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Cholinesterase Inhibitor

Galantamine for Endothelial Dysfunction

Phase 1 & 2
Recruiting
Led By Cyndya Shibao, MD
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
African American women and men
Age 18 to 60 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to 3 months
Awards & highlights

Study Summary

This trial will study whether the drug galantamine can help improve markers of endothelial cell dysfunction in African Americans.

Who is the study for?
This trial is for African American men and women aged 18 to 60 with a BMI over 28. It's not suitable for those with liver or kidney issues, anemia, diabetes, certain medication use, pregnancy, substance abuse, uncontrolled hypertension, serious heart conditions or neurologic diseases.Check my eligibility
What is being tested?
The study tests if galantamine can reduce oxidative stress and improve endothelial function in African Americans over three months. Participants will be compared to a placebo group to see if there are changes in blood markers and vascular reactivity.See study design
What are the potential side effects?
Galantamine may cause side effects like nausea, headaches, dizziness and gastrointestinal problems. Since it affects the nervous system, it might also lead to more serious effects such as heart problems or seizures in susceptible individuals.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am an African American woman or man.
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I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to 3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
FMD
NADPH activation in PBMC

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: GalantamineExperimental Treatment1 Intervention
Galantamine 16mg/day - titrating: 4mg once a day for 2 weeks, titrate to 8mg once a day for 2 weeks, then 8mg twice a day for 8 more weeks
Group II: PlaceboPlacebo Group1 Intervention
placebo (micro crystalline cellulose) - 1 pill once daily for 4 weeks, then 2 pills daily for 8 weeks
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Galantamine
2007
Completed Phase 4
~4520

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor
853 Previous Clinical Trials
670,980 Total Patients Enrolled
2 Trials studying Endothelial Dysfunction
196 Patients Enrolled for Endothelial Dysfunction
Cyndya Shibao, MDPrincipal Investigator - Vanderbilt University Medical Center
Vanderbilt University Medical Center
7 Previous Clinical Trials
889 Total Patients Enrolled
1 Trials studying Endothelial Dysfunction
26 Patients Enrolled for Endothelial Dysfunction

Media Library

Galantamine (Cholinesterase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT04769206 — Phase 1 & 2
Endothelial Dysfunction Research Study Groups: Galantamine, Placebo
Endothelial Dysfunction Clinical Trial 2023: Galantamine Highlights & Side Effects. Trial Name: NCT04769206 — Phase 1 & 2
Galantamine (Cholinesterase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04769206 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What additional experiments have been conducted involving Galantamine?

"Currently, 3 clinical trials for Galantamine are underway. None of these studies have progressed to Phase 3 yet. Nashville is the epicentre of this research with 4 sites currently running experiments on the medication's efficacy."

Answered by AI

Is the age eligibility for this trial greater than 20 years old?

"This clinical trial is open to participants between 18 and 60 years of age. For younger or older patients, there are 4 studies designed for the former group and 33 trials specifically tailored to those over 65."

Answered by AI

What medical conditions do physicians commonly utilize Galantamine to treat?

"Galantamine is an approved medical intervention for mild dementia of the alzheimer's type, as well as Alzheimer's disease and AD."

Answered by AI

Am I eligible to take part in this medical research?

"This clinical trial is seeking 88 individuals aged 18 to 60 who have been diagnosed with endothelial dysfunction. Other requirements include a BMI over 28 and an age range of 18-60 years old."

Answered by AI

How many participants are involved in this clinical trial?

"Affirmative. Clinicaltrials.gov confirms that this research effort, initially posted on December 20th 2021, is actively recruiting participants for the trial. 88 people need to be enrolled from 2 distinct clinical sites."

Answered by AI

Is enrollment currently open for this clinical investigation?

"As seen on clinicaltrials.gov, this medicinal examination is currently searching for participants and was initially published on December 20th 2021. The trial details have been revised most recently as of December 22nd 2021."

Answered by AI
~48 spots leftby Dec 2026