[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"atypical-parkinson-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:atypical-parkinson-disease":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,65,90],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":64},"100576240","phase-2-psilocybin-therapy-for-psychological-distress-in-palliative-patients-100576240",false,"NCT06782724","Psilocybin Therapy for Psychological Distress in Palliative Patients","The Safety and Efficacy of Psilocybin Therapy Compared to Low-dose Control in Reducing Depressive Symptoms in Patients With COPD, ALS, MS, or APD.","PsyPal","Inclusion Criteria:\n\n1. Patient has to be diagnosed with one of the following four conditions, defined as:\n\n   COPD i) Diagnosis by medical specialist ii) Postbronchodilator FEV1\u002FFVC \\\u003C 0,7 and FEV1 \\\u003C80% pred iii) ≥ 40 years old iv) ≥ 10 years smoking\n\n   ALS i) ALS according to Goldcoast criteria (Shefner et al, Clin Neurophysiol, 2020) ii) ALS-FRS-R subscores of minimum 1 in item 2, 3 and 8, subscore of minimum 2 in item 1, 4 and 10 and a subscore of minimum 3 in item 11 and 12\n\n   MS i) Fulfilled diagnostic revised McDonald criteria for MS from 2017 (Thompson et al., 2018) ii) EDSS ≥ 1,0\n\n   APD i) Advanced to Late-Stage Parkinson's Disease - patients with a diagnosis of Parkinson's Disease per the MDS clinical diagnosis criteria with evidence of motor and non-motor fluctuations ii) Diseases in the spectrum of Progressive supranuclear palsy (PSP), fulfilling possible and probable criteria, according to the MDS diagnostic criteria iii) Clinically Established and Clinically Probable Multiple System Atrophy (MSA) according to the MDS diagnostic criteria\n2. Patient meets ICD-10 criteria for major depressive disorder documented through the com-pletion of the mood section of the Mini International Neuropsychiatric Interview by a screen-ing psychologist or physician.\n3. Patient has a MADRS score of \\> 19.\n4. Patient should have a life expectancy of at least 6 months (assessed by study physician).\n5. Patient is at least 18 years of age.\n6. Patient has an identified caregiver\u002Fsupport person. See specific conditions for Czechia in Appendix 5.\n7. Patient is able to read and understand the informed consent and all scales used in a local language. For those with ALS, MS, or APD, competency is ensured via neurologist assessment, cognitive screening, caregiver support during screening and interactive approaches where the screening clinician ask the patient to explain their understanding of consent elements, re-explaining potentially misunderstood information.\n8. Patient is able to and willing to adhere to study requirements, including attending all study visits, preparatory and follow-up sessions, and completing all study evaluations.\n9. Patient is able to ingest capsules.\n\nExclusion Criteria:\n\n1. Patient has used a psychedelic substance in the past 6 months (e.g., psilocybin, LSD, 5-MeO-DMT, DMT, ayahuasca or mescaline).\n2. Patient is in active treatments for other psychiatric disorders, judged by the screening clinician to be a more significant clinical problem than depression \u002F distress.\n3. Patient meets ICD-10 criteria for schizophrenia spectrum or other psychotic disorders, including major depressive disorder with psychotic features (except substance\u002Fmedication-induced or due to another medical condition) or bipolar I\u002FII disorder.\n4. Patients with any lifetime diagnosis of schizophrenia spectrum or other psychotic disorders.\n5. Patient has a first-degree relative with schizophrenia spectrum, bipolar I disorder or other psychotic disorders (expect substance\u002Fmedication-induced or due to another medical condition).\n6. Patients with a pre-existing psychiatric condition judged to be incompatible with safe exposure to psilocybin therapy.\n7. Significant suicide risk as defined by (1) suicidal ideation with intent to act (defined as ≥ 5 on MADRS item 10), (2) suicidal attempts within the past year, or (3) clinical assessment of significant suicidal risk during patient interview.\n8. Patient meets ICD-10 criteria for active\u002Fcurrent alcohol or drug use disorder.\n9. Patient has ongoing treatment with antipsychotic drugs. Any prohibited agents must have been stopped at least 5x the elimination half-life of the specific drug at the time of baseline (see Appendix 1a for Prohibited medications).\n10. Patient is unwilling or unable to pause formal psychotherapy (days 0-42).\n11. Patient has neurological conditions (e.g., intracranial tumour, epilepsy, brain injuries, or other neurological disorders) expected by the PIs to conflict with the treatment \u002F study protocol.