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Mild Cognitive ImpairmentPhase 1/2NCT04785300

ALSENLITE: Senolytics for Alzheimer's Disease

A Phase 1/2 study testing Dasatinib and Quercetin in people with Mild Cognitive Impairment and Alzheimer Disease, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Mild Cognitive Impairment, Alzheimer Disease
What is being tested?
Dasatinib and Quercetin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
6 Jul 2022to Dec 2026
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

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 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Men and women of age 55 years and older at the time of enrollment
  • 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)
  • Not on cholinesterase inhibitors or memantine; or if on cholinesterase inhibitors and/or memantine, on a stable dose for at least three months
  • Body Mass Index (BMI) within range of 19 - 50 kg/ m2
  • Participants must be accompanied by a LAR designated to sign informed consent and to provide study partner reported outcomes at all visits
  • Participants must have no plans to travel over the ~3 months between Visits 3 and 14 that interfere with study visits
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  • Tau positivity by brain PET imaging
  • Adequate blood counts i.e. platelets > 50,000 per microliter; HB > 9/dL, and ANC > 1000 per microliter
  • Availability and consent from a LAR.

Who cannot join

  • Unwilling or unable to give informed consent
  • Pregnancy
  • QTc > 450 msec on baseline ECG
  • MRI contraindications
  • Presence of uncontrolled psychiatric disorder (as per clinical judgment)
  • Presence of uncontrolled systemic lupus erythematosus (as per clinical judgment)
Show all 35Show fewer
  • Substance or alcohol abuse (current alcohol use > 3 alcoholic beverage/day or > 21 per week and as per clinical judgment)
  • Hearing, vision, or motor deficits despite corrective devices (as per clinical judgment)
  • Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6 months
  • Chronic heart failure (as per clinical judgment)
  • Neurologic, musculoskeletal, or other condition that limits subject's ability to complete study physical assessments (as per clinical judgment)
  • Positive SARS-CoV-2 test within 30 days prior to enrollment
  • AST/ALT > 2.5x upper limit normal
  • Presence of significant liver disease with total bilirubin > 2X upper limit or as per clinical judgment
  • Inability to tolerate oral medication (as per clinical judgment)
  • Abnormality in any of the screening laboratory studies (see section 6.21.2) or as per clinical judgment
  • Malabsorption (as per clinical judgment)
  • Known human immunodeficiency virus infection (as per clinical judgment)
  • Known active hepatitis B or C infection
  • Invasive fungal or viral infection (as per clinical judgment)
  • Known hypersensitivity or allergy to D or Q
  • Uncontrolled pleural/pericardial effusions or ascites (as per clinical judgment)
  • New/active invasive cancer except non-melanoma skin cancers
  • Inability to tolerate oral medications (as per clinical judgment)
  • 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.
  • Uncontrolled diabetes (defined as HbA1c > 7% or as per clinical judgment).
  • Gastric bypass/reduction
  • Crohn's disease
  • Myopathies (increased or low calcium, vitamin D deficiency, elevated creatine kinase or ESR) (as per clinical judgment)
  • eGFR < 10 ml/ min/ 1.73 m2
  • Creatinine clearance < 60 mL/min/1.73 m2
  • Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)
  • On antiplatelet agents (e.g., full dose Aspirin, Clopidogrel etc.). Baby aspirin (81 mg), if absolutely necessary from cardiac perspective, will be allowed
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Dasatinib, Quercetin
Medical subject headings
Cognitive Dysfunction, Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DasatinibDrug

    100 mg capsule daily for 2 consecutive days administered orally every 15 days (2 days on drug, 13 days off) for 6 cycles

  • QuercetinDrug

    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

Study groups in NCT04785300
Study groupRoleWhat they receive
Dasatinib plus Quercetin Treatment GoupExperimentalSubjects 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).
Receives: Drug: Dasatinib; Drug: Quercetin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and Tolerability

    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.

    Measured: 11 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2021
  2. Study start6 Jul 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04785300
Sponsor's protocol ID
19-003394
Status last verified
Jul 2026
First submitted
4 Mar 2021
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Andrews TD, Day GS, Irani SR, Kanekiyo T, Hickson LJ. Uremic Toxins, CKD, and Cognitive Dysfunction. J Am Soc Nephrol. 2025 Jun 1;36(6):1208-1226. doi: 10.1681/ASN.0000000675. Epub 2025 Feb 26.

    PubMed 40009460

  • Guerrero A, De Strooper B, Arancibia-Carcamo IL. Cellular senescence at the crossroads of inflammation and Alzheimer's disease. Trends Neurosci. 2021 Sep;44(9):714-727. doi: 10.1016/j.tins.2021.06.007. Epub 2021 Aug 5.

    PubMed 34366147

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Dasatinib and Quercetin in people with Mild Cognitive Impairment and Alzheimer Disease, run by Mayo Clinic 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 9 inclusion and 35 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: under way, not looking for participants, as of the sponsor's last update on 17 Jul 2026. 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 combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

This study is still under way. Results are not available in the source record yet.

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?

Safety and Tolerability (time frame: 11 weeks). 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 NCT04785300, which also lists 2 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 17 Jul 2026.

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