Study to Evaluate DNL201 in Subjects With Parkinson's Disease
NCT ID: NCT03710707
Last Updated: 2020-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
29 participants
INTERVENTIONAL
2018-12-04
2019-12-06
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DNL201 low dose
DNL201
Oral repeating dose
DNL201 high dose
DNL201
Oral repeating dose
Placebo
Placebo
Oral repeating dose
Interventions
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DNL201
Oral repeating dose
Placebo
Oral repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Years
80 Years
ALL
No
Sponsors
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Denali Therapeutics Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Maloney MT, Wang X, Ghosh R, Andrews SV, Maciuca R, Masoud ST, Agam M, Caprioli RM, Astarita G, Bondar VV, Chen J, Chiu CL, Davis SS, Ho AC, Nguyen HN, Propson NE, Reyzer ML, Davis OB, Deen MC, Zhu S, Di Paolo G, Vocadlo DJ, Estrada AA, de Vicente J, Lewcock JW, Arguello A, Suh JH, Huntwork-Rodriguez S, Henry AG. LRRK2 kinase activity regulates Parkinson's disease-relevant lipids at the lysosome. Mol Neurodegener. 2025 Aug 6;20(1):89. doi: 10.1186/s13024-025-00880-7.
Joshi D, Kulkarni M, Parekh P, Shah S, Greig NH, Acharya S. Targeting protein kinases in Parkinson's disease: the emerging role of phytoconstituents. Nutr Neurosci. 2025 Jul 18:1-32. doi: 10.1080/1028415X.2025.2531356. Online ahead of print.
Other Identifiers
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DNLI-B-0002
Identifier Type: -
Identifier Source: org_study_id
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