Enhancing Parasympathetic Activity to Improve Endothelial Dysfunction, Vascular Oxidative Stress in African Americans

Exclusion Criteria22

• Individuals with a history of physician diagnosed myocardial infarction, angina, heart failure, stroke, or transient ischemic attack, or who had undergone an invasive procedure for CVD (coronary artery bypass graft, angioplasty, valve replacement, pacemaker placement or other vascular surgeries)
• Uncontrolled hypertension defined as persistent blood pressure >140/90 despite the use of anti-hypertensive agents.
• Diabetes Mellitus type 1 or type 2, as defined by a fasting plasma glucose of 126 mg/dL or greater hemoglobin A1C (HbA1C) 6.5% or above or the use of anti-diabetic medication
• The use of nitrates.
• The metabolism of galantamine is primarily through the cytochrome P450 system, specifically the CYP2D6 and CYP3A4 isoenzymes. We will exclude subjects who have impaired hepatic function and/or who are currently using strong inhibitors of CYP3A4 and CYP2D6 (e.g. ketoconazole and paroxetine, respectively).
• Pregnancy or breast-feeding. Women of child-bearing potential will be required to have undergone tubal ligation or to be using an oral contraceptive or barrier methods of birth control.
• Post-menopausal women.
• The use of any other central or peripheral acetylcholinesterase inhibitor (donezepil (Aricept(R)), pyridostigmine (Mestinon(R)), rivastigmine (Exelon(R)), tacrine (Cognex(R)).
• First, second or third-degree AV block detected during the screening visit with an ECG
• Seizures or history of seizures.
• Current smokers defined as those who smoked a cigarette in the last 30 days.
• History of recurrent syncope.
• History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack.
• History of cardiac shunts.
• Allergy to eggs or soy.
• Impaired hepatic function (aspartate amino transaminase \[AST\] and/or alanine amino transaminase \[ALT\] >3.0 x upper limit of normal range)
• Impaired renal function test (eGFR<60 mL/min/1.73m2)
• Anemia (hematocrit <34%)
• Ongoing substance abuse.
• Treatment with any investigational drug in the one month preceding the study
• Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
• Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study