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

Обзор

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

Вмешательства

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

Первичные конечные точки

• Measure baseline and follow up regional brain TSPO levels using [18F]DPA-714-PET in prodromal PD. [Срок оценки: 24 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

США · 1 центр

• UAB — Birmingham

Идентификаторы

NCT: NCT06289582 · IRB-300012051 R24-004 · 022189

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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