Senolytics for Secondary Progressive MS

December 4, 2025 updated by: Yinan Zhang, Ohio State University

Senolytics to Improve Physical and Cognitive Function in Older Adults With Multiple Sclerosis

This is a clinical trial to see whether senolytic therapy is safe and feasible for patients with secondary progressive MS and whether treatment improves physical and thinking abilities. The study seeks to enroll adults with secondary progressive MS (SPMS), aged 50-85, who are not currently taking a MS disease-modifying therapy and have noticed their MS symptoms getting worse. People who join the study will take the medicines dasatinib and quercetin by mouth every two weeks for three months. These medicines work together to remove old, damaged cells that may cause inflammation and slow the repair of nerves. Participants will also be followed for one year from enrollment to monitor for treatment effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Multiple sclerosis (MS) is a chronic immune-mediated inflammatory and neurodegenerative disorder of the central nervous system (CNS), which afflicts approximately one million people in the United States. Age is the strongest driver of disease course in MS. With increasing age, most older adults with MS develop a progressive disease phenotype characterized by gradual accrual of irreversible neurological disability, for which there are no effective treatments that reliably slow disease progression. Cellular senescence is a hallmark of aging, whereby senescent cells accumulate with age and produce mediators of inflammation through the senescence-associated secretory phenotype (SASP). In MS, senescent cells have been identified in both the central nervous system and peripheral immune compartments contributing to SASP expression, promoting chronic inflammation, axonal damage, and failure of myelin repair, and ultimately leading to functional decline. Senescent cells can be selectively removed by senolytic drugs, which delay age-related dysfunction in animal models and show potential for improving functional outcomes in human clinical trials. The senolytic drug combination of dasatinib and quercetin (D+Q) selectively induces apoptosis of senescent cells in human tissue. Our pilot data shows D+Q treatment improves function and survival in experimental autoimmune encephalomyelitis, the widely used animal model of MS. Emerging evidence from early phase clinical trials of D+Q in age-related diseases shows improvement of gait speed in idiopathic pulmonary fibrosis and CNS penetrance of dasatinib in Alzheimer's disease. However, studies of senolytic therapy for people with MS have yet to be conducted. The investigators hypothesize that treatment with D+Q will be well tolerated, improve physical and cognitive function, reduce circulating biomarkers of senescence and neurodegeneration, and attenuate T-cell immune exhaustion. The investigators will test this hypothesis through a single arm, open label, study to 1) determine the feasibility of 3 months of intermittent D+Q treatment in 30 older adults age 50-85 with secondary progressive MS and 2) to obtain preliminary data of D+Q treatment on physical and cognitive function and 3) serum biomarkers of senescence, neurodegeneration, and the circulatory T cell repertoire. Targeting cellular senescence represents a novel strategy for treating progressive MS, and results from the study will lay the foundation for a future randomized controlled trial of senolytics to treat progressive MS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43210
        • Ohio State Martha Morehouse Outpatient Care
        • Contact:
        • Contact:
          • Phone Number: 6142934969

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Individuals aged 50-85 with SPMS diagnosed using the 2024 McDonald Criteria
  2. Not treated with a DMT for MS within the last 6 months or have used alemtuzumab, cladribine, or mitoxantrone.
  3. Evidence of MS progression over the past 12 months.

Exclusion Criteria:

  1. Unstable coronary artery disease (myocardial infarction within 6 months or angina)
  2. Hospitalization within 6 months
  3. Stroke or transient ischemic attack in the past 6 months
  4. Pulmonary arterial hypertension
  5. Current or chronic history of liver disease
  6. Alzheimer's or Parkinson's disease
  7. Drug or alcohol abuse in the previous 5 years
  8. History of coagulation disorders, central nervous system hemorrhage, or gastrointestinal hemorrhage
  9. History of angina or myocardial infarction, arrhythmia, or heart failure at any time
  10. QTc prolongation
  11. Anemia (Hgb<9), thrombocytopenia (platelets<50,000 per microliter), or neutropenia (ANC< 1000 per microliter)
  12. Moderate hypokalemia (2.9 mmol/L) and moderate hypomagnesemia (0.9-1.1 mg/dL or 0.37-0.45 mmol/L)
  13. ALT/AST >1.5x ULN, total bilirubin >ULN, and alkaline phosphatase >2x ULN
  14. Chronic renal disease (glomerular filtration rate < 30 mL/min/1.73 m2)
  15. Alcohol intake greater than 2 drinks/day for men and greater than 1 drink/day for women
  16. Anti-arrhythmic medications known to cause QTc prolongation
  17. Antipsychotics and anxiolytics
  18. Anti-platelet or anti-coagulant medications other than aspirin
  19. Quinolone antibiotics
  20. Pregnant or lactating subjects or subjects intending to become pregnant or to donate egg/sperm
  21. Participants with p16INK4a below the median of SPMS patients in the OSU Aging and MS Cohort
  22. Use of drugs metabolized by the same liver enzymes as D or Q

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Treatment
Dasatinib and quercetin
Drug: Dasatinib and quercetin
Participants will receive 100 mg of dasatinib and 1250 mg of quercetin orally once a day for 2 days every 2 weeks over 12 consecutive weeks
Other Names:
  • D+Q

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participant retention rate
Time Frame: Baseline until 3 months
Participant retention rate with D+Q therapy with no more than one missed study visit
Baseline until 3 months
Recruitment feasibility
Time Frame: Baseline
The number of subjects screened to identify eligible participants
Baseline
Frequency of adverse drug effects of dasatinib and quercetin
Time Frame: From baseline through study completion at 1 year
Frequency of adverse drug effects of dasatinib and quercetin
From baseline through study completion at 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ohio State University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 15, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 15, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 19, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 8, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • STUDY20251750

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

The data management and sharing plan will be consistent with the NIH Data Sharing Policy and Implementation Guidance which recognizes the need to make the research data generated from the NIH support projects available to the scientific community while ensuring that the privacy and autonomy of research participants are respected, and that confidential/proprietary data are appropriately protected. Data will include demographic, clinical, functional, and cognitive data from study participants, in addition to banked blood, urine, and lymphocytes. All investigators wishing to access the data will submit a brief proposal to Drs. Zhang or Kirkland describing their research project, data needs, regulatory approvals, and mechanisms to assure patient confidentiality. Upon affirmative review by the Dr. Zhang and co-investigators of this study, a data-sharing agreement will be signed and the requesting investigators will be given a working electronic data file and appropriate documentation.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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