Clinical trial NCT06289582: Longitudinal TSPO PET Imaging with [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Official title: Longitudinal TSPO PET Imaging with [18F]DPA-714 in PPMI (PPMI DPA-714 PET Imaging)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Parkinson Disease
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Michael J. Fox Foundation for Parkinson's Research
First posted: 2024-03-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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


Eligibility 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.

Primary outcomes:
measure: Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Jonathan McConathy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: David Standaert, MD, PhD
role: STUDY_DIRECTOR
References: