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Anti-aging Agent

Fisetin for PAD (FIRST Trial)

Phase 2

Recruiting

Research Sponsored by Northwestern University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Vascular lab evidence of PAD (such as a toe brachial pressure < 0.70 or an ankle brachial index less than or equal to 0.90), or angiographic evidence of PAD defined as at least 70% stenosis of an artery supplying the lower extremities.

An ABI of >0.90 and <=1.00 who experience a 20% or greater drop in ABI in either leg after the heel-rise test will also be included.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up measured at baseline and 4 months

Summary

This trial aims to test if Fisetin can reduce senescent cells in different parts of the body and improve walking distance in people with peripheral artery disease. They will also see if the reduction in

Who is the study for?

This trial is for people with peripheral artery disease (PAD), which can cause limited mobility and difficulty walking. Participants must have specific vascular lab evidence of PAD or a drop in ABI after the heel-rise test. It's not suitable for those who don't meet these criteria.

What is being tested?

The study tests if Fisetin, a compound thought to reduce cell aging, can decrease senescent cells and improve walking distance over six minutes compared to a placebo. The effects on inflammation markers and other aging indicators will also be explored.

What are the potential side effects?

Potential side effects are not detailed here but could include reactions similar to other supplements or medications aimed at reducing cellular aging or inflammation.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with PAD based on vascular tests or angiography.

Select...

My ABI is between 0.90 and 1.00, and it drops by 20% or more after a physical test.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ measured at baseline and 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~measured at baseline and 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and measured at baseline and 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Six-minute Walk Distance

Secondary study objectives

Gastrocnemius perfusion

Hand Grip Strength

Number of cells with senescence markers

+1 more

Other study objectives

Abundance of cells with central nuclei

Abundance of cells with increased myofiber size

Abundance of interleukin-6 markers

+4 more

Side effects data

From 2023 Phase 1 & 2 trial • 75 Patients • NCT04210986

38%

Arthralgia

15%

Pain in Extremity

12%

Lab Findings

12%

Nausea

Fatigue

Back Pain

Headache

Muscle Cramp

Flatulence

Dry Mouth

Rash Maculo-Papular

Covid 19

Bladder Perforation

Neoplasms

Rotator Cuff Injury

100%

80%

60%

40%

20%

Study treatment Arm

Placebo

Fisetin

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: FisetinExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fisetin

2016

Completed Phase 2

~250

0 / 2Eligibility criteria met