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NCT05386914 · ClinicalTrials.gov registry record · Phase 1
This Study Consists of Two Study Parts Conducted Under a Single IRB. Part I: Short Term ApoE-dependent Cerebral Blood Flow Response to Sirolimus in Cognitively Normal Adults Part II: Short Term ApoE-dependent Cerebral Blood Flow and Lung Perfusion Response to Sirolimus in Cognitively Normal Adults
A Phase 1 study of Healthy Volunteers and Genetic Predisposition to Disease, sponsored by University of Missouri-Columbia.
- Active
- Registry status
- Phase 1
- Development phase
- 205
- Enrollment target
- 1
- Study location
NCT05386914 is a Phase 1 study of Healthy Volunteers and Genetic Predisposition to Disease that is active but no longer recruiting, run by University of Missouri-Columbia. The registered enrollment target is 205 participants, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (57% lower). The trial reports 1 study location across 1 state.
The verdict
NCT05386914, a Phase 1 study of Healthy Volunteers and Genetic Predisposition to Disease, is active but no longer recruiting, sponsored by University of Missouri-Columbia.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 205 participants
- Enrollment target
- 1
- Study location
Study Summary
This study consists of two study parts (Part I and Part II) conducted under a single IRB approval. Individuals that participated in Part I of the study were invited to participate in Part II of the study. Alzheimer's disease is a devastating neurodegenerative disease characterized by accumulation of clumps (also called plaques) and bundles of fibers (also called tangles) in the brain, for which there is currently no cure. Sirolimus is an FDA-approved medication which may improve the blood flow to the brain. Part I: This study is designed to see if sirolimus treatment improves MRI blood flow to the brain in individuals with and without a genetic predisposition to Alzheimer's disease. Part I of this study is complete and no longer enrolling participants. Part II: Ongoing research will expand the genetic predisposition cohort and further explore the drug's impact on the lung perfusion via hyperpolarized xenon-129 gas MRI and the brain-vascular connection. Only subjects who are APOE4 carriers will be enrolled in Part II. Hyperpolarized xenon-129 gas MRI is a non-invasive technique in which a subject inhales a bolus of hyperpolarized xenon-129 gas which can be directly imaged by the MRI as it physiologically distributes itself throughout the lung interior and within tissue and red blood cells. It thus allows for direct imaging and quantification of regional lung function: ventilation, gas-exchange, and perfusion. The relationship between pulmonary vascular function and brain perfusion is largely unstudied. We hope to investigate the relationship between pulmonary vascular function and cerebral blood flow by quantifying both lung and brain perfusion before and after the administration of Sirolimus.
Conditions Studied
Interventions
- DRUG Sirolimus
Study Locations (1)
Missouri
- University of Missouri-Columbia - Columbia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2023-03-02 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05386914
The ClinicalTrials.gov registry entry for NCT05386914 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 205 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (57% lower). The listed sponsor is University of Missouri-Columbia, which has 291 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 1 intervention - of which Sirolimus is the first listed.
NCT05386914 reports 1 study location spanning 1 distinct geographic area - top geographies include Missouri.
Frequently Asked Questions
What is clinical trial NCT05386914 about?
NCT05386914 is a clinical study titled "This Study Consists of Two Study Parts Conducted Under a Single IRB. Part I: Short Term ApoE-dependent Cerebral Blood Flow Response to Sirolimus in Cognitively Normal Adults Part II: Short Term ApoE-dependent Cerebral Blood Flow and Lung Perfusion Response to Sirolimus in Cognitively Normal Adults". This study consists of two study parts (Part I and Part II) conducted under a single IRB approval. Individuals that participated in Part I of the study were invited to participate in Part II of the study. Alzheimer's disease is a devastating neurodegenerative disease characterized by accumulation o...
What is the current status of trial NCT05386914?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 205 participants. The study started on 2023-03-02. Estimated completion is 2027-12.
What conditions does trial NCT05386914 study?
This clinical trial studies the following conditions: Healthy Volunteers, Genetic Predisposition to Disease.
What interventions are being tested in trial NCT05386914?
The interventions under investigation include: Sirolimus (DRUG).
Who is sponsoring clinical trial NCT05386914?
This trial is sponsored by University of Missouri-Columbia, which has 291 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05386914 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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