[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prodromal-parkinsons-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prodromal-parkinsons-disease":95},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,76],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100636600","gbpdc-gut-brain-in-pd-consortium-master-protocol-100636600",false,"NCT07567794","GBPDC: Gut-Brain in PD Consortium Master Protocol","Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol","GBPDC","Inclusion Criteria (All PD Cohorts)\n\n1. Aged ≥21 years old and ≤80 years old\n2. Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n3. Adequate visual, hearing, cognitive, and physical ability\n4. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a \"best estimate\" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee\n\nInclusion Criteria Controls\n\n1. Aged ≥21 years old and ≤80 years old\n2. No known or diagnosed neurodegenerative disease\n3. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n4. Resides within the same household as person with PD\n\nInclusion Criteria Prodromal Cohort\n\n1. Aged ≥21 years old and ≤80 years old\n2. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.\n\nExclusion Criteria (All Cohorts)\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Laboratory Values:\n\n   1. Hemoglobin (Hgb) \\\u003C10\n   2. Platelets \\\u003C70,000\n   3. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN)\n   4. Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002FBSA \\[body surface area\\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \\[ALP\\] \\>2.0 times the ULN and\u002For total bilirubin \\>2.0 times the ULN)\n   5. Significantly above the normal range for PT\u002FINR\u002FPTT\n3. Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure\n4. Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \\\u003C22\n5. Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed\u002Ftreated vitamin B12 deficiency, or other screening laboratory abnormalities\n6. Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide\n7. Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated\u002Fremoved cutaneous carcinomas are not excluded.)\n8. Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study\n9. Body mass index (BMI) \\>35 kg\u002Fm2 or body weight \\\u003C50 kg\n10. Participant is currently pregnant, breastfeeding, and\u002For lactating\n11. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n12. History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n13. Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment\n14. Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.\n15. History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n16. Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n17. Has a history of Crohn's disease, ulcerative colitis, and\u002For other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and\u002For, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.",true,"ALL","21 Years","80 Years",{"count":22,"type":23},250,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.\n\nDuring this study, specific groups of participants, also known as \"cohorts\", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.\n\nParticipants in this study will:\n\n* meet with a medical provider\n* answer questionnaires\n* give samples of blood, stool, and saliva\n* have X-rays taken while swallowing different foods (swallowing study)\n* have X-rays taken to see how long it takes markers to move through their colon (colon transit study)\n* have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)\n* have samples taken of their skin\n* have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.\n\nParticipation in the study will last up to 24 months (2 years).",[27,28,29,30,31],"Parkinson Disease (PD)","PARKINSON DISEASE (Disorder)","Gut Microbiome","Gut Microbiota","Prodromal Parkinsons Disease",[33,34,35,36],"gut brain","Parkinson's disease","Prodromal Parkinson's disease","healthy control","NOT_YET_RECRUITING","2026-04-29",{"date":40,"type":41},"2026-05-05","ACTUAL",{"date":43,"type":23},"2026-06-04",{"date":45,"type":23},"2028-12-31",{"name":47,"class":48},"Duke University","OTHER",7,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":4,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":18,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":4,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":66,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100613362","phase-2-early-longitudinal-imaging-in-the-parkinsons-progressive-marker-initiative-ppmi-using-18fav-133-ppmi-av-133-prodromal-imaging-100613362","NCT07265596","Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)","Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)","Inclusion Criteria:\n\n1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.\n2. Able to provide informed consent.\n3. Male or Female (females must meet additional criteria specified below as applicable)\n\n   * Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of 18F-AV-133\n\n     * Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).\n     * Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.\n   * Females of childbearing potential must not be pregnant, breastfeeding or lactating.\n\n     * Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of PET scan.\n\nExclusion Criteria:\n\n1. Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection.\n2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.","18 Years",{"count":59,"type":23},100,"INTERVENTIONAL",[62],"PHASE2","The study is a longitudinal, multi-center study to assess progression of \\[18F\\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \\[18F\\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).",[31],"RECRUITING","2025-11-24",{"date":68,"type":41},"2025-12-05",{"date":70,"type":41},"2023-10-30",{"date":72,"type":23},"2027-12",{"name":74,"class":48},"Michael J. Fox Foundation for Parkinson's Research",8,{"id":77,"slug":78,"hasResults":11,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":18,"minAge":84,"maxAge":4,"enrollmentInfo":85,"targetDuration":87,"studyType":24,"phases":4,"briefSummary":88,"conditions":89,"keywords":96,"overallStatus":65,"whyStopped":4,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":104,"completionDateStruct":106,"leadSponsor":108,"locationsCount":110},"100582886","saliva-and-extracellular-vesicles-for-neurodegenerative-diseases-100582886","NCT06869135","Saliva and Extracellular Vesicles for Neurodegenerative Diseases","Novel Method for Diagnosis of Neurodegenerative Diseases Based on Saliva Biochemical Profiling","MINERVA","Inclusion Criteria:\n\n* AD: standard criteria for dementia due to AD with AD neurochemical demonstration.\n* PD: MDS Criteria; modified Hoehn\\&Yahr stages; stable pharmacological treatment (last 4 weeks).\n* AtP: current consensus diagnostic criteria for progressive supranuclear palsy; corticobasal degeneration and multiple system atrophy.\n* prodromic PD: according to diagnostic criteria by Berg;\n* MCI: according to diagnostic criteria by Dubois and Albert.\n\nExclusion Criteria:\n\n* For all the experimental groups considered, subjects with concomitant chronic and \u002F or inflammatory diseases of the oral cavity, other systemic diseases, oncological or infectious diseases will be excluded.\n* Patients not able to provide written informed consent autonomously will be excluded.\n* For PD patients: Vascular, familiar and drug- induced parkinsonism, other known or suspected causes (metabolic, brain tumor etc) or any suggestive features of AtP; dementia with MoCA Test Correct Score\\\u003C15","45 Years",{"count":86,"type":23},242,"12 Months","Early diagnosis of Neurodegenerative diseases (NDDs) and accurate patient profiling are key goals needed to tailor prompt personalized therapeutic strategies that can significantly impact disease progression and patients' quality of life. The project will validate a novel, cost-effective and quick biophotonic-based method for early and differential diagnosis of NDDs (Parkinson's disease, atypical parkinsonisms, Alzheimer's disease) and for routine clinical monitoring of NDD progression (longitudinal study). Raman spectroscopy (RS) will be applied to biochemically profile saliva and salivaderived Extracellular Vesicles (sEVs) and to identify a spectroscopic biomarker for NDDs. Optimized protocols for RS will be used to concomitantly evaluate saliva and sEVs from people with NDDs and to detect salivary changes in the biochemical profile, with special focus on EV-associated components. The accuracy of the method in discriminating NDDs at different disease stages and during disease progression will be verified. A nanotechnology-based biomolecular characterization of saliva and sEV will clarify the involvement of specific pathological molecules in NDDs progression.",[90,91,92,93,94,95],"Neurodegenerative Diseases","Parkinson Disease","Alzheimer Disease","Parkinsonism","Mild Cognitive Impairment (MCI)","Prodromal Parkinson's Disease",[97,98,99,100],"Saliva","Raman Spectroscopy","Extracellular Vesicles","Diagnosis","2025-08-04",{"date":103,"type":41},"2025-08-07",{"date":105,"type":41},"2025-01-24",{"date":107,"type":23},"2027-12-15",{"name":109,"class":48},"Fondazione Don Carlo Gnocchi Onlus",5]