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. Author manuscript; available in PMC: 2024 May 20.
Published in final edited form as: J Prev Alzheimers Dis. 2023;10(4):633–646. doi: 10.14283/jpad.2023.104

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