[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609552":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":11,"studyPopulation":11,"armGroups":45,"interventions":56,"overallOfficials":65,"centralContacts":69,"locations":75,"responsibleParty":112,"collaborators":11,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":11,"eligibilityCriteria":120,"healthyVolunteers":116,"sex":121,"minAge":122,"maxAge":123,"enrollmentInfo":124,"targetDuration":11,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":133,"overallStatus":78,"whyStopped":11,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":148,"completionDateStruct":150,"leadSponsor":152,"locationsCount":153},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":15,"otherOutcomes":11},[9,13],{"measure":10,"description":11,"timeFrame":12},"Occurrence of Treatment-Emergent Adverse Events (TEAEs)",null,"Through Week 80",{"measure":14,"description":11,"timeFrame":12},"Severity of TEAEs",[16,19,21,23,25,27,29,32],{"measure":17,"description":11,"timeFrame":18},"Concentration of alpha (a)-synuclein protein in CSF","Through Week 48",{"measure":20,"description":11,"timeFrame":18},"Change from baseline in concentration of a-synuclein protein in CSF",{"measure":22,"description":11,"timeFrame":18},"Concentration of ALN-SNCA in plasma",{"measure":24,"description":11,"timeFrame":18},"Concentration of major metabolites in plasma",{"measure":26,"description":11,"timeFrame":18},"Concentration of ALN-SNCA in CSF",{"measure":28,"description":11,"timeFrame":18},"Concentration of major metabolites in CSF",{"measure":30,"description":11,"timeFrame":31},"Fraction [fc] of ALN-SNCA excreted in urine","Over 24 hours",{"measure":33,"description":11,"timeFrame":31},"Fc of major metabolites excreted in urine",{"allocation":35,"interventionModel":36,"interventionModelDescription":11,"primaryPurpose":37,"observationalModel":11,"timePerspective":11,"maskingInfo":38},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":39,"maskingDescription":11,"whoMasked":40},"QUADRUPLE",[41,42,43,44],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[46,51],{"label":47,"type":48,"description":11,"interventionNames":49},"ALN-SNCA Dose Escalation","EXPERIMENTAL",[50],"Drug: ALN-SNCA",{"label":52,"type":53,"description":11,"interventionNames":54},"Matching Placebo","PLACEBO_COMPARATOR",[55],"Drug: Placebo",[57,62],{"type":58,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"DRUG","ALN-SNCA","Administered per the protocol",[47],{"type":58,"name":63,"description":60,"armGroupLabels":64,"otherNames":11},"Placebo",[52],[66],{"name":67,"affiliation":5,"role":68},"Clinical Trial Management","STUDY_DIRECTOR",[70],{"name":71,"role":72,"phone":73,"phoneExt":11,"email":74},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",[76,90,100],{"facility":77,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":11},"The Ottawa Hospital - Civic Campus","RECRUITING","Ottawa","Ontario","K1Y 4E9","Canada","CA",{"type":85,"coordinates":86},"Point",[87,88],-75.69812,45.41117,{"lat":88,"lon":87},{"facility":91,"status":78,"city":92,"state":93,"zip":94,"country":82,"countryCode":83,"cosmosGeoPoint":95,"geoPoint":99,"contacts":11},"Montreal Neurological Institute and Hospital","Montreal","Quebec","H3A 2B4",{"type":85,"coordinates":96},[97,98],-73.58781,45.50884,{"lat":98,"lon":97},{"facility":101,"status":78,"city":102,"state":103,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":111,"contacts":11},"Center for Human Drug Research","Leiden","South Holland","2333 CL","Netherlands","NL",{"type":85,"coordinates":108},[109,110],4.49306,52.15833,{"lat":110,"lon":109},{"type":113,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100609552","phase-1-first-in-human-study-of-aln-snca-in-adult-participants-with-early-parkinsons-disease-pd-100609552",false,"NCT07216066","First-in-Human Study of ALN-SNCA in Adult Participants With Early Parkinson's Disease (PD)","First-in-Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Ascending Doses of Intrathecally Administered ALN-SNCA in Participants With Early Parkinson's Disease","Key Inclusion Criteria:\n\n1. Diagnosis of Parkinson's disease according to the Movement Disorder Society (MDS) criteria, as assessed by the investigator, with bradykinesia plus at least one of the other cardinal signs of Parkinson's disease (resting tremor, rigidity), without any other known or suspected cause of Parkinsonism\n2. A diagnosis of Parkinson's disease for 4 years or less at the screening visit\n3. Participant must meet one of the following criteria:\n\n   1. Currently not receiving any standard-of-care (SoC) therapy for Parkinson's disease, has not been on oral dopaminergic therapy (ie, levodopa, dopamine agonists, or Monoamine Oxidase B \\[MAO-B\\] inhibitors) prior to dosing, and is not anticipated to require SoC therapy for Parkinson's disease within approximately 6 months following dosing, or\n   2. Has been on a stable regimen of oral dopaminergic therapy for at least 3 months prior to dosing and is not anticipated to require dose adjustments within approximately 6 months following dosing\n4. BMI ≤35 kg\u002Fm\\^2 at time of screening visit\n\nKey Exclusion Criteria:\n\n1. Medical history indicating a Parkinsonian syndrome other than Parkinson's disease, as defined in the protocol\n2. Clinically significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological, psychiatric or neurological disease (excluding Parkinson's disease) that, as assessed by the investigator, may confound the results of the study or pose an additional risk to the participant during study participation\n3. Medical history of brain or spinal disease\u002Finjury that would interfere with the Lumbar Puncture (LP) procedure or CSF circulation, as defined in the protocol\n4. Any contraindications to undergo a brain Magnetic Resonance Imaging (MRI)\n5. An established allergy or intolerance to lidocaine anesthetic, as defined in the protocol\n6. History of intolerance to Intrathecal (IT) injection(s)\n7. Current history of bleeding diatheses that would increase risk of bleeding upon LP\n8. Has undergone gene therapy, cell therapy or surgical treatment, including deep brain stimulation, for Parkinson's disease\n\nNOTE: Other Protocol-defined Inclusion\u002FExclusion Criteria Apply","ALL","50 Years","80 Years",{"count":125,"type":126},46,"ESTIMATED","INTERVENTIONAL",[129],"PHASE1","This study is researching an experimental drug called ALN-SNCA (called \"study drug\"). The study is focused on people with early Parkinson's disease, a disorder of the nervous system that affects movement. Parkinson's disease is caused by a gradual loss of nerve cells in the brain, especially those due to the harmful build-up of a protein called α-synuclein.\n\nThe aim of the study is to see if the study drug is safe and tolerated well enough to continue testing it in future studies and what side effects may happen from taking the study drug.\n\nThe study is looking at several other research questions, including:\n\n* Whether the study drug can lower the level of α-synuclein protein in the Cerebrospinal Fluid (also referred to as \"CSF\", the fluid that surrounds the brain and spinal cord)\n* How much study drug is in the blood, urine, and CSF at different times",[132],"Parkinsons Disease",[134,135,136,137,138,139,140,141,142,143],"Early Parkinsons disease","Motor and non-motor brain systems","Bradykinesia plus","Resting tremor","Rigidity","Postural instability","Cognitive impairment","Mood disorders","Sleep disturbances","Autonomic dysfunction","2026-09-16",{"date":146,"type":147},"2026-09-21","ACTUAL",{"date":149,"type":147},"2025-12-05",{"date":151,"type":126},"2029-06-07",{"name":5,"class":6},3]