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Study on the Safety of Dasatinib and Quercetin for Patients with Mild Cognitive Impairment or Early Alzheimer's Disease

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for individuals with Alzheimer's Disease or a condition known as amnestic mild cognitive impairment (aMCI), which is an early stage of memory loss. The treatment being tested involves a combination of two medications: Dasatinib and Quercetin. These medications are being investigated for their potential to slow down the progression of Alzheimer's Disease by targeting and removing certain aging cells in the body, a process known as senolytic therapy.

The purpose of the study is to evaluate the safety and feasibility of using this combination of medications over a period of 12 weeks. Participants in the study will be randomly assigned to receive either the combination of Dasatinib and Quercetin or a placebo. The study will monitor the participants' health and any side effects that may occur during the treatment period. Additionally, the study will look at changes in specific markers in the blood that are associated with aging cells, as well as any changes in memory and cognitive function over time.

Participants will undergo regular check-ups and blood tests throughout the study to assess the effects of the treatment. The study aims to provide valuable information on whether this combination of medications can be a safe and effective way to help manage Alzheimer's Disease and related memory impairments. The trial will last for a total of 48 weeks, including follow-up visits after the initial 12-week treatment period.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, you will undergo various assessments to confirm your eligibility. These assessments may include cognitive tests and a review of your medical history.

    A blood sample will be collected to check for specific markers related to the study. You will also be asked to provide written consent to participate in the trial.

  2. Step 2

    Baseline assessments

    Before starting the treatment, baseline assessments will be conducted. These assessments will include cognitive tests and blood tests to measure certain markers.

    These tests will help establish a starting point for evaluating the effects of the treatment over time.

  3. Step 3

    Treatment phase

    You will begin the treatment phase, which lasts for 12 weeks. During this time, you will take two medications: quercetin and dasatinib. Both medications are taken orally in the form of film-coated tablets.

    The dosage and frequency of the medications will be provided by the study team. It is important to follow the instructions carefully and take the medications as directed.

  4. Step 4

    Follow-up visits

    Throughout the 12-week treatment phase, you will have regular follow-up visits. These visits will include assessments to monitor your health and the effects of the treatment.

    Blood samples will be collected at these visits to measure changes in specific markers. You will also be asked about any side effects or changes in your condition.

  5. Step 5

    End of treatment assessment

    At the end of the 12-week treatment phase, a comprehensive assessment will be conducted. This will include cognitive tests and blood tests to evaluate the impact of the treatment.

    The results will be compared to the baseline assessments to determine any changes or improvements.

  6. Step 6

    Long-term follow-up

    After completing the treatment phase, you will enter a long-term follow-up period. This period lasts until week 48 of the study.

    During this time, you will have periodic visits every 12 weeks to monitor your health and any long-term effects of the treatment.

Who can join the trial?

12 criteria

  • Must be **60 years or older** at the start of the study.
  • Must have a **study partner** who agrees to participate throughout the study. This person should have regular contact (about 10 hours per week) with the participant and can provide accurate information about the participant's thinking and daily abilities. The study partner must also give written consent to participate.
  • Must not have any travel plans that would interfere with study visits over the **12 months** of the study.
  • Must **speak Spanish fluently** and have at least **six years of formal education**.
  • Must be **fully vaccinated against COVID-19** with the primary vaccine series (2 doses), with the last dose received at least **30 days** before starting the study. COVID boosters are allowed if scheduled at least **four days** before or after the study medication.
  • Open to **both men and women** of **all ethnicities**.
  • Must have a diagnosis of **amnestic mild cognitive impairment (aMCI)** or **early-stage Alzheimer's Disease (AD)** based on specific criteria.
  • Must have **elevated tau protein** levels, which is a protein found in the brain, as determined by a **cerebrospinal fluid (CSF)** test during screening. Previous CSF test results showing elevated tau are also acceptable.
  • Can be on approved medications for Alzheimer's Disease, such as **donepezil, rivastigmine, or galantamine**, as long as the dose has been stable for at least **three months** before the study starts.
  • Must have **normal blood cell counts** and normal liver and kidney function. Total cholesterol should be less than **240 mg/dl**, and **HbA1c** (a measure of blood sugar levels) should be **7% or less**.
  • **PT/PTT/INR** (tests that measure blood clotting) must be within normal limits.
  • Must be able to provide **written consent** to participate in the study.

Who cannot join the trial?

10 criteria

  • Patients with any other significant medical condition that could interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients with a history of severe allergic reactions to the study medications.
  • Patients who are pregnant or breastfeeding.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who are unable to comply with the study procedures.
  • Patients with unstable or serious medical conditions that could affect their safety or the study results.
  • Patients with a history of cancer within the past five years, except for certain types of skin cancer.
  • Patients with severe liver or kidney disease.
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Investigated drugs

  • Dasatinib

    is a medication that is being tested in this clinical trial to see if it can help with Alzheimer's disease. It is usually used to treat certain types of cancer, but researchers are exploring if it can also help remove damaged cells in the brain that might contribute to Alzheimer's. By doing this, it might slow down the progression of the disease.

  • Quercetin

    is a natural substance found in many fruits and vegetables. In this trial, it is being used alongside dasatinib to see if it can help improve the condition of people with Alzheimer's disease. Quercetin is thought to have properties that might help clear out harmful cells in the brain, potentially slowing down the disease's progression.

What is already known about the treatment

Dasatinib plus Quercetin – This medication is administered orally in the form of tablets and is currently being studied in a Phase II clinical trial for its potential use in treating amnestic mild cognitive impairment and early-stage Alzheimer's Disease. The main therapeutic indication is to assess its safety and feasibility in modulating the progression of Alzheimer's Disease. At the molecular level, dasatinib and quercetin work together as senolytics, which means they help clear out damaged cells that no longer function properly, potentially reducing harmful effects in the brain. This combination falls under the pharmacological classification of senolytic agents, which are being explored for their ability to target aging cells.

Investigated diseases

  • Amnestic Mild Cognitive Impairment (aMCI)

    Amnestic Mild Cognitive Impairment is a condition characterized by noticeable memory problems that are greater than expected for a person's age but do not significantly interfere with daily life. It primarily affects memory, with individuals often experiencing difficulty remembering recent events or conversations. The progression of aMCI can vary, with some individuals remaining stable for years, while others may experience a gradual worsening of memory issues. Over time, aMCI can lead to more significant cognitive decline, potentially progressing to Alzheimer's Disease. The condition is often identified through reports of memory lapses and confirmed by cognitive testing. It is considered a transitional stage between normal aging and more serious conditions like dementia.

  • Alzheimer's Disease

    Alzheimer's Disease is a progressive neurological disorder that leads to the degeneration of brain cells and a decline in cognitive function. It typically begins with mild memory loss and confusion, gradually worsening to include difficulties with language, disorientation, mood swings, and behavioral changes. As the disease advances, individuals may struggle with recognizing family and friends, performing daily tasks, and maintaining personal care. The progression of Alzheimer's Disease is marked by the accumulation of abnormal protein deposits in the brain, leading to the death of brain cells. This results in a continuous decline in memory, thinking, and reasoning skills. The disease is the most common cause of dementia in older adults.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514411-95-00Protocol codeIRB00067429Estimated enrolment48 patientsSponsorWake Forest University Health Sciences

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