Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Active Phase 1 study of Healthy Volunteers and Genetic Predisposition to Disease, sponsored by University of Missouri-Columbia.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Rate of blood perfusion expressed as mL/100g/min globally and regionally
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 |
What the registry record for NCT05386914 still lists
NCT05386914 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 481-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (57% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
Similar trials for Healthy Volunteers
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05386914's enrollment target sits among peer trials
205 43rd of 283 higher than 241 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
Source ClinicalTrials.gov registry export · 2026-08-08
-
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia
RECRUITING · Phase 1
-
A Phase 1 Study to Evaluate the Safety and Pharmacokinetics of ABBV-243 in Healthy Adults.
RECRUITING · Phase 1
-
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of ABBV-277 in Healthy Adult Participants
RECRUITING · Phase 1
-
A Study to Evaluate the Effect of Single Oral Dose of Balinatunfib on Cardiac Repolarization in Healthy Adult Participants.
RECRUITING · Phase 1
-
Classroom Break, Cognition, and Fitness in Elementary School Children
RECRUITING · Phase 1
-
A Study to Assess the Relative Bioavailability of BMS-986435 and Food Effect on the BMS-986435 in Healthy Adult Participants
RECRUITING · Phase 1
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03457493 · 205 participants · Phase 1
The University of Alabama At Birmingham (UAB) Neuroinflammation in Parkinson's Disease-TSPO- Positron Emission Tomography (PET) Substudy
- NCT05134857 · 205 participants · Phase 2
The Zonisamide and Reinforcement for Reducing Alcohol Use (ZARRA) Study
- NCT05181891 · 205 participants · Phase 2
Pharmaceutically-Enhanced Reinforcement for Reduced Alcohol and Smoking
- NCT05283811 · 205 participants · NA
Understanding Prefrontal and Medial Temporal Neuronal Responses to Algorithmic Cognitive Variables in Epilepsy Patients
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI