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NCT06289582 | RECRUITING | Parkinson Disease

Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Sponsor:

University of Alabama at Birmingham

Information provided by (Responsible Party):

Jonathan E McConathy

Brief Summary:

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

Condition or disease

Parkinson Disease

Intervention/treatment

[F-18]DPA714 administration IV

Phase

EARLY_PHASE1

Study Type : INTERVENTIONAL
Estimated Enrollment : 60 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Actual Study Start Date : 2024-08-14
Estimated Primary Completion Date : 2028-06
Estimated Study Completion Date : 2028-06

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 99 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion 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)
  • • Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of \[18F\]DPA-714
  • * 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.
Exclusion Criteria
  • * 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.
Longitudinal TSPO PET Imaging With [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)

Location Details

NCT06289582

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Locations

RECRUITING

United States, alabama

UAB

Birmingham, alabama, United States, 35294