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Diuretic

Part A; Cohort 3 for Alzheimer's Disease

Phase 1
Waitlist Available
Research Sponsored by NeuroPro Therapeutics, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Able to swallow capsules.
Body mass index (BMI) of 18 to 32 kg/m2, inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe and effective in humans.

Eligible Conditions
  • Alzheimer's Disease
  • Epilepsy

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You can swallow pills.
Select...
Your body mass index (BMI) is between 18 and 32 kg/m2.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (predose) and 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 12, 24, 30, and 36 hours postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with abnormal ECG
Number of participants with abnormal lab test results
Number of participants with abnormal vital signs
+1 more
Secondary outcome measures
Dose proportionality
Pharmacokinetic AUCinf
Pharmacokinetic AUClast
+5 more

Trial Design

6Treatment groups
Experimental Treatment
Group I: Part B; Cohort 3Experimental Treatment1 Intervention
Every 12-hour dosing of 80mg (7 days)
Group II: Part B; Cohort 2Experimental Treatment1 Intervention
Every 12-hour dosing of 40mg (7 days)
Group III: Part B; Cohort 1Experimental Treatment1 Intervention
Every 12-hour dosing of 20mg (7 days)
Group IV: Part A; Cohort 3Experimental Treatment1 Intervention
QD dosing of 160mg (1 day)
Group V: Part A; Cohort 2Experimental Treatment1 Intervention
QD dosing of 50mg (1 day)
Group VI: Part A; Cohort 1Experimental Treatment1 Intervention
QD dosing of 10mg (1 day)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
NPT 2042 (bumetanide analog) or Matching Placebo
2022
Completed Phase 1
~50

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

NeuroPro Therapeutics, Inc.Lead Sponsor

Frequently Asked Questions

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

How many people does the research team plan to recruit for this trial?

"Affirmative. The data on clinicaltrials.gov indicates that the study, which was first made visible to the public on October 20th 2022, is presently recruiting candidates for participation. 48 participants need to be gathered from a single site."

Answered by AI

Would I meet the prerequisites for joining this medical experiment?

"This trial has room for 48 people living with epilepsy and aged between 19 to 55 years old. Eligibility criteria includes a Body Mass Index of 18-32 kg/m2, negative pregnancy test results in females at screening and upon admission, abstinence or contraceptive use during the study duration (90 days after the last dose) plus 90 days post treatment, swallowing pills capability, as well as a minimum body weight of 50kg for males and 45kg for females."

Answered by AI

Does the age requirement of this research extend to those under 25 years of age?

"To meet the criteria of this trial, potential participants must be between 19 and 55 years old. At present, there are 126 trials available for minors while 696 are tailored to those over 65 years old."

Answered by AI

What degree of hazard is associated with Part A; Cohort 3?

"There is scant data to support the safety and efficacy of Part A; Cohort 3, so it earned a score of 1."

Answered by AI

What objectives is this investigation attempting to accomplish?

"The primary goal of this study, which will occur over a span of up to 7 days, is to assess the number of participants with abnormal vital signs. Additionally, researchers are interested in 3 pharmacokinetic variables: apparent volume of distribution during terminal elimination phase (VzF), area under plasma concentration-time curve from zero to last quantifiable (AUClast) and area under plasma concentration-time curve extrapolated to infinity (AUCinf)."

Answered by AI

Are there still openings available for enrollees in this research study?

"Affirmative. Clinicaltrials.gov contains data that demonstrates this clinical trial is actively recruiting patients; the initial posting was on October 20th, 2022 and it has been updated since then. The study seeks to enrol 48 individuals at a single site."

Answered by AI
~21 spots leftby Mar 2025