ALSENLITE: Senolytics for Alzheimer's Disease

NCT04785300 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: 19-003394
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mild Cognitive Impairment; Alzheimer Disease

Outcome Measures

Primary Outcomes (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.

  11 weeks

Study Arms (1)

Dasatinib plus Quercetin Treatment Goup

EXPERIMENTAL

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; Drug: Quercetin

Interventions

Dasatinib DRUG

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

Dasatinib plus Quercetin Treatment Goup

Quercetin DRUG

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

Dasatinib plus Quercetin Treatment Goup

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Publications (2)

• 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.

  PMID: 40009460 DERIVED

• 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.

  PMID: 34366147 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease

Interventions

Dasatinib; Quercetin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Flavonols; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Vijay K. Ramanan, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: March 4, 2021
• First Posted: March 5, 2021
• Study Start: July 6, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 22, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)