[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"pd\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:pd":84},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,44],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100607997","phase-1-a-clinical-study-to-evaluate-the-safety-and-tolerability-of-bbm-p002-in-the-treatment-of-parkinsons-disease-100607997",false,"NCT07195825","A Clinical Study to Evaluate the Safety, and Tolerability of BBM-P002 in the Treatment of Parkinson's Disease","A Single-arm, Open-label, Single-dose Clinical Study to Evaluate the Safety and Tolerability of BBM-P002 for Stereotactic Bilateral Putamen Injection in the Treatment of Idiopathic Parkinson's Disease","Inclusion Criteria:\n\n1. Participants with a diagnosis of Parkinson's disease for ≥ 5 years.\n2. The Hoehn-Yahr staging meets the requirements during the OFF periods.\n3. The MDS-UPDRS Part III score met the requirements during the OFF periods. the levodopa challenge test was positive\n4. During the screening period, participants were required to take the same stable dose of dopamine-releasing drugs (such as levodopa) regularly\n5. The participants agreed to postpone the neurosurgical procedures related to the indication treatment during the main study phase\n6. The participants agreed not to participate in any other therapeutic intervention studies during the trial period\n7. The participants agreed not to receive the vaccine during the main study phase\n8. From the screening period until at least 52 weeks after dosing, use a reliable contraceptive method\n9. The participants had good compliance and were able to undergo regular follow-ups. During the follow-up period, they were able to accurately complete the diary cards. Family members, guardians or caregivers could assist the subjects in filling out the diary cards\n10. Voluntarilyvoluntarily participated in the study and signed the informed consent form\n\nExclusion Criteria:\n\n1. Atypical or secondary Parkinsonism\n2. Have contraindications for surgery or have previously undergone brain surgery\n3. The participants has an abnormal brain MRI suggestive of brain pathology other than Parkinson's disease\n4. Those with severe cognitive impairments\n5. Those with severe depression or severe anxiety\n6. Abnormal liver function\n7. Abnormal coagulation function\n8. Abnormalities in infectious disease screening\n9. Currently undergoing antiviral treatment for hepatitis\n10. Suffering from unstable or severe diseases in the cardiovascular, respiratory, digestive, nervous, hematological, immune and other systems\n11. Suffering from malignant tumors or having a history of tumors\n12. Previous history of severe allergies\n13. Exclude those who have participated in other clinical trials within the past three months\n14. Had received gene therapy during the screening period\n15. Select those who have received stem cell treatment within the past 12 months\n16. Exclude those who have used other investigational drugs within the past 4 weeks\n17. During the screening period, if the individual had received live vaccines within the previous 2 months, or had a history of vaccination within the last 30 days, they would be excluded.\n18. Having a history of alcohol dependence or drug addiction\n19. Pregnant or lactating female participants\n20. The situations that were determined by the investigator to be unsuitable for inclusion in the study","ALL","40 Years","70 Years",{"count":20,"type":21},18,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The purpose of the study is to evaluate the safety and tolerability of BBM-P002 for stereotactic injection to treat participants with idiopathic Parkinson's Disease (PD) during the dose-limiting toxicity (DLT) observation period.",[27],"PD",[27,29,30],"gene therapy","Adeno-Associated Virus","RECRUITING","2026-01-27",{"date":34,"type":35},"2026-01-28","ACTUAL",{"date":37,"type":35},"2025-12-27",{"date":39,"type":21},"2031-12-30",{"name":41,"class":42},"Shanghai Xinzhi BioMed Co., Ltd.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":63,"overallStatus":74,"whyStopped":4,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":43},"100501530","ipaces-v3-mci-nia-protocol-copied-for-ipaces-v4-pd-ninds-100501530","NCT05810454","iPACES v3 MCI NIA Protocol Copied for iPACES v4 PD NINDS","Neuro-exergaming for the Prevention and Remediation of Decline Due to Parkinson's Disease: Clinical Trial of the Interactive Physical and Cognitive Exercise System (iPACES-PD)","iPACES-PD","Inclusion Criteria:\n\n1. 50 years of age or older\n2. meets criteria for MCI (per site staff\u002FMD\u002Fneuropsychologist and confirmed by study-administered Montreal Cognitive Assessment; MoCA; score = between 16-26, non-inclusive; Milani, 2018)\n\n4\\. available for participation for one year (tablet surveys, videoconference evaluations) 5. willing and able to exercise 3-5 times per week for at least 6 months 6. can pedal an under-table elliptical 7. can read off of a small tablet screen 8. proficient in English (speaking and reading for completion of interview, surveys, game); Spanish language option anticipated soon 9. can participate in testing and read and operate tablet touch screen (adequate hearing, vision, speech) 10. written approval from primary care physician and cardiologist (if applicable) to participate in exercise for this study 11. can provide informed consent\n\nExclusion Criteria:\n\n1. already exercising at recommended levels (45 min of moderate intensity aerobic exercise 5-7x\u002Fwk)\n2. significant history of cardiovascular problems\n3. significant history of stroke\n4. significant history of memory problems (e.g., dementia\u002FAlzheimer's)\n5. significant history of other neurological condition (e.g., seizures, etc.)\n6. significant uncontrolled tremor such that would interfere with touch-screen use required throughout the study (surveys, game-play, etc.)\n7. not prone to cybersickness (e.g., \"car sickness\" or problems with \"screen time\")\n8. cannot provide informed consent (i.e., when phone screened with the Impaired Decision Making Capacity screen)",true,"50 Years",{"count":55,"type":21},120,[57],"NA","The primary purpose of this study is to attempt to replicate and extend promising pilot findings regarding the cognitive benefits of in-home neuro-exergaming with iPACES (interactive Physical and Cognitive Exercise System v3) for persons with mild cognitive impairment (MCI), to evaluate effects for persons with Parkinson's Disease (PD). Participants will include persons with PD, and potentially, also their co-residing partner, who will exercise at home or accessible location, 3-5 times per week for at least 6 months, with follow-up one month after the main intervention. All participation is \"remote\" (completed at home, or location of choice), utilizing either one's own equipment (\"bring-your-own-devices\" BYODs: pedaler, phone\u002Ftablet, smart-watch) or some equipment which may be supplied by the grant-funded study and shipped directly to the home; all study measures are completed remotely (e.g., via phone app, website, biometric device, videoconference, email, snail mail, etc.).",[60,27,61,62],"Parkinson's Disease","Mild Cognitive Impairment","MCI",[64,65,66,67,68,69,70,71,72,73],"Parkinson","exercise","exergame","physical activity","neuro-exergaming","neuropsychological","cognitive","dual-task","interactive","executive function","NOT_YET_RECRUITING","2023-04-11",{"date":77,"type":35},"2023-04-12",{"date":79,"type":21},"2023-08",{"date":81,"type":21},"2026-08",{"name":83,"class":42},"iPACES LLC",""]