RECRUITING

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

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

Official Title

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

Quick Facts

Study Start:2024-08-14

Study Completion:2027-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06289582

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:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Evan Hudson

CONTACT

205-934-6499

evanhusdon@uabmc.edu

Principal Investigator

Jonathan McConathy, MD, PhD

PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

David Standaert, MD, PhD

STUDY_DIRECTOR

University of Alabama at Birmingham

Study Locations (Sites)

UAB

Birmingham, Alabama, 35294

United States

Collaborators and Investigators

Sponsor: 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

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 Date2024-08-14

Study Completion Date2027-06

Study Record Updates

Study Start Date2024-08-14

Study Completion Date2027-06

Terms related to this study

Additional Relevant MeSH Terms

Parkinson Disease