BridgeMD
Senolytic Therapy to Modulate the Progression of Alzheimer's Disease (SToMP-AD)
EU CTIS ID: 2024-514411-95-00
What this study is testing
Assess the safety and feasibility of 12 weeks of treatment with senolytics (dasatinib plus quercetin) compared with placebo in adults with aMCI or early-stage AD with elevated tau per CSF and determine effects on key blood markers of cellular senescence.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Ages 60 years and older at study entry
- 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. The study partner must provide written consent for their own participation.
- Participants must have no travel plans that would interfere with scheduling visits following consent over the 12 months of study duration
- Must speak Spanish fluently and have at least six years of formal education
- Participants must be fully vaccinated against COVID-19 (2 doses) with the primary vaccine series 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.
- Both sexes
You likely can't join if
- Body mass index (BMI)>40 kg/m2
- eGFR < 10 ml/ min/ 1.73 m2.
- Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6 months.
- Chronic heart failure.
- Presence of significant liver disease with total bilirubin >2X upper limit.
- Inability to tolerate oral medication.
See the full eligibility criteria
Who can join
- Ages 60 years and older at study entry
- 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. The study partner must provide written consent for their own participation.
- Participants must have no travel plans that would interfere with scheduling visits following consent over the 12 months of study duration
- Must speak Spanish fluently and have at least six years of formal education
- Participants must be fully vaccinated against COVID-19 (2 doses) with the primary vaccine series 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.
- Both sexes
- All ethnicities
- Diagnosis of aMCI or early AD per the following criteria: a. aMCI, i. CDR 0.5, Memory Box score ≥ 0.5, ii. MMSE 24-30, iii. WMS-IV Logical Memory II < 11 for ≥16 years education, ≤ 9 for 8-15 years education, ≤ 6 for 0-7 years education (exceptions to cutoffs may be allowed on a case-by-case basis upon review and adjudication by the study investigators), b. Early AD, i. CDR 0.5 or 1.0, ii. MMSE 20-30, iii. WMS-IV Logical Memory II ≤ 8 for ≥16 years education, ≤ 4 for 8-15 years education, ≤ 2 for 0-7 years education (exceptions to cutoffs may be allowed on a case-by-case basis upon review and adjudication by the study investigators)
- 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.
- 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 baseline visit.
- 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%.
- PT/PTT/INR within normal limits
- Participants must have the ability to provide written consent
What rules you out
- Body mass index (BMI)>40 kg/m2
- eGFR < 10 ml/ min/ 1.73 m2.
- Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6 months.
- Chronic heart failure.
- Presence of significant liver disease with total bilirubin >2X upper limit.
- Inability to tolerate oral medication.
- Subjects 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).
- Subjects currently taking drugs that induce cellular senescence: alkylating agents, anthracyclines, platins, or other chemotherapy.
- Subjects 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.
- Subjects 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.
- Concomitant use of strong CYP3A4 inhibitors (see list in section 5.5).
- Average QTcF (from 3 ECGs obtained at least one minute apart) at screening of ≥450msec in males and ≥460msec in females
- 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.
- 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.
- Use of anti-amyloid therapies (e.g. aducanumab, lecanamab)
- MRI contraindications including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker.
- Pregnancy or possible pregnancy
- 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.
- Current or history of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria)
- Endorsement of current suicidality or suicidal ideation on the screening C-SSRS
- Uncontrolled diabetes (HbA1c >7% or the current use of insulin or sulfonylureas)
- 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
The study team makes the final eligibility decision.
Where it's taking place
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.