[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"prodromal-stage\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:prodromal-stage":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,77,116],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":38,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":76},"100617877","slowing-cognitive-decline-in-alpha-synucleinopathies-by-enhancing-physical-activity-100617877",false,"NCT07324330","Slowing Cognitive Decline in Alpha-synucleinopathies by Enhancing Physical Activity","ALPHA-FIT","Inclusion Criteria:\n\niRBD:\n\n* Age: 50-80 years\n* Polysomnographically confirmed diagnosis of iRBD\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nHealthy controls:\n\n* Age: 50-80 years\n* Maximum of 120 minutes of sports\u002Foutdoor activities per day\n* Less than an average of 10,000 steps per day during the 4-week eligibility and baseline phase\n* Basic smartphone skills\n* Sufficient knowledge of German (native language, C1 or C2)\n* Ownership of a suitable smartphone (minimum screen size 4.6 inches, Android version 9 or iOS version 15 or newer)\n* Consent to be informed of any additional findings\n\nExclusion Criteria:\n\niRBD:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n\nHealthy controls:\n\n* Relevant cardiovascular diseases\n* Problems with dexterity or cognitive impairments that make it difficult to use a smartphone\n* Cognitive impairments that limit the ability to make informed decisions and consent to participate in the study\n* Ownership of one of the following devices: Huawei P8 Lite, Huawei P9 Lite, Xiaomi Mi 6, Huawei P20 Lite (FitBit is not compatible)\n* clinically diagnosed iRBD",true,"ALL","50 Years","80 Years",{"count":21,"type":22},130,"ESTIMATED","INTERVENTIONAL",[25],"NA","α-Synucleinopathies, including Parkinson's disease and dementia with Lewy bodies, are the second most common neurodegenerative diseases. In addition to progressive motor deterioration, cognitive decline is a key element of the non-motor symptom complex of these diseases. Isolated rapid eye movement (REM) sleep behavior disorder (iRBD) indicates an early stage of α-synucleinopathies, even before relevant motor or cognitive disorders are present. Therapeutic interventions in individuals with iRBD therefore have great preventive potential. In particular, increasing physical activity could have a relevant effect on neurodegenerative processes, including the preservation of cognitive functions.\n\nThe aim of the study is therefore to investigate the effects of increased physical activity in everyday life on cognitive functions in individuals with iRBD. In this randomized, double-blind, actively controlled study, an increase in physical activity will be implemented over a period of one year with the help of a motivational smartphone application. The intervention and control conditions are the same as those used in the Slow-SPEED trials, making the connection between the trials concrete. The primary outcome parameter is the change in cognitive performance in a neuropsychological test battery over one year.\n\nEighty individuals with iRBD and 50 age- and gender-matched individuals are being recruited at the University Hospital Bonn and the \"Deutsches Zentrum für Neurodegenerative Erkrankungen\" (DZNE) Bonn (German branch only). In addition to classic neuropsychological tests as the primary endpoint, magnetic resonance imaging (MRI) and blood-based markers of brain aging are being examined as secondary endpoints. This study is in close collaboration with the Slow-SPEED study (https:\u002F\u002Fclinicaltrials.gov\u002Fstudy\u002FNCT06993142). In addition, selected data from three separate trials-Alpha-Fit, Slow-SPEED-NL, and a sister trial in Austria currently in preparation-are planned to be synthesized into a meta-analysis.",[28,29,30,31,32,33,34,35,36,37],"Parkinson Disease","Prodromal Stage","Neurodegenerative Diseases","Basal Ganglia Diseases","Central Nervous System Diseases","Synucleinopathies","Nervous System Diseases","Cerebral Disorder","Brain Diseases","Parkinsonian Disorders",[39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63],"intervention","movement","iRBD","prodromal parkinson's","non-pharmacologic","alpha-synucleinopathy","biomarker","cognitive decline","executive function","MRI","lifestyle","prevention","RCT","motor decline","smartphone","smartwatch","accelerometer","scalable","prodromal","PD","Parkinson","Lewy-body","MSA","multiple system atrophy","dementia","RECRUITING","2026-01-14",{"date":67,"type":68},"2026-01-16","ACTUAL",{"date":70,"type":68},"2025-12-04",{"date":72,"type":22},"2029-12-01",{"name":74,"class":75},"University Hospital, Bonn","OTHER",1,{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":84,"targetDuration":4,"studyType":23,"phases":86,"briefSummary":87,"conditions":88,"keywords":90,"overallStatus":105,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100592416","slow-speed-slowing-parkinsons-early-through-exercise-dosage-100592416","NCT06993142","Slow-SPEED: Slowing Parkinson's Early Through Exercise Dosage","Slow-SPEED","Inclusion criteria\n\n1. previously identified LRRK2 G2019S or GBA N370S variant based on genotyping\n2. aged 50 years or older\n3. able to understand the English language\n4. being able to walk independently inside the home without the use of a walking aid\n5. in possession of a suitable smartphone (screen size minimum 4.6 inch), (Android version 9 or iOS version 15 or newer)\n6. Not in a high physical activity range during the 4-week eligibility and baseline period\n\nExclusion criteria\n\n1. clinically diagnosed or self-reported diagnosis neurodegenerative disease\n2. self-reported falls of three or more per year\n3. dexterity problems or cognitive impairments hampering smartphone use\n4. if they are not aware of and do not wish to be informed about an increased risk of developing diseases associated with the LRRK2 or GBA1 risk variant\n5. if individual is not community-dwelling\n6. in possession of one of the following devices: Huawei P8 Lite; Huawei P9 Lite; Xiaomi Mi 6; Huawei P20 Lite (Fitbit is incompatible)",{"count":85,"type":22},600,[25],"The goal of this clinical trial is two-fold. First to investigate the feasibility of whether a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation over a long period of time (24 months). Second, to explore the preliminary efficacy of exercise on markers for prodromal Parkinson's disease progression in individuals with a LRRK2 G2019S or GBA1 N370S genetic mutation.