AgingPhase 2NCT04946383
Safety and Effectivness of Quercetin & Dasatinib on Epigenetic Aging
A Phase 2 study testing Dasatinib plus Quercetin in people with Aging, run by TruDiagnostic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Dasatinib plus Quercetin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Dec 2020to 30 Jun 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women
- Ages 40 and older
- Patient must be able to comply with treatment plan and laboratory tests
Who cannot join
- 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
Show all 11Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Institute for Hormonal Balance
Orlando, Florida, 32819
About this study
Official title: The Safety and Effectivness of Quercetin and Dasatinib on the Epigenetic Aging Rates in Healthy Individuals
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.
Read the detailed description
This is a prospective non-randomized clinical study of 20-25 patients to evaluate the effectiveness of Quercetin and Dasatinib supplements on the patient's epigenetic aging rate. The investigators predict that Quercetin and Dasatinib combined will slow cell proliferation and thus decelerate the rate of aging.
There is evidence that Quercetin and Dasatinib slows cell proliferation and decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of Quercetin and Dasatinib as an effective treatment option to improve clinical care of healthy individual's epigenetic aging rate thus prolonging longevity.
Despite considerable effort, successful treatment of reversing one's biological age has been shown to be a difficult therapeutic challenge. There is evidence that Dasatinib+Quercetin(Quercetin and Dasatinib) is a safe and effective treatment option to improve clinical care of healthy individual's biological age. Studies have shown that Dasatinib+Quercetin slows cell proliferation and decelerates aging and the risk of age-related diseases.
- Conditions
- Aging
- Being tested
- Dasatinib plus Quercetin
- Keywords
- Quercetin, Dasatinib, Epigenomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dasatinib plus QuercetinDrug
Dasatinib plus Quercetin
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Dasatinib plus Quercetin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetic Age Test
Measured: Change from baseline to 6 months
Secondary outcomes (1)
Examining Methylation changes
Methylation analysis via the Illumina 850k epic array. Methylation will be assessed at 850,000 spots on the DNA, these are located on CpG sites. These are the spots on DNA that have cytosine and guanine right next to each other.
Measured: Change from baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start16 Dec 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective non-randomized clinical study
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TruDiagnostic
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edwin Lee, MD, Principal investigator, The Institute for Hormonal Balance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946383
- Sponsor's protocol ID
- IHB-QD-001
- Status last verified
- Aug 2021
- First submitted
- 11 Jun 2021
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31955151Hickson 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.
PubMed 31542391Ermogenous 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.
PubMed 32574698
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Effectivness of Quercetin and Dasatinib on the Epigenetic Aging Rates in Healthy Individuals
- ClinicalTrials.gov ID
- NCT04946383
- Acronym / sponsor ID
- IHB-QD-001
- Conditions
- Aging
- Keywords
- Quercetin, Dasatinib, Epigenomics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- TruDiagnosticIndustry (pharma, biotech, devices)
- Study start
- 16 Dec 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective non-randomized clinical study of 20-25 patients to evaluate the effectiveness of Quercetin and Dasatinib supplements on the patient's epigenetic aging rate. The investigators predict that Quercetin and Dasatinib combined will slow cell proliferation and thus decelerate the rate of aging.
There is evidence that Quercetin and Dasatinib slows cell proliferation and decelerates aging and the risk of age-related diseases. The aim of this pilot study is to evaluate the safety, efficacy and feasibility of Quercetin and Dasatinib as an effective treatment option to improve clinical care of healthy individual's epigenetic aging rate thus prolonging longevity.
Despite considerable effort, successful treatment of reversing one's biological age has been shown to be a difficult therapeutic challenge. There is evidence that Dasatinib+Quercetin(Quercetin and Dasatinib) is a safe and effective treatment option to improve clinical care of healthy individual's biological age. Studies have shown that Dasatinib+Quercetin slows cell proliferation and decelerates aging and the risk of age-related diseases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective non-randomized clinical study
| Arm | Type | Receives |
|---|---|---|
| Quercetin and Dasatinib supplements | Experimental | Drug: Dasatinib plus Quercetin500mg Quercetin and 50mg Dasatinib oral capsules on Monday, Tuesday, Wednesday (3 days in a row) per month for the duration of 6 months. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Men and women
- Ages 40 and older
- Patient must be able to comply with treatment plan and laboratory tests
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dasatinib plus QuercetinDasatinib plus Quercetin | Drug | Quercetin and Dasatinib supplements |
Primary outcome
Epigenetic Age Test
Time frame: Change from baseline to 6 months
1 secondary outcome
Examining Methylation changes
Time frame: Change from baseline to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
- Background: PubMed 31955151Cavalcante 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.
- Background: PubMed 31542391Hickson 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.
- Background: PubMed 32574698Ermogenous 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edwin Lee, MD principal investigator
The Institute for Hormonal Balance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dasatinib plus Quercetin in people with Aging, run by TruDiagnostic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetic Age Test (time frame: Change from baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04946383, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.