No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 99
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
60 (estimated)
Sponsor
University of Alabama at Birmingham · Other
Who this trial is looking for
This trial is looking for people with early Parkinson's Disease or healthy volunteers. Participants will receive an injection of a PET imaging agent and undergo monitoring over 24 months to assess brain activity related to the disease.
Are You a Good Fit for This Trial?
You may be able to join if
I have been diagnosed with prodromal Parkinson's Disease or am a healthy participant.
I have not started treatment for Parkinson's Disease.
I can provide informed consent.
I have genetic testing showing I am a high binder at the TSPO gene.
I am a female of non-childbearing potential or using effective birth control.
You may not be able to join if
I have had more than 50 millisieverts of radiation exposure in the past year.
I have any medical or psychiatric condition that may prevent me from participating.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 longitudina…
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
Trial Locations
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Status
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 h…
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.
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