Study to Evaluate DNL201 in Subjects With Parkinson's Disease
Status: | Recruiting |
---|---|
Conditions: | Parkinsons Disease |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 30 - 75 |
Updated: | 3/30/2019 |
Start Date: | December 4, 2018 |
End Date: | September 2019 |
Contact: | Project Assistant |
Email: | MaryAnn.Varner@ppdi.com |
Phone: | 919-456-4493 |
A Phase 1b, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Determine the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of DNL201 in Subjects With Parkinson's Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and
pharmacodynamics of multiple oral doses of DNL201 in subjects with Parkinson's disease.
pharmacodynamics of multiple oral doses of DNL201 in subjects with Parkinson's disease.
Inclusion Criteria:
- Body mass index (BMI) between 18 and 35.0 kg/m2, inclusive
- Clinical diagnosis of Parkinson's disease meeting UK Brain Bank criteria and H&Y Stage
I, II, or III.
- sPD subgroup without a LRRK2 mutation; PD LRRK2 subgroup with LRRK2 mutation
- Screening dopamine transporter (DAT) SPECT scan with a DAT deficit consistent with
Parkinson's disease
- Able to hold Parkinson's disease medications 8 hours (overnight) prior to specific
study assessments
Exclusion Criteria:
- Any history of clinically significant asthma, chronic obstructive pulmonary disease,
or emphysema within 5 years of screening, or other clinically significant pulmonary
disease within 6 months of screening
- Abnormal Vitals including Respiratory Rate, Body Temperature, and Blood Pressure
- Pulmonary Function Tests (PFTs) (FVC <60% predicted, FEV1 <50% predicted, FEV1:FVC
ratio <0.6, DLCO <70% predicted)
- Clinically significant neurologic disorder other than Parkinson's disease, including
history of stroke, cognitive impairment, seizure within 5 years of screening, or head
trauma with loss of consciousness within 6 months of screening
- Montreal Cognitive Assessment (MoCA) score of <24 at screening
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