Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Hoffmann-La Roche
With
Prothena Biosciences Limited
Age
50–85
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of idiopathic PD based on MDS criteria with bradykinesia plus one of the other cardinal signs of PD (resting tremor, rigidity), without any other known or suspected cause of parkinsonism
On symptomatic PD medication, with stable doses for at least 3 months prior to baseline
A diagnosis of PD for at least 3 months to maximum 3 years at screening
MDS-UPDRS Part IV score of 0 at screening and prior to randomization
Hoehn and Yahr (H\&Y) Stage I or II in OFF medication state at screening and prior to randomization
Dopamine transporter imaging with single photon emission computed tomography (DaT-SPECT) imaging consistent with dopamine transporter deficit, as assessed by the central reader
No anticipated changes in PD medication from baseline throughout the study duration based on clinical status during screening
Willingness and ability to use a smartphone application to measure PD-related symptoms for the duration of the study
Willingness and ability to wear a smartwatch to measure PD-related motor signs
You may not be if
Medical history indicating a Parkinsonian syndrome other than idiopathic PD
Diagnosis of PD dementia
Diagnosis of a significant neurologic disease other than PD
Within the last year, unstable or clinically significant cardiovascular disease
Uncontrolled hypertension
Drug and/or alcohol abuse within 12 months prior to screening, in the investigator's judgment (Nicotine is allowed, Marijuana use is not allowed)
Clinically significant abnormalities in laboratory test results at the screening visit, including hepatic and renal panels, complete blood count, chemistry panel and urinalysis
Allergy to any of the components of prasinezumab, a known hypersensitivity, or a previous IRR following administration of any other monoclonal antibody
Any contraindications to obtaining a brain magnetic resonance imaging (MRI)
