Quantitative Imaging of Brain Glymphatic Function in Humans

NCT04768101 | Active Not Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: Imaging of Brain Glymphatics
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Parkinson Disease

Outcome Measures

Primary Outcomes (1)

• Diffusion Tensor Imaging Along Perivascular Spaces (DTI-ALPS)

  Using a 3T MRI (body coil transmission and SENSE phased-array 32-channel reception), images will be taken. For analysis, a unitless ratio of diffusion along perivascular space relative to orthogonal to perivascular space at the level of the lateral brain ventricles will be calculated

  baseline, under anesthesia

Study Arms (1)

Parkinson's Disease participants with MCI

EXPERIMENTAL

Patient volunteers will also undergo a C-11 PiB PET scan. This procedure utilizes a common radiotracer that is used routinely in clinical PET scans and will be purchased here from PETNET and certified for human use. All PET scans will be performed by a certified PET technologist at the Vanderbilt University Institute of Imaging Science.

Drug: [11C]-PIB

Interventions

[11C]-PIB DRUG

\[11C\]-PIB is a PET radiotracer used to evaluate levels of Αβ burden.

Also known as: N-Methyl-[ 11C]-2-(4'-methylaminophenyl)-6-hydroxybenzothiasole, [11C]-Pittsburgh Compound B, [ 11C]6-OH-BTA-1

Parkinson's Disease participants with MCI

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• diagnosis of Parkinson's Disease or controls
• willing to participate in PET and MRI imaging

You may not qualify if:

• recent stimulant use
• unstable diabetes
• prior stroke
• claustrophobia
• prior cancer treatment with chemotherapy
• history of traumatic brain injury
• any unstable medical condition

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Parkinson Disease

Interventions

2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Manus J Donahue, Ph.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: There is no masking in this protocol.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology, Psychiatry and Behavioral Sciences, and Radiology and Radiological Sciences

Model Details: There is no masking in this protocol.

Study Record Dates

• First Submitted: February 16, 2021
• First Posted: February 24, 2021
• Study Start: April 15, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 9, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR
• Time Frame: upon request
• Access Criteria: upon request

Locations

US (1)