\n12. Disease-specific exclusion criteria:\n\n    COPD: Unresolved exacerbation or pulmonary infection within last 4 weeks. ALS: Significant cognitive deficits (MoCa, see below). MS: Significant cognitive deficits (MoCa, see below), epilepsy or radiologically isolated syndrome.\n\n    APD: Dementia (MoCa, see below), or Schwab and England ADL scale with scores \\> 80% in the best functional state.\n13. Cardiovascular conditions: recent stroke (\\\u003C 1 year from signing of ICF), recent myocardial infarction (\\\u003C 1 year from signing of ICF), uncontrolled hypertension (blood pressure \\> 140\u002F90 mmHg), clinically significant arrhythmia within 1 year of signing the ICF, or QTc prolongation exceeding 450ms (males) \u002F 470ms (females).\n14. Patient has moderate to severe hepatic impairment (Child-Pugh score ≥ 7).\n15. Patient has insulin-dependent diabetes or who are taking oral hypoglycaemic agents and have a current risk of hypoglycaemia that would require medical intervention.\n16. Patient has any physical or psychological symptoms, medications, blood test results or clinically significant findings at Screening or Baseline (based on the clinical judgement of clinical\u002Fmedical study personnel) that would make a patient unsuitable for the study.\n17. Patient has an allergy or intolerance to any of the materials contained in either drug product.\n18. Cognitive and Neuropsychological assessment: Patients will be excluded if they score below mean minus 1.5 Standard Deviation according to normative age and scholarity adjusted data on the Montreal Cognitive Assessment (MoCA) assessment.\n19. Recent (2 weeks) change or planned change in antidepressant medication during the intervention.\n20. Women who are pregnant, intend to become pregnant during the study or who are currently nursing, or are unwilling to use Highly Effective Contraceptive Methods","ALL","18 Years",{"count":20,"type":21},108,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The goal of this clinical trial is to evaluate whether psilocybin therapy can effectively treat depression and psychological distress in adult patients with COPD, ALS, MS, or APD who have at least 6 months life expectancy. The main questions it aims to answer are:\n\n* Can psilocybin therapy safely reduce depressive symptoms compared to low-dose control?\n* Will the therapeutic effects be rapid and sustained over a 6-month period?\n\nResearchers will compare patients receiving two escalating doses of psilocybin (15mg followed by 25mg) against those receiving two low doses (1mg) to see if the higher doses lead to greater improvements in depression, anxiety, demoralization, and quality of life.\n\nParticipants will:\n\n* Attend three preparation sessions with psychotherapists (1-2 hours each)\n* Undergo two supervised psilocybin dosing sessions (6-8 hours each)\n* Complete five integration therapy sessions following the dosing sessions\n* Participate in follow-up assessments at 6 weeks, 3 months, and 6 months\n* Have access to a digital care platform and peer support groups during the 6-month follow-up period\n* Optional: Control group participants may receive one high-dose psilocybin session (25mg) after the initial study period",[27,28,29,30,31],"COPD (Chronic Obstructive Pulmonary Disease)","ALS (Amyotrophic Lateral Sclerosis)","MS (Multiple Sclerosis)","Major Depressive Disorder (MDD)","Atypical Parkinson Disease",[33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51],"psilocybin","therapy","palliative","care","palliative care","end-of-life distress","depression","psychological distress","psypal","copd","als","ms","apd","chronic obstructive pulmonary disorder","amyotrophic lateral sclerosis","multiple sclerosis","major depressive disorder","atypical parkinson disease","existential distress","RECRUITING","2026-05-04",{"date":55,"type":56},"2026-05-08","ACTUAL",{"date":58,"type":56},"2025-07-01",{"date":60,"type":21},"2028-01-01",{"name":62,"class":63},"University Medical Center Groningen","OTHER",4,{"id":66,"slug":67,"hasResults":11,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":4,"eligibilityCriteria":71,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":72,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":75,"conditions":76,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":89},"100585738","brain-activity-during-complex-walking-in-people-with-atypical-parkinsonian-syndromes-100585738","NCT06906276","Brain Activity During Complex Walking in People With Atypical Parkinsonian Syndromes","Walking and Thinking - Brain Activity During Complex Walking in Atypical Parkinsonian Syndromes","Inclusion Criteria:\n\n* clinical diagnosis of PSP according to Movement Disorder Society (MDS) (2017) or\n* MSA