Longitudinal TSPO PET Imaging with [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)

Description

The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives * To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers. * To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives * To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes. * To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes * To acquire safety data following injection of \[18F\]DPA-714

Conditions

Parkinson Disease

Study Overview

Study Details

Study overview

The overall goal of this protocol is to investigate \[18F\]DPA-714 binding in prodromal and early manifest Parkinson's Disease (PD) and to determine the baseline and change from baseline in \[18F\]DPA-714 binding in PD participants during a 24-month interval. Primary Objectives * To compare \[18F\]DPA-714 binding in prodromal and manifest PD and healthy volunteers. * To determine the longitudinal change in \[18F\]DPA-714 during a 24-month interval for prodromal and early initially untreated PD participants. Secondary Objectives * To evaluate the correlation between baseline \[18F\]DPA-714 and PPMI clinical and biomarker outcomes. * To evaluate the correlation between the longitudinal change of \[18F\]DPA-714 and PPMI clinical and biomarker outcomes * To acquire safety data following injection of \[18F\]DPA-714

Longitudinal TSPO PET Imaging with [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)

Longitudinal TSPO PET Imaging with [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)

Condition
Parkinson Disease
Intervention / Treatment

-

Contacts and Locations

Birmingham

UAB, Birmingham, Alabama, United States, 35294

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * A prodromal PD and Healthy participant enrolled in PPMI Clinical protocol
  • * A PD participant enrolled in PPMI Clinical protocol who has not started symptomatic treatment at time of enrollment or in the first 2 years of participation.
  • * Able to provide informed consent
  • * Must have screening genetic testing documenting high binder at the at the known TSPO gene polymorphism (rs6971)
  • * Male or Female (Females must meet additional criteria specified below, as applicable)
  • * Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
  • * Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
  • * Females of childbearing potential must not be pregnant, breastfeeding or lactating.
  • * Includes a negative urine pregnancy test prior to injection of \[18F\]DPA-714 on day of PET scan.
  • * Exposure to a total effective dose equivalent of 50 millisievert (mSv) for the whole body, which is the annual limit established by the US Code of Federal Regulations , during the past year.
  • * Any other medical or psychiatric condition or lab abnormality, which in the opinion of the Site Investigator might preclude participation.

Ages Eligible for Study

18 Years to 99 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

University of Alabama at Birmingham,

Jonathan McConathy, MD, PhD, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

David Standaert, MD, PhD, STUDY_DIRECTOR, University of Alabama at Birmingham

Study Record Dates

2027-06