protocolSection identificationModule nctId: NCT06263010, orgStudyIdInfo id: CIBS-2023-01, briefTitle: Allopregnanolone as a Regenerative Treatment for Parkinson's Disease, acronym: Allo-PD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-12, primaryCompletionDateStruct date: 2024-09, completionDateStruct date: 2024-12, studyFirstPostDateStruct date: 2024-02-16, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Roberta Brinton, class: OTHER, descriptionModule briefSummary: The goal of this open-label, pilot clinical trial is to test allopregnanolone as a regenerative treatment in patients with Parkinson's disease (PD). The main questions this study aims to answer are:1. Is a large-scale clinical trial testing how well it works in patients with PD feasible?2. Is allopregnanolone safe and well-tolerated in patients with PD.3. Can we see any signals of changes in imaging and clinical scales?Participants will receive a weekly infusion in their vein of allopregnanolone for a total of 12 weeks. There is no placebo so everyone receives allopregnanolone and "Open-label" means the study is not blinded so both the participant and investigators know the assigned treatment., conditionsModule conditions: Parkinson Disease, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Allopregnanolone, outcomesModule primaryOutcomes measure: Study completion, secondaryOutcomes measure: Adverse Events, secondaryOutcomes measure: Infusion Reactions, secondaryOutcomes measure: Pharmacokinetics: Peak Plasma Concentration (Cmax), secondaryOutcomes measure: Pharmacokinetics: Time of peak concentration (tmax), secondaryOutcomes measure: Pharmacokinetics: Half-life (t1/2), secondaryOutcomes measure: Pharmacokinetics: Area under the plasma concentration versus time curve (AUC), otherOutcomes measure: Dopamine transporter (DaT) SPECT imaging, otherOutcomes measure: MRI: Regional brain volumes, otherOutcomes measure: MRI: Fractional Anisotropy, otherOutcomes measure: MRI: Quantitative anisotropy, otherOutcomes measure: MRI: Functional connectivity, otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part I (non-motor EDL), otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part II (motor EDL), otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part III (motor examination), otherOutcomes measure: Mean rate of change in the Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score part IV (motor complications), otherOutcomes measure: Mean rate of change in the Unified Dyskinesia Rating Scale (UDysRS) total score, otherOutcomes measure: Change from baseline in Montreal Cognitive Assessment (MoCA) score, otherOutcomes measure: Change from baseline in Parkinson's disease Questionnaire (PDQ-39)., otherOutcomes measure: Change from baseline in Hamilton Depression Rating Scale (HAM-D), otherOutcomes measure: Cambridge Cognition's Paired Associates Learning (PAL) Test, otherOutcomes measure: Cambridge Cognition's Motor Screening Task (MOT), otherOutcomes measure: Cambridge Cognition's One Touch Stockings of Cambridge (OTS), eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The University of Arizona Clinical & Translational Science Research Center, status: RECRUITING, city: Tucson, state: Arizona, zip: 85721, country: United States, contacts name: Dakota Darby, role: CONTACT, email: dakotadarby@arizona.edu, geoPoint lat: 32.22174, lon: -110.92648, hasResults: False