Can 'Zombie Cell' cleaners fight Alzheimer's? new trial tests idea
NCT ID NCT04685590
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This phase 2 trial is testing whether a combination of two drugs, dasatinib and quercetin, is safe and feasible for people with early-stage Alzheimer's or mild cognitive impairment. The drugs aim to clear aging 'senescent' cells that may contribute to brain damage. 48 participants aged 60 and older are receiving either the drug combo or a placebo for 12 weeks, with follow-up for up to 48 weeks.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Dasatinib and Quercetin (a drug combination that targets aging cells)
- What this could lead to
- If it works, this could point toward a new way to slow or stop early Alzheimer's by clearing aging cells from the brain.
- What could go wrong
- This is a small, early-phase trial focused on safety, not proof of effectiveness. The treatment may not improve symptoms or could cause side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Dec 2021
- Expected to finish
-
Jan 2029
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
60 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Ages 60 years and older at study entry 2. Both sexes 3. All ethnicities 4. Diagnosis of amnestic mild cognitive impairment (aMCI) or early Alzheimer's disease (AD) 5. Elevated tau protein as determined by CSF performed during screening. Evidence of elevated tau from previously available CSF samples will also be allowed for eligibility determination. 6. FDA-approved medications for AD (e.g. donepezil, rivastigmine, galantamine) are permitted as long as the participant has been maintained on a stable dose for at least three months prior to study entry. 7. Labs: Normal blood cell counts, normal liver and renal function without clinically significant excursions as determined by coordinating center Medical Monitor. Total cholesterol \<240 mg/dl, HbA1c ≤ 7%. 8. Prothrombin Time (PT)/Partial Thromboplastin Time (PTT)/International Normalized Ratio (INR) within normal limits. 9. Participants must have the ability to provide written consent or be accompanied by a Legally Authorized Representative designated to sign informed consent (if determined not to have decision capacity). 10. Participants must have a study partner who agrees to participate throughout the duration of the study. The study partner must have frequent and sufficient contact (approximately 10 hours per week) with the participant and be able to provide accurate information regarding the participant's cognitive and functional abilities. 11. Participants must have no travel plans that would interfere with scheduling visits following consent over the 12 months of study duration. 12. Must speak English fluently and have at least six years of formal education. 13. Participants must be fully vaccinated against COVID-19 with the primary vaccine series per CDC recommendations, with any dose of the vaccine received at least 30 days prior to initiation of the study drug. COVID boosters are allowed during study intervention period when scheduled at least four days before or after administration of the investigational product. Exclusion Criteria: 1. Body mass index (BMI)\>40 kg/m2. 2. Average QTcF (from 3 ECGs obtained at least one minute apart) at screening of ≥450msec in males and ≥460msec in females. 3. MRI contraindications including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker. 4. Pregnancy or possible pregnancy. 5. Any significant neurologic disease other than prodromal or early AD including Parkinson's disease, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. 6. Current or history of alcohol or substance abuse or dependence within the past 2 years per Diagnostic and Statistical Manual of Mental Disorders (DSM V criteria). 7. Endorsement of current suicidality or suicidal ideation on the screening C-SSRS. 8. Uncontrolled diabetes (HbA1c \> 7% or the current use of insulin or sulfonylureas). 9. Poorly controlled blood pressure (systolic BP\>160, diastolic BP\>90 mmHg) based on two or more readings and as determined by the PI/study clinician. 10. eGFR \< 10 ml/ min/ 1.73 m2. 11. Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6 months. 12. Chronic heart failure. 13. Presence of significant liver disease with total bilirubin \>2X upper limit. 14. Inability to tolerate oral medication. 15. Participants taking medications that are sensitive to substrates or substrates with a narrow therapeutic range for CYP3A4, CYP2C8, CYP2C9, or CYP2D6 or strong inhibitors or inducers of CYP3A4 (e.g., cyclosporine, tacrolimus, or sirolimus). 16. Participants currently taking drugs that induce cellular senescence: alkylating agents, anthracyclines, platins, other chemotherapy. 17. Participants on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.) other than low dose aspirin unless able to be held for 2 days prior to LP and with the documented approval of the prescribing clinician. 18. Participants taking H2 antagonists or proton pump inhibitors who are unable or unwilling to reduce or hold therapy for at least 2 days prior to and during each of the 2-day courses of Dasatinib plus quercetin dosing. Instead, subjects may use antacids prior to and during each of the 2-day courses of Dasatinib plus quercetin dosing. 19. Concomitant use of strong CYP3A4 inhibitors. 20. Co-enrollment in another ADRD research study with a potentially disease-modifying intervention or study drug that may impact senescent cells. Participants previously enrolled in a study meeting these criteria are eligible to screen after a washout period of ≥6 months from date of last dose to date of screening. 21. 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. 22. Use of anti-amyloid therapies (e.g. aducanumab, lecanamab).
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Alzheimer disease, early onset are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
FISEVI Clinical Site
Seville, Spain
-
Fundación ACE Clinical Site
Barcelona, Spain
-
Hospital Clínic de Barcelona Site
Barcelona, Spain
-
Sant Pau Clinical Site
Barcelona, Spain
-
Wake Forest Health Sciences
Winston-Salem, North Carolina, 27157, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Walking memory tests may reveal early Parkinson's clues
- Can tango rewire the brain? dance program tested for Parkinson's and dementia
- Can tiny bursts of baduanjin exercise sharpen a fading memory?
- Can pool workouts plus brain games sharpen memory in aging veterans?
- Can home exercise keep older adults with cognitive frailty on their feet?
- A new roadmap to predict Alzheimer's before memory fails