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

The University of Alabama at Birmingham

Status and phase

Enrolling

Early Phase 1

Conditions

Parkinson Disease

Treatments

Drug: [F-18]DPA714 administration IV

Study type

Interventional

Funder types

Other

Identifiers

NCT06289582

R24-004

022189 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Enrollment

60 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

Accepts Healthy Volunteers

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.