfibrozil, olmesartan, enalapril, valsartan, methotrexate, corticosteroids, , eluxadoline, eltrombopag, nitroglycerin, pioglitazone, glyburide, enzalutamide, ezetimibe, colchicine, imatinib, cyclosporine, tacolimus, sirolimus, carbamazepine, flecainide, phenytoin, phenobarbital, rifampicin, theophylline,celecoxib, desipramine, thioridazine, venlafaxine, tizanidine, atomoxetine, voriconazole, citalopram, diazepam, escitalopram, propranolol, clozapine, cyclobenzaprine, mexiletine, olanzapine, ondansetron, riluzole.
  • In order to ensure vitamin D sufficiency, we will also exclude subjects with serum 25-hydroxyvitamin D levels of < 20 ng/ml.
  • Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

James Kirkland, M.D., Ph.D.

Contact us for the latest status

Contact information:

Department of Medicine - Clinical Research Office

(507) 266-1944

RSTDOMCTU@mayo.edu

More information

Publications

Publications are currently not available
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CLS-20438802

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