NCT07265596 Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)
| NCT ID | NCT07265596 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Michael J. Fox Foundation for Parkinson's Research |
| Condition | Prodromal Parkinsons Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-10-30 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2023-10-30 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study is a longitudinal, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \[18F\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).
Eligibility 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.
Contact & Investigator
Ken Marek, MD
PRINCIPAL INVESTIGATOR
Institute for Neurodegenerative Disorders
Frequently Asked Questions
Who can join the NCT07265596 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Prodromal Parkinsons Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07265596 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07265596 currently recruiting?
Yes, NCT07265596 is actively recruiting participants. Contact the research team at LRamia1@indd.org for enrollment information.
Where is the NCT07265596 trial being conducted?
This trial is being conducted at New Haven, United States, Philadelphia, United States, Toronto, Canada, Hessen, Germany and 4 additional locations.
Who is sponsoring the NCT07265596 clinical trial?
NCT07265596 is sponsored by Michael J. Fox Foundation for Parkinson's Research. The principal investigator is Ken Marek, MD at Institute for Neurodegenerative Disorders. The trial plans to enroll 100 participants.
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