according to MDS criteria (2022)\n* the ability to walk with or without a mobility device for ≤5 minutes continuously\n\nExclusion Criteria:\n\n* cognitive difficulties affecting the ability to understand and\u002For follow verbal\u002Fwritten - instructions\n* severe freezing of gait\n* Severe hearing or visual impairments that affect participation in the assessments\n* Other neurological diseases\n* Other diseases that can affect gait or balance.",{"count":73,"type":21},30,"OBSERVATIONAL","Every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. However, the process of aging or the sequelae of neurological diseases such as atypical Parkinson's disease (APD) compromises motor-cognitive interaction necessary for an independent lifestyle. While motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions.\n\nThe challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecologically valid state. The investigators aim therefore to explore brain function during complex walking in healthy and APD by investigating the effects of age and neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fNIRS) and advanced gait analysis in real time in older healthy adults and people with APD.",[77,31,78,79],"Gait Disorders, Neurologic","fNIRS","Aging","2025-07-04",{"date":82,"type":56},"2025-07-08",{"date":84,"type":56},"2025-03-14",{"date":86,"type":21},"2027-12-31",{"name":88,"class":63},"Karolinska Institutet",1,{"id":91,"slug":92,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":97,"sex":17,"minAge":18,"maxAge":98,"enrollmentInfo":99,"targetDuration":4,"studyType":74,"phases":4,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":52,"whyStopped":4,"lastUpdateSubmitDate":110,"lastUpdatePostDateStruct":111,"startDateStruct":113,"completionDateStruct":115,"leadSponsor":117,"locationsCount":89},"100285367","gait-analysis-in-neurological-disease-100285367","NCT02994719","Gait Analysis in Neurological Disease","Gait Pattern Analysis in Neurological Disease","Inclusion Criteria:\n\n* Age 18-85 (for both healthy and affected subjects).\n* Presence of at least 2 of the following: bradykinesia, rest tremor, rigidity, postural instability (UK PD Brain Bank Criteria) (Affected subjects only).\n* Montreal Cognitive Assessment will be employed to determine whether subjects will need the assent of a legally authorized representative. Subjects with MOCA ≤ 21 will be consented only with the assent of the subject and informed consent of the authorized legal representative (Affected subjects only).\n* These may include subjects who may have indeterminate parkinsonism, when it is not clear whether they have idiopathic Parkinson's Disease versus one of the Atypical Parkinsonisms, such as Vascular Parkinsonism, Multiple System Atrophy, Progressive Supranuclear Palsy, Normal Pressure Hydrocephalus or Corticobasal Degeneration (Affected subjects only).\n* Subjects with assistive devices will be eligible for the study and may use them during the study (Affected subjects only).\n* Absence of complaints regarding difficulty walking such as arthritic pain, fatigue during walking or slowness of walking (Healthy subjects only).\n\nExclusion Criteria:\n\n* Presence of alternative explanation for parkinsonism such as head trauma, drug-induced parkinsonism (affected subjects only).\n* Currently being treated for major medical illness requiring recent hospitalization (\\\u003C14 days) (for both healthy and affected subjects).\n* Currently participating in another clinical study with an intervention arm (for both healthy and affected subjects).\n* Inability to consent due to cognitive impairment and absence of legally authorized representative (for both healthy and affected subjects).\n* Subjects with any cardiac, pulmonary conditions (congestive heart failure requiring hospitalization within the past 90 days, recent myocardial infarction \\\u003C 90 days, supplemental oxygen-requiring subjects due to cardiac or pulmonary conditions) that limit their ability to safely participate in a walking trial (for both healthy and affected subjects).",true,"85 Years",{"count":100,"type":21},120,"The purpose of this study is to investigate whether speed-dependent measures of gait can be identified in patients with neurological conditions that affect gait, particularly in subjects with parkinsonian disorders.",[103,104,31,105,106,107,108,109],"Parkinson's Disease","Parkinsonian Disorders","Progressive Supranuclear Palsy","Multiple System Atrophy","Corticobasal Degeneration","Gait, Frontal","Huntington Disease","2025-06-05",{"date":112,"type":56},"2025-06-08",{"date":114,"type":56},"2016-03-01",{"date":116,"type":21},"2026-06-20",{"name":118,"class":63},"Beth Israel Deaconess Medical Center"]