--- title: Detect early dopamine nerve loss nct_id: NCT07265596 phase: PHASE2 status: RECRUITING sponsor: "Michael J. Fox Foundation for Parkinson's Research" study_type: INTERVENTIONAL canonical_url: "https://parkinsonspathways.com/trial/NCT07265596" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07265596" last_fetched: "2026-05-10T14:02:44.916Z" source: "Parkinson's Pathways (curated)" --- # Detect early dopamine nerve loss **Goal (in five words):** Detect early dopamine nerve loss **Official Title:** Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging) **Trial ID:** [NCT07265596](https://clinicaltrials.gov/study/NCT07265596) ## Key Facts - **Phase:** PHASE2 - **Status:** RECRUITING - **Study Type:** INTERVENTIONAL - **Sponsor:** Michael J. Fox Foundation for Parkinson's Research - **Target Enrollment:** 100 participants - **Start Date:** 2023-10-30 - **Completion Date:** 2027-12 - **Conditions:** Prodromal Parkinsons Disease - **Interventions:** [18F] AV-133 PET Imaging - **Intervention Types:** DRUG ## Summary For Families The goal is to see whether PET scans using [18F] AV-133 can detect early loss of dopamine nerve terminals and track progression in people in the prodromal stage of Parkinson's. The approach uses a radioactive tracer that binds the VMAT2 protein on dopamine nerve terminals, so areas with fewer terminals light up on PET images; the scan is diagnostic and does not treat Parkinson's or change levodopa effects, though certain drugs that affect VMAT2 or dopamine storage can blur the picture, for example tetrabenazine, reserpine, methylphenidate, or amphetamine derivatives. The study is enrolling adults 18 and older who are confirmed prodromal PD participants headed to the PPMI clinical baseline visit and who can give informed consent, with extra rules for women of childbearing potential such as effective contraception and a negative pregnancy test. People on interfering medications or with other medical or psychiatric issues that could affect participation are excluded at the investigator's discretion. ## Eligibility - **Minimum age:** 18 Years - **Sex:** ALL ### Full Criteria ``` Inclusion Criteria: 1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit. 2. Able to provide informed consent. 3. 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-AV-133 * 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-AV-133 on day of PET scan. Exclusion Criteria: 1. Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection. 2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation. ``` ## Locations (8) - Institute for Neurodegenerative Disorders, New Haven, Connecticut, United States _(41.3081, -72.9282)_ - Mackenzee George Clinical Research Coordinator II — (CONTACT) — 475-318-8248 — mgeorge@xingimaging.com - Amy Ruimerman Lead Clinical Research Nurse, LPN — (CONTACT) — 475-318-8208 — aruimerman@xingimaging.com - Neha Prakash, MBBS — (PRINCIPAL_INVESTIGATOR) - University of Pennsylvania, Philadelphia, Pennsylvania, United States _(39.9524, -75.1636)_ - PPMI Call Center — (CONTACT) — 877-525-7764 - Nabila Dahodwala, MD — (PRINCIPAL_INVESTIGATOR) - Toronto Western Hospital, Toronto, Ontario, Canada _(43.7064, -79.3986)_ - PPMI Call Center — (CONTACT) — 877-525-7764 - Connie Marras — (PRINCIPAL_INVESTIGATOR) - Philipps-University of Marburg, Hessen, Germany _(52.0170, 10.7790)_ - Elisabeth Sittig — (CONTACT) — sittig@med.uni-marburg.de - Wolfgang Oertel — (PRINCIPAL_INVESTIGATOR) - Tel Aviv Sourasky Medical Center, Tel Aviv, Israel _(32.0809, 34.7806)_ - Anat Mirelman — (CONTACT) — Bsc972-3-697-3014 — anatmi@tlvmc.gov.il - Roy Alcalay, MD — (PRINCIPAL_INVESTIGATOR) - Radboud University, Nijmegen, Gelderland, Netherlands _(51.8425, 5.8528)_ - Yara Krasowski — (CONTACT) — info@onderzoek-parkinson.nl - Bastiaan Bloem, MD — (PRINCIPAL_INVESTIGATOR) - Queen Mary University of London, London, Britain, United Kingdom _(51.5085, -0.1257)_ - Cristina Simonet — (CONTACT) — 44-02078823379 — c.simonet@qmul.ac.uk - Cristina Simonet, MD — (PRINCIPAL_INVESTIGATOR) - Alastair Noyce, MD — (PRINCIPAL_INVESTIGATOR) - Newcastle University, Newcastle upon Tyne, Tyne and Wear, United Kingdom _(54.9733, -1.6140)_ - Victoria Foster — (CONTACT) — +441912081197 — victoria.foster@ncl.ac.uk - Nicola Pavese — (PRINCIPAL_INVESTIGATOR) - David Ledingham — (SUB_INVESTIGATOR) ## Central Contacts - Lianne Ramia — (CONTACT) — 203-590-5600 — LRamia1@indd.org - Jessica Dimos — (CONTACT) — 203-590-5600 — jdimos@indd.org --- *Canonical: https://parkinsonspathways.com/trial/NCT07265596* *HTML version: https://parkinsonspathways.com/trial/NCT07265596* *Source data: https://clinicaltrials.gov/study/NCT07265596*