\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. A joint primary objective consists of two components. First to determine the longitudinal effect of an exercise intervention in LRRK2 G2019S or GBA1 N370S variant carriers on a prodromal load score, comprised of digital biomarkers of prodromal symptoms. The secondary component of the primary outcome is to determine the feasibility of a remote intervention study. The secondary objective is the effect of a physical activity intervention on digital markers of physical fitness. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD. Using these biomarkers, the investigators aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United Kingdom are currently in preparation (Slow-SPEED-UK) and active in the Netherlands (Slow-SPEED-NL). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[28,29,30,31,32,33,34,35,36,37,89],"Genetic Predisposition",[91,92,93,94,95,96,97,98,99,28,100,101,102,103,104],"Physical activity","Prevention","Remote","Mobile Health (mHealth)","Feasibility","Exercise","Digital biomarker","Motivational application","Walking","Prodromal","LRRK2","GBA1","Genetic","Smartwatch","NOT_YET_RECRUITING","2025-05-28",{"date":108,"type":68},"2025-06-03",{"date":110,"type":22},"2025-07-01",{"date":112,"type":22},"2029-06-30",{"name":114,"class":75},"Radboud University Medical Center",2,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":120,"acronym":121,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":123,"targetDuration":4,"studyType":23,"phases":125,"briefSummary":126,"conditions":127,"keywords":129,"overallStatus":64,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":133,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":76},"100530935","slow-speed-nl-slowing-parkinsons-early-through-exercise-dosage-netherlands-100530935","NCT06193252","Slow-SPEED-NL: Slowing Parkinson's Early Through Exercise Dosage-Netherlands","Slow-SPEED-NL","Inclusion Criteria:\n\n* previously diagnosed with iRBD meeting the following criteria according to the International Classification of Sleep Disorders (ICSD-3)\n* able to understand the Dutch language\n* being able to walk independently inside the home without the use of a walking aid\n* Not in a high physical activity range during the 4-week eligibility and baseline period\n* in possession of a suitable smartphone compatible with the Slow-SPEED app, the Fitbit app and the Roche PD Research Mobile application.\n\nExclusion Criteria:\n\n* clinically diagnosed or self-reported diagnosis neurodegenerative disease;\n* self-reported weekly falls in the previous 3 months;\n* dexterity problems or cognitive impairments hampering smartphone use;\n* if they do not wish to be informed about an increased risk of developing diseases associated with iRBD\n* if individual is not community-dwelling\n\nExclusion criteria for MRI only:\n\n* history of epilepsy, structural brain abnormalities (i.e. stroke, traumatic defects, large arachnoid cysts) or brain surgery\n* claustrophobia\n* implanted electrical devices (i.e. pacemaker, deep-brain stimulator (DBS), neurostimulator)\n* metal implants (such as prosthetics, ossicle prosthesis, metal plates or other non-removable metal part) or metal splinters\n* pregnancy\n* fear for incidental finding",{"count":124,"type":22},110,[25],"The goal of this clinical trial is to investigate the feasibility if a remotely administered smartphone app can increase the volume and intensity of physical activity in daily life in patients with isolated Rapid Eye Movement (REM) sleep behaviour disorder over a long period of time (24 months).\n\nParticipants will be tasked to achieve an incremental increase of daily steps (volume) and amount of minutes exercised at a certain heart rate (intensity) with respect to their own baseline level. Motivation with regards to physical activity will entirely be communicated through the study specific Slow Speed smartphone app. Primary outcomes will be compliance expressed as longitudinal change in digital measures of physical activity (step count) measured using a Fitbit smartwatch. Exploratory outcomes entail retention rate, completeness of remote digital biomarker assessments, digital prodromal motor and non-motor features of PD, blood biomarkers and brain imaging markers. Using these biomarkers, we aim to develop a composite score (prodromal load score) to estimate the total prodromal load. An international exercise study with fellow researchers in the United States and United Kingdom are currently in preparation (Slow-SPEED). Our intention is to analyse overlapping outcomes combined where possible through a meta-analysis plan, to obtain insight on (determinants of) heterogeneity in compliance and possible efficacy across subgroups",[28,29,30,37,128,31,32,33,34,35,36],"REM Sleep Behavior Disorder",[130,92,93,94,95,96,97,131,132,48,98,99,28,100],"Physical Activity","Blood","Imaging",{"date":108,"type":68},{"date":135,"type":68},"2024-01-15",{"date":137,"type":22},"2027-12-01",{"name":114,"class":75}]