ALSENLITE: Senolytics for Alzheimer's Disease

Running, not enrolling · Phase 1/Phase 2

Conditions studied: Mild Cognitive Impairment, Alzheimer Disease

In brief

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.

Key facts

Study ID

NCT04785300

Run by

Mayo Clinic

People needed

20

Starts

2022-07-06

Expected to finish

2026-12-01

Last updated by the study team

2026-07-17

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• 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.

You may not qualify if…

• 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)
• 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.

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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