Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults
AFFIRM-LITE
AFFIRM-LITE: A Phase 2 Randomized, Placebo-Controlled Study of Alleviation by Fisetin of Frailty, Inflammation, and Related Measures in Older Adults
1 other identifier
interventional
40
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2018
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 17, 2018
CompletedFirst Posted
Study publicly available on registry
September 18, 2018
CompletedStudy Start
First participant enrolled
November 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedNovember 20, 2025
November 1, 2025
7.4 years
September 17, 2018
November 17, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Decrease in blood inflammation markers
Percent decrease in blood inflammation markers
Seven Days
Study Arms (2)
Treatment
EXPERIMENTALFisetin 20mg/kg/day, orally for 2 consecutive days
Placebo
PLACEBO COMPARATORPlacebo capsules orally for 2 consecutive days
Interventions
Eligibility Criteria
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.
- +12 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic in Rochester
Rochester, Minnesota, 55905, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Robert Pignolo, MD, PhD
Mayo Clinic
- PRINCIPAL INVESTIGATOR
Sundeep Khosla, MD
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 17, 2018
First Posted
September 18, 2018
Study Start
November 15, 2018
Primary Completion
April 1, 2026
Study Completion (Estimated)
April 1, 2027
Last Updated
November 20, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share