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Study to Evaluate DNL201 in Subjects With Parkinson's Disease | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Study to Evaluate DNL201 in Subjects With Parkinson's Disease

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

NCT03710707•Denali Therapeutics Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

30 - 80 years

Sex

ALL

Healthy Volunteers

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

Locations (7)

Clinical Site(s)

Long Beach, California, United States

Clinical Site(s)

Aurora, Colorado, United States

Clinical Site(s)

Miami, Florida, United States

Clinical Site(s)

Orlando, Florida, United States

Clinical Site(s)

Farmington Hills, Michigan, United States

Clinical Site(s)

Philadelphia, Pennsylvania, United States

Clinical Site(s)

Spokane, Washington, United States

Key Dates

Start Date

December 4, 2018

Primary Completion Date

December 6, 2019

Completion Date

December 6, 2019

Last Updated

January 13, 2020

Enrollment

ACTUAL participants

Conditions

Parkinson Disease

Interventions

DNL201

DRUG

Placebo

DRUG

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

NCT06692920

Parkinson Disease

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[18F]F-DOPA Imaging in Patients With Autonomic Failure

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 13, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate DNL201 in Subjects With Parkinson's Disease

Inclusion Criteria

Exclusion Criteria

Characterizing the Pathophysiological Role of the Pallido-thalamocortical Motor Pathway in Parkinson's Disease.

[18F]F-DOPA Imaging in Patients With Autonomic Failure

Montelukast in Parkinson Disease

Exercise for Cognitive Excellence in Parkinson's Disease

The Effect of Functional Rotational Exercises on Fall Risk and Mobility in Parkinson's Disease Patients

SAD Study in Patients With Parkinson's Disease and Motor Fluctuations