Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)

Conditions

• Prodromal Parkinsons Disease

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• [18F] AV-133 PET Imaging — DRUG
  Prodromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months. These participants will undergo imaging assessments with \[18F\]AV-133 under this protocol at baseline, 12-month and 24 months.

Study Details

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).

Key Dates

Start date

Oct 30, 2023

Status verified

Nov 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2027

Study Design

Enrollment

100 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Arms

• Experimental: Prodromal Parkinson's disease (PD)
  Prodromal Parkinson's disease participants enrolled in the PPMI Clinical 002 study will receive 3 injections of \[18F\] AV-133 and imaging procedures over the course of 24 months.

Primary Outcome Measure

[18F]AV-133 mean rate of change and variability [ Time Frame: 24 months ]

Central Contacts

• Lianne Ramia
  203-590-5600
  [email protected]
• Jessica Dimos
  203-590-5600
  [email protected]

Locations (2)

Find similar trials in New Haven, CT

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