Quantitative Imaging of Brain Glymphatic Function in Humans
Brain fluid flow imaging in Parkinson's patients
Plain English Summary
Quantitative Imaging of Brain Glymphatic Function in Humans is a Phase 1 clinical trial sponsored by Vanderbilt University Medical Center studying Parkinson Disease. This trial tests a new way to see how fluid moves in the brain using special MRI scans. It is for adults diagnosed with Parkinson's disease or healthy adults for comparison. Participation involves undergoing MRI scans and potentially a PET scan with a tracer. Currently, there are no standard imaging tests to directly measure this specific brain fluid flow. The trial aims to enroll 140 participants.
Official Summary
Recent immunological and physiological studies have provided evidence in support of a central nervous system (CNS) lymphatic drainage system in vertebrate animals, and preliminary evidence has suggested that a similar system exists in humans. If operative, this system may have central relevance to many vascular and fluid clearance disorders such as stroke, multiple sclerosis, Parkinson's disease, and Alzheimer's disease related dementia (ADRD): diseases which represent some of the most pressing healthcare challenges of the 21st century. Evaluating this possibility will require improved, robust imaging methods sensitive to lymphatic drainage dysfunction; as such, the goal of this work is to apply novel magnetic resonance imaging approaches, optimized already for evaluating lymphatic circulation in patients with peripheral lymphatic dysfunction, to quantify relationships between physiological hallmarks of ADRD and CNS lymphatic function in humans.
Who Can Participate
Here is what you need to know about eligibility for this trial. People diagnosed with Parkinson's disease or healthy individuals can join. You must be willing to undergo PET and MRI scans. Individuals with recent stimulant use, unstable diabetes, or a history of stroke are not eligible. Those with claustrophobia, prior chemotherapy, or traumatic brain injury may not be able to participate. This trial is studying Parkinson Disease, so participants generally need a confirmed diagnosis.
What They're Measuring
The primary outcome measures how well fluid moves along specific pathways in the brain, which could indicate how well the brain is clearing waste products. The specific primary outcome measures are: Diffusion Tensor Imaging Along Perivascular Spaces (DTI-ALPS) (baseline, under anesthesia). These endpoints are how researchers determine whether the treatment is effective and will form the basis of any future regulatory submissions.
About This Phase
This trial is in Phase 1, the first major stage of clinical testing. Phase 1 trials typically involve 20-100 participants and focus on safety, dosage levels, and side effects. The primary goal is not to test whether the treatment works but to establish that it is safe enough for further testing. About 70% of Phase 1 drugs advance to Phase 2. If successful, the treatment will proceed to Phase 2 efficacy testing.
Why This Trial Matters
This trial investigates a potential new way to understand brain fluid drainage, which could lead to better treatments for diseases like Parkinson's, Alzheimer's, and stroke. This research targets Parkinson Disease, where improved treatment options are needed.
Investor Insight
This early-phase trial explores a novel imaging technique for a critical but understudied area of brain health, potentially opening new diagnostic avenues for neurodegenerative diseases. Phase 1 trials have approximately a 10% chance of eventually gaining FDA approval.
Is This Trial Right for Me?
Ask your doctor if this imaging technique is right for you and what the scans involve. You will need to undergo MRI scans, and possibly a PET scan using a radioactive tracer. The scans will be done at Vanderbilt University Medical Center in Nashville, Tennessee. The trial is being conducted at 1 site. Always discuss clinical trial participation with your healthcare provider before making any decisions. This information is for educational purposes only and is not medical advice.
AI-generated analysis for educational purposes only. This is not medical advice. Discuss clinical trial participation with your doctor. Data sourced from ClinicalTrials.gov.
Study Design
- Study Type: INTERVENTIONAL
- Allocation: NA
- Model: SINGLE_GROUP
- Masking: NONE
- Enrollment: 140 participants
Interventions
- DRUG: [11C]-PIB — \[11C\]-PIB is a PET radiotracer used to evaluate levels of Αβ burden.
