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Senolytic
Senolytics for Alzheimer's Disease
Phase 1 & 2
Waitlist Available
Led By Vijay K. Ramanan, MD, PhD
Research Sponsored by Mayo Clinic
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 11 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing a combination of Dasatinib, a cancer drug, and Quercetin, a plant compound, to help people over 55 with memory problems or Alzheimer's disease. The goal is to see if these drugs can safely remove damaged cells in the brain. By doing so, it might slow down or improve the symptoms of Alzheimer's disease. Dasatinib plus quercetin has been previously tested in an early-stage Alzheimer's disease study.
Who is the study for?
This trial is for men and women aged 55 or older with Mild Cognitive Impairment or Alzheimer's, confirmed by brain imaging showing Tau protein. They must not be on certain dementia medications or if they are, the dose should be stable for three months. Participants need a legal representative to consent and attend visits, have no major travel plans for about three months, and meet specific health criteria like adequate blood counts.
What is being tested?
The ALSENLITE study tests the combination of two drugs, Dasatinib and Quercetin, to see if they're safe and can work in people with Mild Cognitive Impairment (MCI) or Alzheimer's disease. The goal is to understand how these drugs affect cognitive impairment associated with Alzheimer's.
What are the potential side effects?
Potential side effects from Dasatinib may include fluid retention, bleeding problems, fatigue, digestive issues; while Quercetin could cause headaches and tingling sensations. Side effects vary between individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 11 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~11 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Safety and Tolerability of 11 week of intermittent D+Q treatment
Side effects data
From 2022 Phase 2 trial • 54 Patients • NCT0302304626%
Febrile neutropenia
17%
Sepsis
9%
Mucositis oral
4%
Upper gastrointestinal hemorrhage
4%
Hypotension
4%
Hypertension
4%
Intracranial hemorrhage
4%
Enterocolitis
2%
Small intestinal obstruction
2%
Lower gastrointestinal hemorrhage
2%
Fungemia
2%
Peripheral motor neuropathy
2%
Typhlitis
2%
Oropharyngeal pain
2%
Multi-organ failure
2%
Abdominal pain
2%
Hypoxia
2%
Kidney infection
2%
Edema limbs
2%
Sinus bradycardia
2%
Gastric hemorrhage
2%
Myocardial infarction
2%
Diarrhea
2%
Fibrinogen decreased
2%
Aspiration
2%
Atrial fibrillation
2%
Delirium
2%
Endophthalmitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Treatment (Chemotherapy)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Dasatinib plus Quercetin Treatment GoupExperimental Treatment2 Interventions
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).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Quercetin
2010
Completed Phase 4
~840
Dasatinib
2012
Completed Phase 3
~2320
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease include cholinesterase inhibitors (e.g., donepezil) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, while NMDA receptor antagonists help regulate glutamate activity to prevent excitotoxicity.
Dasatinib and Quercetin, currently under study, aim to reduce senescent cells, which are dysfunctional cells that accumulate with age and contribute to inflammation and tissue damage. Reducing these cells may alleviate some of the neuroinflammation and cellular dysfunction seen in Alzheimer's Disease, potentially slowing disease progression and improving cognitive function.
Exploring the Potential of Therapeutic Agents Targeted towards Mitigating the Events Associated with Amyloid-β Cascade in Alzheimer's Disease.
Exploring the Potential of Therapeutic Agents Targeted towards Mitigating the Events Associated with Amyloid-β Cascade in Alzheimer's Disease.
Find a Location
Who is running the clinical trial?
Mayo ClinicLead Sponsor
3,353 Previous Clinical Trials
3,061,003 Total Patients Enrolled
James L. Kirkland, MD, PhDLead Sponsor
1 Previous Clinical Trials
55 Total Patients Enrolled
Vijay K. Ramanan, MD, PhDPrincipal InvestigatorMayo Clinic
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Your lab test results are not normal, or a doctor thinks there may be a problem based on your overall health.Your heart's electrical activity (measured by an ECG) shows a QTc interval longer than 450 milliseconds.You have a mental health condition that is not currently under control.You have uncontrolled systemic lupus erythematosus, as determined by a doctor.You regularly drink more than 3 alcoholic drinks per day or more than 21 drinks per week.You have a condition that makes it difficult for your body to absorb nutrients from food.Your kidney function is very low, less than 10 ml/min/1.73 m2.You have been diagnosed with symptomatic probable Alzheimer's disease and have a certain range of scores on memory and mental tests.You are not taking certain medications for memory and thinking problems, or if you are, you have been on a steady dose for at least three months.You have been diagnosed with HIV.You have a current hepatitis B or C infection.You have a serious fungal or viral infection, as determined by a doctor.You are allergic to D or Q.Your diabetes is not well controlled, which means your HbA1c level is higher than 7%.You have had a surgery to reduce the size of your stomach.You have Crohn's disease.You have certain muscle conditions or abnormal levels of calcium, vitamin D, or certain blood tests.Your kidneys are not working well enough, as measured by a test called creatinine clearance.You are taking certain medications to prevent blood clots.You are taking strong blood thinners like Aspirin or Clopidogrel, but may be allowed to take a low dose aspirin if it's necessary for your heart health.Your body mass index (BMI) is between 19 and 50.You have long-term heart problems according to your doctor's assessment.You have a medical condition that makes it hard for you to do the physical tests required for the study.You have severe liver disease with high levels of bilirubin.You have excessive fluid buildup around your lungs, heart, or abdomen that is not being controlled.You have any type of cancer that is growing or has been diagnosed recently, except for non-melanoma skin cancers.You cannot handle taking pills, according to the doctor's decision.You are currently taking certain medications that cannot be stopped safely during the study treatment and for 36 hours after the treatment.People who are 55 years old or older when they join the study.You have evidence of tau buildup in your brain shown by a PET scan.Your blood counts must show enough platelets, hemoglobin, and white blood cells.Even with glasses or hearing aids, you have trouble hearing, seeing, or moving.You have had a heart attack, chest pain, stroke, or temporary stroke-like symptoms in the past 6 months.You have tested positive for COVID-19 in the last 30 days before joining the study.Your liver enzymes (AST/ALT) are more than 2.5 times the normal limit.
Research Study Groups:
This trial has the following groups:- Group 1: Dasatinib plus Quercetin Treatment Goup
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.