Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Alkahest, Inc.
Age
50–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Diagnosis of clinically established or clinically probable PD according to MDS-PD criteria with at least 1 year of PD symptoms.
Modified Hoehn and Yahr ≤2.5.
Have notable motor worsening during off-medication state.
Clear-cut improvement of motor response to levodopa medications, as assessed by the investigator.
Must be on stable dopaminergic therapy (e.g., levodopa, dopamine agonists, monoamine oxidase inhibitors, catechol-O-methyl transferase inhibitors, amantadine), for at least 8 weeks prior to enrollment and remain on stable dose during the 12-week treatment period.
Female subjects must not be pregnant or breastfeeding. Women of childbearing potential (WOCBP) must have a negative pregnancy test at Screening. WOCBP must agree to use highly effective contraception prior to study entry. Male subjects must be willing to use a barrier method of contraception.
You may not be if
Secondary or atypical parkinsonian syndromes, for example, patients with parkinsonism from encephalitis, metabolic disorders, vascular parkinsonism, drug-induced parkinsonism, multiple system atrophy, corticobasal ganglia degeneration, progressive supranuclear palsy, Lewy body dementia.
History of any brain surgery for PD (e.g., pallidotomy, deep brain stimulation, or fetal tissue transplant).
Conditions affecting the peripheral or central nervous system, unless related to PD, that would affect the ability to adequately perform the MDS-UPDRS and motor assessments: i.e., severe sensory neuropathy affecting arm or leg function, or stroke affecting motor or gait function.
Significant alcohol or drug abuse within past 2 years.
Based on ECG reading, subjects with a risk of QT prolongation.
