RECRUITING

First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in Dementia

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Conditions

Alzheimer DiseaseFrontotemporal DementiaDementiaNuclear medicinePositron emission tomographyMagnetic resonance imaging

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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's disease (AD) and frontotemporal dementia (FTD).

Official Title

First-in-Human Evaluation of an Astrocytic Glutamate Transporter (EAAT2) PET Tracer in the Brains of Healthy Controls and Patients With Dementia.

Quick Facts

Study Start:2021-11-02
Study Completion:2026-07-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05374278

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:40 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age 40-75
  2. 2. Age-suitable BMI
  3. 3. Ability to provide written informed consent and willingly comply with protocol requirements or has a legal authorized representative/guardian who provides surrogate informed consent.
  4. 4. No apparent physical disorder.
  5. 5. Radial, ulnar, or brachial artery suitable for catheterization.
  6. 6. Non-smoker, and not taking OTC nicotine cessation - to limit peripheral metabolism events.
  7. 7. Devoid of CNS prescription drugs for three weeks - to limit peripheral metabolism events.
  8. 8. 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, and will accompany the participant in all study procedure.
  9. 9. Recent (within 6 mo.) MME clinical scores.
  1. 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. 2. Inadequate arterial access.
  3. 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. 4. The performed \[18F\]RP-115 scan(s) must not represent \> 3 PET studies total within one year.
  5. 5. Contra-indication to magnetic resonance, including permanent pacemaker, implantable metallic device, etc.; or severe claustrophobia.
  6. 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. 7. Participants who are breast-feeding.
  8. 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.

Contacts and Locations

Study Contact

David Wilson, MD, PhD
CONTACT
415-514-6229
david.m.wilson@ucsf.edu
Henry Vanbrocklin, PhD
CONTACT
415-353-4569
henry.vanbrocklin@ucsf.edu

Principal Investigator

David Wilson, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, San Francisco

Study Locations (Sites)

China Basin, UCSF
San Francisco, California, 94107
United States

Collaborators and Investigators

Sponsor: David Wilson

  • David Wilson, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, San Francisco

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-11-02
Study Completion Date2026-07-01

Study Record Updates

Study Start Date2021-11-02
Study Completion Date2026-07-01

Terms related to this study

Keywords Provided by Researchers

  • Alzheimer Disease
  • Nuclear medicine
  • Positron emission tomography
  • Magnetic resonance imaging
  • Frontotemporal Dementia

Additional Relevant MeSH Terms

  • Alzheimer Disease
  • Frontotemporal Dementia
  • Dementia