Improving blood vessel function in African Americans using galantamine

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to enhance parasympathetic activity to improve endothelial dysfunction and reduce vascular oxidative stress in African Americans. Participants will receive either galantamine or a placebo for three months, with assessments of endothelial cell function and oxidative stress markers. The study will measure changes in vascular reactivity in response to ischemia, focusing on the role of NADPH oxidase and inflammatory mediators. The research addresses the higher cardiovascular disease risk in African Americans by targeting underlying mechanisms of endothelial dysfunction.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. African American women and men
2. Age 18 to 60 years old
3. BMI \>28

Exclusion Criteria:

1. 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)
2. Uncontrolled hypertension defined as persistent blood pressure \>140/90 despite the use of anti-hypertensive agents.
3. 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
4. The use of nitrates.
5. 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).
6. 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.
7. Post-menopausal women.
8. The use of any other central or peripheral acetylcholinesterase inhibitor (donezepil (Aricept(R)), pyridostigmine (Mestinon(R)), rivastigmine (Exelon(R)), tacrine (Cognex(R)).
9. First, second or third-degree AV block detected during the screening visit with an ECG
10. Seizures or history of seizures.
11. Current smokers defined as those who smoked a cigarette in the last 30 days.
12. History of recurrent syncope.
13. History of serious neurologic disease such as cerebral hemorrhage, stroke, or transient ischemic attack.
14. History of cardiac shunts.
15. Allergy to eggs or soy.
16. Impaired hepatic function (aspartate amino transaminase \[AST\] and/or alanine amino transaminase \[ALT\] \>3.0 x upper limit of normal range)
17. Impaired renal function test (eGFR\<60 mL/min/1.73m2)
18. Anemia (hematocrit \<34%)
19. Ongoing substance abuse.
20. Treatment with any investigational drug in the one month preceding the study
21. Mental conditions rendering a subject unable to understand the nature, scope and possible consequences of the study
22. Inability to comply with the protocol, e.g. uncooperative attitude, inability to return for follow-up visits, and unlikelihood of completing the study

Where it's running

• Chaney Johnson
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Cyndya Shibao, MD — Vanderbilt University Medical Center
• Study coordinator: Cyndya Shibao, MD
• Email: cyndya.shibao@vumc.org
• Phone: 615-936-4584

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.