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

Enrolling by invitation · Phase 2 · Has a placebo group

Conditions studied: Frail Elderly Syndrome

In brief

This is a pilot study to test the efficacy of the anti-inflammatory drug (Fisetin) in reducing inflammatory factors in blood in elderly adults and to test the efficacy of the drug (Fisetin) in reducing frailty and markers of inflammation, insulin resistance, and bone resorption in elderly adults.

Key facts

Study ID

NCT03675724

Run by

Mayo Clinic

People needed

40

Starts

2018-11-15

Expected to finish

2027-11-01

Last updated by the study team

2026-05-22

Who can join

Age: 70 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥ 70 years

You may not qualify if…

• Unable or unwilling to give informed consent
• Pregnant
• Body weight >150 kg or body mass index (BMI) > 50
• QTc>450 msec
• Total bilirubin >2X upper limit of normal
• Inability to tolerate oral medication
• Abnormality in any of the screening laboratory studies (see below)
• 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. See Appendices 1-3.
• 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.

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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