Table 2.
Inclusion and exclusion criteria for the SToMP-AD Phase II Trial
Inclusion Criteria | Exclusion Criteria |
---|---|
Age 60 years and older at study entry, both sexes, all ethnicities | Body mass index (BMI) > 40 kg/m2 |
Clinical diagnosis of aMCI or early AD as defined by: aMCI: o CDR = 0.5, Memory domain score ≥0.5; o MMSE 24–30 o WMS-R Logical Memory II <11 for ≥ 16 years education, ≤ 9 for 8–15 years education, ≤ 6 for 0=7 years education Early AD: o CDR 0.5 or 1.0 o MMSE 20–30 o WMS-R Logical Memory II ≤ 8 for ≥ 16 years education, ≤ 4 for 8–15 years education, ≤ 2 for 0–7 years education |
Chronic heart failure or QTcF ≥ 450 msec in males and ≥ 460 msec in females |
Elevated tau protein, as determined by CSF Aβ:tau ratio | Magnetic Resonance Imaging (MRI) contraindications |
Ability to provide written consent or be accompanied by a Legally Authorized Representative (LAR) | Any significant neurologic disease other than prodromal or early AD |
Availability of a study partner who agrees to attend all study visits and has at least 10 hours of contact with the participant a week | Current or history of alcohol or substance abuse or dependence within the past 2 years |
Absence of travel plans that would interfere with scheduling visits over the 12 months of study duration | Pregnancy or possible pregnancy |
Normal blood cell counts, coagulation panel, liver and renal function without clinically significant excursions. Total cholesterol <240 mg/dl, HbA1c ≤ 7%. PT/PTT/INR within normal limits. |
Uncontrolled diabetes (HbA1c >7% or the current use of insulin or sulfonylureas) |
FDA-approved medications for AD (e.g., donepezil, rivastigmine, galantamine) are permitted if a stable dose has been maintained for ≥3 months prior to study entry | Poorly controlled BP (systolic BP > 160, diastolic BP > 90 mmHg) |
eGFR < 10 ml/min/1.73 m2 | |
Myocardial infarction, angina, stroke, or transient ischemic attack in the past 6 months | |
Presence of significant liver disease with total bilirubin > 2X upper limit | |
Anticoagulants 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 | |
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) | |
Current medications that induce cellular senescence (i.e. alkylating agents, anthra-cyclines, platins, other chemotherapy) | |
Active cancer treatment within last year | |
Inability to tolerate oral medication | |
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 | |
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 |