NCT04946383

Brief Summary

Assessing the effects of Quercitin and Dasatinib over a 16 week period on participatns' epigenetic biological aging. The patients are being tested at baseline, halfway point, and after the trial period.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
25

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2020

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

December 16, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 3, 2021

Status Verified

August 1, 2021

Enrollment Period

1 year

First QC Date

June 11, 2021

Last Update Submit

August 2, 2021

Conditions

Aging

Keywords

QuercetinDasatinibEpigenomics

Outcome Measures

Primary Outcomes (1)

  • Epigenetic Age Test

    Change from baseline to 6 months

Secondary Outcomes (1)

  • Examining Methylation changes

    Change from baseline to 6 months

Study Arms (1)

Quercetin and Dasatinib supplements

EXPERIMENTAL

500mg Quercetin and 50mg Dasatinib oral capsules on Monday, Tuesday, Wednesday (3 days in a row) per month for the duration of 6 months.

Drug: Dasatinib plus Quercetin

Interventions

Dasatinib plus QuercetinDRUG

Dasatinib plus Quercetin

Quercetin and Dasatinib supplements

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Men and women
  • Ages 40 and older
  • Patient must be able to comply with treatment plan and laboratory tests

You may not qualify if:

  • Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
  • No immune system issues or immunodeficiency disease
  • No history of viral illness which could be reactivated by immune down regulation
  • Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke)
  • Diagnosis of a transient ischemic attack in the 6 months prior to screening
  • Patients infected with hepatitis, C or HIV
  • Patients with Body Mass Index (BMI) \> 40 kg/m2
  • Presence of active infection 9. Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study
  • Unable or unwilling to provide required blood sample for testing
  • As for the male-participants they are recommended to avoid fertilization for the first 6 months after the clinical trial.
  • If the patient has previously used Quercetin and Dasatinib.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Institute for Hormonal Balance

Orlando, Florida, 32819, United States

Location

Related Publications (3)

  • Cavalcante MB, Saccon TD, Nunes ADC, Kirkland JL, Tchkonia T, Schneider A, Masternak MM. Dasatinib plus quercetin prevents uterine age-related dysfunction and fibrosis in mice. Aging (Albany NY). 2020 Jan 18;12(3):2711-2722. doi: 10.18632/aging.102772. Epub 2020 Jan 18.

    PMID: 31955151BACKGROUND

  • Hickson LJ, Langhi Prata LGP, Bobart SA, Evans TK, Giorgadze N, Hashmi SK, Herrmann SM, Jensen MD, Jia Q, Jordan KL, Kellogg TA, Khosla S, Koerber DM, Lagnado AB, Lawson DK, LeBrasseur NK, Lerman LO, McDonald KM, McKenzie TJ, Passos JF, Pignolo RJ, Pirtskhalava T, Saadiq IM, Schaefer KK, Textor SC, Victorelli SG, Volkman TL, Xue A, Wentworth MA, Wissler Gerdes EO, Zhu Y, Tchkonia T, Kirkland JL. Senolytics decrease senescent cells in humans: Preliminary report from a clinical trial of Dasatinib plus Quercetin in individuals with diabetic kidney disease. EBioMedicine. 2019 Sep;47:446-456. doi: 10.1016/j.ebiom.2019.08.069. Epub 2019 Sep 18.

    PMID: 31542391BACKGROUND

  • Ermogenous C, Green C, Jackson T, Ferguson M, Lord JM. Treating age-related multimorbidity: the drug discovery challenge. Drug Discov Today. 2020 Aug;25(8):1403-1415. doi: 10.1016/j.drudis.2020.06.016. Epub 2020 Jun 20.

    PMID: 32574698BACKGROUND

MeSH Terms

Interventions

DasatinibQuercetin

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesFlavonolsFlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Edwin Lee, MD

    The Institute for Hormonal Balance

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: prospective non-randomized clinical study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2021

First Posted

June 30, 2021

Study Start

December 16, 2020

Primary Completion

December 31, 2021

Study Completion

June 30, 2022

Last Updated

August 3, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)