New trial aims to fix blood vessel damage in african americans
NCT ID NCT04769206
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a drug called galantamine can improve blood vessel function and reduce harmful stress in the blood vessels of African Americans. Researchers will measure changes in blood flow and markers of cell damage over three months. The goal is to find a new way to prevent heart disease in this high-risk group.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2021
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Chaney Johnson
RECRUITINGNashville, Tennessee, 37232, United States
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