Summary

Eligibility
for people ages 40-75 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by David Wilson, MD, PhD (ucsf)
Headshot of David Wilson
David Wilson

Description

Summary

This is a first in human study that will assess the safety and diagnostic performance of [18F]RP-115 (fluorine-18 labeled RP115), a positron emission tomography (PET) agent. This agent has the potential to identify the early changes that occur in the brains of patients with Alzheimer disease.

Official Title

First-in-human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Healthy and Alzheimer's Diseased Brain

Details

Alzheimer's disease (AD) is the leading cause of dementia and represent a growing public health concern with tremendous impact on patients and their families. Early diagnosis of AD is essential. This study aims to develop a novel radiotracer to fill this unmet need. The excitatory amino acid transporter 2 (EAAT2) is the main transporter for glutamate which is primarily located on the astrocytes and is significantly down-regulated in select cerebral regions of AD brain. The goal of this study is to test the EAAT2 targeted positron emitting agent, [18F]Fluoro- fluorenylasparaginate methyl ester ([18F]RP-115), to evaluate both safety as well as the early changes in astrocytes in healthy control versus cognitively impaired Alzheimer patients by quantitative PET imaging of EAAT2. This is a single-center, non-blinded, pilot study. Enrollment of 68 subjects is anticipated. Healthy volunteers will be recruited to determine normal biodistribution of the radiotracer. Alzheimer patients and age-matched controls will be recruited in order to determine the tracer performance. The primary endpoint relates to the safety of the [18F]RP-115 scan. The secondary endpoint relates to acquisition, processing, and comparison of [18F]RP-115 PET data in normal and Alzheimer's diseased brains. The project will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Keywords

Alzheimer Disease Nuclear medicine Positron emission tomography Magnetic resonance imaging [18F]RP-115 PET/MRI

Eligibility

You can join if…

Open to people ages 40-75

  1. Age 40-75 years old
  2. BMI age-suitable
  3. Ability to provide written informed consent and willing to comply with protocol requirements, or has a legal authorized representative/guardian who provides surrogate informed consent.
  4. No apparent physical disorder.
  5. Radial, ulnar or brachial artery suitable for catheterization.
  6. Non- smoker, and not taking over the counter nicotine cessation- to limit peripheral metabolism events
  7. Devoid of central nervous system prescription drugs for three weeks- to limit peripheral metabolism events.

For Cohort 2 part B only:

  1. Must have a study partner (informant) who spends a minimum average of 5 hours per week with the participant (e.g. family member, significant other, friend, caregiver), is generally aware of the participant's daily activities, can provide information about the participant's cognitive and functional performance
  2. Recent (within 6 mo.) mini mental examination clinical scores.

You CAN'T join if...

  1. Unable to provide written informed consent and unwilling to comply with protocol requirements, or does not have a legal authorized representative/guardian who can provide surrogate informed consent.
  2. Inadequate arterial access.
  3. Receipt of radioisotope < 5 half-lives within [18F]RP-115 imaging- as to not confound any scans with radiation background for previous scanning, and unsuitable organ dosimetry thresholds from previous (> two weeks) PET scans.
  4. The performed [18F]RP-115 scan(s) must not represent > 3 PET studies total within one year.
  5. Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia.
  6. Participants who are pregnant (female patients of childbearing age will be tested prior to injection of tracer- positive test excludes from the study)
  7. Participants who are breast-feeding.
  8. Have a medical condition or other circumstances that in the opinion of the project physicians would significantly decrease chances of obtaining reliable data, achieving the study objective or completing the study.

Location

  • China Basin, UCSF accepting new patients
    San Francisco California 94107 United States

Lead Scientist at University of California Health

  • David Wilson, MD, PhD (ucsf)
    David M. Wilson, M.D., Ph.D. received his B.S. degree from Harvard University in Biochemistry, and completed his M.D./Ph.D. training at Columbia University in New York City. His Ph.D. mentor was Dr. Ronald Breslow, a pioneer in artificial enzymes, the hydrophobic effect, and bio-organic chemistry.

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
David Wilson
ID
NCT05374278
Phase
Phase 1 Alzheimer's Disease Research Study
Study Type
Interventional
Participants
Expecting 68 study participants
Last Updated