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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06289582
• Other study ID #: R24-004
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: June 2024
• Est. completion date: June 2027

Study information

• Verified date: February 2024
• Source: University of Alabama at Birmingham
• Contact: Evan Hudson
• Phone: 205-934-6499
• Email: evanhusdon[@]uabmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: June 2027
• Est. primary completion date: June 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Drug:
• [F-18]DPA714 administration IV
brain PET/MRI imaging after [F-18]DPA-714 administration

Locations

Country	Name	City	State
United States	UAB	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Michael J. Fox Foundation for Parkinson's Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD.	The changes over time in neuroinflammation based on TSPO will be assessed by comparing TSPO-PET imaging at baseline, 12 months and 24 months after enrollment.	24 months