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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: Recruiting Phase 1 study of Dementia and SAH, sponsored by Duke University.
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. According to ClinicalTrials.gov, the official US trial registry.
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 assess the level of ferritin (Ft) in CSF (CSF withdrawn from ventriculostomy tube), 2.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
Primary Outcome
Concentration of ferritin in the cerebrospinal fluid
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
| Field | Value |
|---|---|
| Enrollment Target | 66 participants |
| Start Date | 2020-10-01 |
| Est. Completion | 2026-10-31 |
| Phase | Phase 1 |
What NCT03754725 shows while recruiting
NCT03754725 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 66 participants, a relatively small participant target, below the 7,723-participant average among 199 other Dementia trials with a reported enrollment target (99% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT03754725's enrollment target sits among peer trials
66 136th of 199 higher than 64 of 199 other Dementia trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Dementia trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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