Study to Evaluate DNL201 in Subjects With Parkinson's Disease

Denali Therapeutics

Status and phase

Completed

Phase 1

Conditions

Parkinson Disease

Treatments

Drug: DNL201

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03710707

DNLI-B-0002

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

30 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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