Primary Outcomes
- Diffusion Tensor Imaging Along Perivascular Spaces (DTI-ALPS) (baseline, under anesthesia)
Full Eligibility Criteria
Inclusion Criteria: * diagnosis of Parkinson's Disease or controls * willing to participate in PET and MRI imaging Exclusion Criteria: * recent stimulant use * unstable diabetes * prior stroke * claustrophobia * prior cancer treatment with chemotherapy * history of traumatic brain injury * any unstable medical condition
Trial Locations
- Vanderbilt University Medical Center, Nashville, Tennessee, United States
Frequently Asked Questions
What is clinical trial NCT04768101?
NCT04768101 is a Phase 1 INTERVENTIONAL study titled "Quantitative Imaging of Brain Glymphatic Function in Humans." It is currently active, not recruiting and is sponsored by Vanderbilt University Medical Center. The trial targets enrollment of 140 participants.
What conditions does NCT04768101 study?
This trial investigates treatments for Parkinson Disease. The primary condition under study is Parkinson Disease.
What treatments are being tested in NCT04768101?
The interventions being studied include: [11C]-PIB (DRUG). \[11C\]-PIB is a PET radiotracer used to evaluate levels of Αβ burden.
What does Phase 1 mean for NCT04768101?
Phase 1 trials are the first stage of testing a new treatment in humans. They focus on safety, dosage, and side effects, usually involving 20-100 healthy volunteers or patients.
What is the current status of NCT04768101?
This trial is currently "Active, Not Recruiting." It started on 2020-04-15. The estimated completion date is 2026-12-31.
Who is sponsoring NCT04768101?
NCT04768101 is sponsored by Vanderbilt University Medical Center. The sponsor is responsible for funding, designing, and overseeing the clinical trial.
How many people can participate in NCT04768101?
The trial aims to enroll 140 participants. The trial status is active, not recruiting.
How is NCT04768101 designed?
This is a interventional study, uses na allocation, follows a single_group design, employs none masking.
What are the primary outcomes being measured in NCT04768101?
The primary outcome measures are: Diffusion Tensor Imaging Along Perivascular Spaces (DTI-ALPS) (baseline, under anesthesia). These are the main endpoints researchers use to determine whether the treatment is effective.
Where is NCT04768101 being conducted?
This trial is being conducted at 1 site, including Nashville, Tennessee (United States).
Where can I find official information about NCT04768101?
The official record for NCT04768101 is available on ClinicalTrials.gov at https://clinicaltrials.gov/study/NCT04768101. This government database provides the most up-to-date and detailed information about the trial.
What is NCT04768101 testing in simple terms?
This trial tests a new way to see how fluid moves in the brain using special MRI scans. It is for adults diagnosed with Parkinson's disease or healthy adults for comparison.
Why is this trial significant?
This trial investigates a potential new way to understand brain fluid drainage, which could lead to better treatments for diseases like Parkinson's, Alzheimer's, and stroke.
What are the potential risks of participating in NCT04768101?
The main risks are associated with MRI scans, such as claustrophobia or discomfort from lying still. There are minimal risks associated with the PET tracer, similar to other medical imaging procedures. Some individuals may experience anxiety or discomfort during the imaging process. As with any clinical trial, participants are closely monitored and can withdraw at any time.
Should I consider participating in NCT04768101?
Ask your doctor if this imaging technique is right for you and what the scans involve. You will need to undergo MRI scans, and possibly a PET scan using a radioactive tracer. The scans will be done at Vanderbilt University Medical Center in Nashville, Tennessee. Always discuss clinical trial participation with your healthcare provider to determine if it is appropriate for your specific situation.
What does NCT04768101 signal from an investment perspective?
This early-phase trial explores a novel imaging technique for a critical but understudied area of brain health, potentially opening new diagnostic avenues for neurodegenerative diseases. This is a Phase 1 trial, which is in early development stages.
What happens if the treatment in this trial doesn't work?
Participation involves undergoing MRI scans and potentially a PET scan with a tracer. Participants in clinical trials always have the right to withdraw and pursue alternative treatments. The study team will help transition patients to other available options.
Related Conditions
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This analysis is AI-generated and does not constitute medical advice. Always consult your healthcare provider before making decisions about clinical trial participation.