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NCT03754725 · ClinicalTrials.gov registry record · Phase 1

Ferritin and Iron Burden in SAH sIRB

A Phase 1 study of Dementia and SAH, sponsored by Duke University.

Recruiting
Registry status
Phase 1
Development phase
66
Enrollment target
2
Study locations

NCT03754725 is a Phase 1 study of Dementia and SAH that is actively recruiting participants, run by Duke University. The registered enrollment target is 66 participants, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (99% lower). The trial reports 2 study locations across 2 states.

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The verdict

NCT03754725, a Phase 1 study of Dementia and SAH, is actively recruiting participants, sponsored by Duke University.

RECRUITING
Registry status
Phase 1
Development phase
66 participants
Enrollment target
2
Study locations

Study Summary

Ruptured cerebral aneurysms lead to subarachnoid hemorrhage (SAH),that has a high morbidity and mortality rate, the severity of which is predicted by the "Hunt-Hess grade" (HHG). SAH leads to iron (Fe) and hemoglobin (Hb) accumulation in the brain, which is toxic for neurons. Ferritin (iron reported in the brian) and iron overload leads to brain atrophy, specifically in the mesial temporal lobe (hippocampus, impairing patients' cognition. It is estimated that 50% of survivors have cognitive deficits. Most of the survivors of SAH could not return to work. Iron chelation therapy has been recently gaining ground as a therapeutic intervention in intraparenchymal hemorrhage and in SAH. However, there has not been any study that assess the iron deposition in the brain and the level of ferritin in the cerebrospinal fluid of SAH patients. The investigators propose to conduct a randomized trial using Deferiprone (oral chelating agent, "De") + standard of care versus standard of care in patient with SAH to: 1. assess the level of ferritin (Ft) in CSF (CSF withdrawn from ventriculostomy tube), 2. assess functional outcomes measured by the Montreal Cognitive Assessment (MoCA) score, a score used to assess the level of dementia, mainly in Alzheimer disease patients. 3. quantify the the total iron deposition in the brain based on MRI

Conditions Studied

Dementia SAH

Interventions

  • DRUG Deferiprone pill
  • DRUG placebo
  • BEHAVIORAL Montreal Cognitive Assessment

Study Locations (2)

Iowa

  • Univesity of Iowa Hospital and Clinics - Iowa City

North Carolina

  • Duke University Health System - Durham

Trial Details

FieldValue
Enrollment Target 66 participants
Start Date 2020-10-01
Est. Completion 2026-10-31
Phase Phase 1

Sponsor

Duke University

1,725 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03754725

The ClinicalTrials.gov registry entry for NCT03754725 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 66 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (99% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.

The record links to 2 conditions, with Dementia appearing as the primary indexed condition, and to 3 interventions - of which Deferiprone pill is the first listed.

NCT03754725 reports 2 study locations spanning 2 distinct geographic areas - top geographies include Iowa, North Carolina.

Frequently Asked Questions

What is clinical trial NCT03754725 about?

NCT03754725 is a clinical study titled "Ferritin and Iron Burden in SAH sIRB". Ruptured cerebral aneurysms lead to subarachnoid hemorrhage (SAH),that has a high morbidity and mortality rate, the severity of which is predicted by the "Hunt-Hess grade" (HHG). SAH leads to iron (Fe) and hemoglobin (Hb) accumulation in the brain, which is toxic for neurons. Ferritin (iron reporte...

What is the current status of trial NCT03754725?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 66 participants. The study started on 2020-10-01. Estimated completion is 2026-10-31.

What conditions does trial NCT03754725 study?

This clinical trial studies the following conditions: Dementia, SAH.

What interventions are being tested in trial NCT03754725?

The interventions under investigation include: Deferiprone pill (DRUG), placebo (DRUG), Montreal Cognitive Assessment (BEHAVIORAL).

Who is sponsoring clinical trial NCT03754725?

This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03754725 being conducted?

This trial has 2 study locations across Iowa, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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