Fisetin to Reduce Senescence and Mobility Impairment in PAD

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06399809
Phase
PHASE2
Status
Recruiting
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Conditions

  • Aging
  • Claudication
  • Peripheral Arterial Disease
  • Peripheral Vascular Diseases
  • Walking, Difficulty

Eligibility Criteria

Sex
ALL
Age
50 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Fisetin — DRUG
    Fisetin is a flavanol, present in strawberries, apples, and persimmons, that destroys senescent cells (i.e. a senolytic therapy). Of three senolytic therapies being tested in clinical trials, fisetin has the best safety profile.
  • Placebo — DRUG
    The placebo will be matched to the Fisetin intervention

Study Details

The investigators propose a pilot randomized trial to gather preliminary data to test the hypothesis that Fisetin will reduce abundance of senescent cells in blood, skeletal muscle, and both subcutaneous and inter muscular adipose tissue and improve 6-minute walk distance in 34 people with peripheral artery disease (PAD). the investigators will determine whether greater declines in abundance of cells with senescent markers are associated with greater improvement in 6-minute walk distance in people with peripheral artery disease. In exploratory analyses, the investigators will assess whether Fisetin reduces interleukin-6 (IL-6) and novel senescent markers in adipose tissue, muscle, and/or blood.

Key Dates

Start date
Sep 30, 2024
Status verified
Apr 2026
Primary completion
Nov 30, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
34 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Fisetin
    Sharp Clinical Services will provide fisetin (100 mg capsules). Randomized participants will receive fisetin 20 mgs/kg once daily for two days, followed by 12 days without therapy. Fisetin will be dosed in 100 mg tablets. Dosing will be rounded to the nearest 100 mg. For example, a 73 kg participant with a dose of 1,460 mg (i.e.73 kg x 20 mg) receives 1,500 mgs daily (i.e. 15 x 100 mg capsules) for two days every 14 days.
  • Placebo Comparator: Placebo
    Sharp Clinical Services will provide placebo (100 mg capsules). Randomized participants will receive placebo 20 mgs/kg once daily for two days, followed by 12 days without therapy. Placebo will be dosed in 100 mg tablets. Dosing will be rounded to the nearest 100 mg. For example, a 73 kg participant with a dose of 1,460 mg (i.e.73 kg x 20 mg) receives 1,500 mgs daily (i.e. 15 x 100 mg capsules) for two days every 14 days.

Primary Outcome Measure

Six-minute Walk Distance [ Time Frame: Measured at baseline and 4 month follow-up ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611-3008
Kathryn J Domanchuk
[email protected]
312-503-6438
Mary M. McDermott (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University Feinberg School of Medicine· Chicago, IL

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