The Parkinson's Progression Markers Initiative (PPMI)
This is a observational, multi-center study to assess progression of clinical features, imaging and biologic biomarkers in Parkinson disease (PD) patients compared to healthy controls (HC) and in PD patient subtypes. The primary objective of this study is to identify clinical, imaging and biologic markers of PD progression for use in clinical trials of disease-modifying therapies.
‣ Parkinson Disease (PD) Subjects:
• A diagnosis of Parkinson disease for 2 years or less at Screening.
• Confirmation from imaging core that screening DAT scan is consistent with dopamine transporter deficit, or if applicable a VMAT-2 PET scan consistent with vesicular monoamine transporter deficit.
• Not expected to require PD medication with at least 6 months from Baseline.
• Male or female age 30 years or older at time of PD diagnosis.
‣ Healthy Control (HC) Subjects:
‣ • Male or female age 30 years or older at Screening.
‣ Hyposmia:
⁃ Male or female age 60 years or older
⁃ Confirmation from olfactory core that olfaction as determined by UPSIT is at or below the 10th percentile by age and gender
‣ REM Behavior Disorder (RBD):
⁃ Male or female age 60 years or older
⁃ Confirmation from sleep core that subject's Polysomnography (PSG) meets criteria for RBD
‣ LRRK2:
⁃ Male or female age 60 years or older
⁃ Written confirmation or documentation from testing facility that the individual is LRRK2 mutation positive 4.2.7.2. Confirmation from imaging core that screening dopamine transporter SPECT scan is read as eligible (see below). About 80 subjects will have a range of DAT deficit similar to subjects with early PD (mild to moderate DAT deficit). About 20 subjects will be selected with no DAT deficit or minimal DAT deficit similar in age, gender, and risk profile to those with mild to moderate DAT deficit. 4.2.7.3. Ability to provide written informed consent in accordance with Good Clinical Practice (GCP), International Conference on Harmonization (ICH), and local regulations. 4.2.7.4. Willing and able to comply with scheduled visits, required study procedures and laboratory tests. 4.2.7.5. Women may not be pregnant, lactating or planning pregnancy during the course of the study. Includes a negative urine pregnancy test on day of screening scan prior to injection (DaTSCAN).