ALSENLITE: Senolytics for Alzheimer's Disease

January 20, 2026 updated by: Vijay K. Ramanan, Mayo Clinic

ALSENLITE: An Open-Label Pilot Study of Senolytics for Alzheimer's Disease

This study is being done to evaluate the safety and feasibility of using Dasatinib and Quercetin together in subjects with Mild Cognitive Impairment (MCI) or Alzheimer's disease.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The underlying processes driving chronic neurodegeneration in Alzheimer's disease (AD) and related neurodegenerative disorders are largely unknown. Aging is the major risk factor for AD. Moreover, individuals with AD suffer from significantly more co-morbid conditions than demographically matched older adults. This study is an open-label pilot study of intermittent administration of the senolytic drug regimen Dasatinib (D) + Quercetin (Q) in symptomatic adults over 55 with clinical diagnosis of probable Alzheimer's Disease and Alzheimer's biomarker positivity by tau-PET.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2
  • 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
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Men and women of age 55 years and older at the time of enrollment
  2. Clinical diagnosis of symptomatic probable AD (MMSE 26 to 15 or Short Test of Mental Status 31 to 15 inclusive and/or Clinical Dementia Rating Scale/CDR = 0.5 to 2, inclusive)
  3. Not on cholinesterase inhibitors or memantine; or if on cholinesterase inhibitors and/or memantine, on a stable dose for at least three months
  4. Body Mass Index (BMI) within range of 19 - 50 kg/ m2
  5. Participants must be accompanied by a LAR designated to sign informed consent and to provide study partner reported outcomes at all visits
  6. Participants must have no plans to travel over the ~3 months between Visits 3 and 14 that interfere with study visits
  7. Tau positivity by brain PET imaging
  8. Adequate blood counts i.e. platelets > 50,000 per microliter; HB > 9/dL, and ANC > 1000 per microliter
  9. Availability and consent from a LAR.

Exclusion Criteria:

  1. Unwilling or unable to give informed consent
  2. Pregnancy
  3. QTc > 450 msec on baseline ECG
  4. MRI contraindications
  5. Presence of uncontrolled psychiatric disorder (as per clinical judgment)
  6. Presence of uncontrolled systemic lupus erythematosus (as per clinical judgment)
  7. Substance or alcohol abuse (current alcohol use > 3 alcoholic beverage/day or > 21 per week and as per clinical judgment)
  8. Hearing, vision, or motor deficits despite corrective devices (as per clinical judgment)
  9. Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6 months
  10. Chronic heart failure (as per clinical judgment)
  11. Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments (as per clinical judgment)
  12. Positive SARS-CoV-2 test within 30 days prior to enrollment
  13. AST/ALT > 2.5x upper limit normal
  14. Presence of significant liver disease with total bilirubin > 2X upper limit or as per clinical judgment
  15. Inability to tolerate oral medication (as per clinical judgment)
  16. Abnormality in any of the screening laboratory studies (see section 6.21.2) or as per clinical judgment
  17. Malabsorption (as per clinical judgment)
  18. Known human immunodeficiency virus infection (as per clinical judgment)
  19. Known active hepatitis B or C infection
  20. Invasive fungal or viral infection (as per clinical judgment)
  21. Known hypersensitivity or allergy to D or Q
  22. Uncontrolled pleural/pericardial effusions or ascites (as per clinical judgment)
  23. New/active invasive cancer except non-melanoma skin cancers
  24. Inability to tolerate oral medications (as per clinical judgment)
  25. Currently taking AND unable to safely hold any of the medications listed in Appendix 1 during the days IP is administered and for 36 hours after IP administration.
  26. Uncontrolled diabetes (defined as HbA1c > 7% or as per clinical judgment).
  27. Gastric bypass/reduction
  28. Crohn's disease
  29. Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinase or ESR) (as per clinical judgment)
  30. eGFR < 10 ml/ min/ 1.73 m2
  31. Creatinine clearance < 60 mL/min/1.73 m2
  32. Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)
  33. On antiplatelet agents (e.g., full dose Aspirin, Clopidogrel etc.). Baby aspirin (81 mg), if absolutely necessary from cardiac perspective, will be allowed
  34. Presence of any condition that the Investigator believes would put the subject at risk or would preclude the patient from successfully completing all aspects of the trial

Involvement of special vulnerable populations: We will not involve special vulnerable populations, such as fetuses, neonates, pregnant women, children, prisoners, institutionalized individuals, or others who may be considered vulnerable populations except for patients with dementia. Therefore, availability and consent from a LAR is an inclusion criterion.

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
Intervention / Treatment
Experimental: Dasatinib plus Quercetin Treatment Goup
Subjects with MCI or Alzheimer's disease will take Dasatinib and Quercetin by mouth at the same times for 2 days out of every 15 days for 6 cycles lasting for a total of 77 days (12 concurrent doses of each agent).
Drug: Dasatinib
100 mg capsule daily for 2 consecutive days administered orally every 15 days (2 days on drug, 13 days off) for 6 cycles
Drug: Quercetin
Four 250 capsules once daily (total daily dosage 1000 mg) administered orally for 2 consecutive days every 15 days (2 days on drug, 13 days off) for 6 cycles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety and Tolerability
Time Frame: 11 weeks
Safety evaluations will be conducted including assessment for adverse events, compliance to the study drug regimen, physical examinations or assessments, vital signs, and laboratory assessments.
11 weeks

Collaborators and Investigators

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

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Vijay K. Ramanan, MD, PhD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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 (Actual)

July 6, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 4, 2021

First Submitted That Met QC Criteria

March 4, 2021

First Posted (Actual)

March 5, 2021

Study Record Updates

Last Update Posted (Actual)

January 22, 2026

Last Update Submitted That Met QC Criteria

January 20, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-003394

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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