[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"amyloid\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:amyloid":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,53,83,114,136],{"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":31,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":42,"startDateStruct":45,"completionDateStruct":47,"leadSponsor":49,"locationsCount":52},"100642012","phase-2-a-study-of-donanemab-ly3002813-in-participants-with-early-cognitive-decline-trailblazer-alz-7-100642012",false,"NCT07589595","A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)","A Phase 2 Randomized, Placebo-Controlled Clinical Trial to Assess the Safety and Efficacy of Donanemab in Participants With Early Cognitive Decline, at Least One Core Clinical Feature of Dementia With Lewy Bodies, and Confirmation of Alpha-Synuclein and Amyloid Co-pathology","Inclusion Criteria:\n\n* Have gradual and progressive cognitive decline for greater than or equal to ( ≥) 6 months.\n* Have least 1 core clinical feature of dementia with Lewy bodies (DLB).\n* Have a score ≥20 on Montreal Cognitive Assessment (MoCA).\n* Meet plasma P-tau217 criteria.\n* Have a cerebrospinal fluid (CSF) result consistent with the presence of brain amyloid pathology.\n* Have a CSF result consistent with the presence of alpha-synuclein pathology.\n* Have at least 1 reliable study partner who will provide written informed consent to participate, is in frequent contact with the participant, and is familiar with overall function and behavior, such as day-to-day activities and cognitive abilities.\n\nExclusion Criteria:\n\n* Have a disease or condition that could interfere with this study or is a current serious or unstable illness.\n* Have, or is suspected to have, a significant neurological disease (other than the studied condition) that affects the central nervous system and may affect the individual's cognition or ability to complete the study.\n* Have a history of cancer that, in the investigator's opinion, has a high risk of recurrence and preventing the completion of the study.\n* Have clinically significant multiple or severe drug allergies, significant atopy, or severe posttreatment hypersensitivity reactions.\n* Have previously received amyloid-targeting therapy.\n* Active immunization against amyloid-beta.\n* Have a centrally read MRI that does not meet study entry criteria.\n* Have contraindication to MRI or PET scans.\n* Have any contraindication to lumbar puncture.","ALL","55 Years","85 Years",{"count":20,"type":21},350,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The main purpose of this study is to evaluate whether treatment with donanemab slows the progression of cognitive (how we think, learn, remember, pay attention, and make decisions) and functional (how we are able to perform daily activities) decline. For each participant, the study will last one and a half years.",[27,28,29,30],"Cognitive Dysfunction","Lewy Body Disease","Synucleinopathies","Amyloid",[32,33,34,35,36,37,38,39,27],"Mild Cognitive Impairment","Mild Dementia","Brain Diseases","Nervous System Diseases","Neurodegenerative Diseases","Neurocognitive Disorders","Cognition Disorders","Alzheimer Disease","RECRUITING","2026-06-16",{"date":43,"type":44},"2026-06-17","ACTUAL",{"date":46,"type":44},"2026-05-20",{"date":48,"type":21},"2028-08",{"name":50,"class":51},"Eli Lilly and Company","INDUSTRY",72,{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":16,"minAge":62,"maxAge":18,"enrollmentInfo":63,"targetDuration":4,"studyType":22,"phases":65,"briefSummary":67,"conditions":68,"keywords":4,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":82},"100449927","early-phase-1-time-in-bed-restriction-in-older-adults-with-sleep-difficulties-with-and-without-risk-for-alzheimers-disease-100449927","NCT05138848","Time-in-bed Restriction in Older Adults With Sleep Difficulties With and Without Risk for Alzheimer's Disease","Slow-wave Sleep Enhancement in Those at Risk for Alzheimer's Disease: Links With Memory, Excitotoxicity, and Plasma A-beta","ALPS","Inclusion Criteria:\n\n1. Age 65-85.\n2. Self-report mean sleep efficiency (the time in bed spent asleep within the time of lights out to final awakening) \\\u003C 90% based on diary and actigraphy estimates and wake time after sleep onset \\> 20 minutes based on diary and actigraphy estimates.\n3. Self-reported normal or corrected-to-normal visual and auditory acuity.\n\nExclusion Criteria:\n\n1. Shift work involving night shift or regular work within the hours of 12am and 6am.\n2. Presence of a chronic condition that significantly affects sleep.\n3. Severe psychiatric condition including major depressive disorder, panic disorder, substance use disorders, and alcohol abuse\u002Fdependence within the past 6 months, or a lifetime history of a psychotic disorder or bipolar I disorder, based on initial online\u002Fphone self-report diagnoses, and subsequently based on a structured psychiatric interview.\n4. Current use of medications affecting sleep such as antidepressants, antipsychotic medications, anticonvulsants, and steroids.\n5. Current use of sedating drugs used at bedtime.\n6. Consumption of \\> 14 alcohol drinks per week or \\> 6 drinks at a single sitting.\n7. Consumption of \\> 3 caffeine drinks per day.\n8. Prior diagnosis of a Central nervous system (CNS) disease, such as multiple sclerosis, stroke, Parkinson's disease, Alzheimer's disease, seizure disorder, delirium or dementia, a loss of consciousness \\> 24 hours, or traumatic brain injury as identified by the Cumulative Illness Rating Scale for Geriatrics (CIRS). Participants who are diagnosed with Alzheimer's disease based on neuropsychological testing will be excluded.\n9. Sleep efficiency \\> 90% and wake time after sleep onset \\\u003C 20 minutes consistent with the rationale of the inclusion criteria described above.\n10. Apnea\u002Fhypopnea index greater than 15 as determined by one night of Apnea Link Plus screening.\n11. Metal in the body. Rationale: Due to the nature of magnetic resonance imaging (MRI), participants cannot have any metal implants in their bodies, cannot have worked in a metal shop or been exposed to metal fragments during combat. Metal dental work (e.g. fillings crowns) may be allowed if compatible with the fMRI scanner.\n12. Claustrophobia. Rationale: Could prevent the participant from completing the MRI scans.\n13. Severe obesity. BMI \\> 40. Rationale: Could prevent the participant from completing the MRI scan.\n14. Near-miss or prior automobile accident \"due to sleepiness\" within the past 12 months. Rationale: reduces the risk of sleepiness-related accidents.\n15. Employed as a commercial driver during the study (for example, bus drivers, train engineers, airplane pilots). Rationale: reduces the risk of sleepiness-related accidents.\n16. A score below 23 on the Telephone Interview for Cognitive Status. Rationale: This cut-off has been demonstrated to differentiate well between individuals with mild cognitive impairment from individuals with dementia who would have decision making impairments (Seo et al. 2011, Archives of Gerontology and Geriatrics). This ensures that decision making abilities are intact.\n17. An Epworth sleepiness score greater than 10. Rationale: ensures that sleepiness is not excessive before starting the intervention that could further increase sleepiness. (Mazzotti, Diego R., et al. \"Is the Epworth Sleepiness Scale sufficient to identify the excessively sleepy subtype of OSA?.\" Chest 161.2 (2022): 557-561; Aurora, R. Nisha, et al. \"Correlating subjective and objective sleepiness: revisiting the association using survival analysis.\" Sleep 34.12 (2011): 1707-1714.)",true,"65 Years",{"count":64,"type":21},116,[66],"EARLY_PHASE1","Dementia caused by Alzheimer's disease affects approximately 5.6 million adults over age 65, with costs expected to rise from $307 billion to $1.5 trillion over the next 30 years. Behavioral interventions have shown promise for mitigating neurodegeneration and cognitive impairments. Sleep is a modifiable health behavior that is critical for cognition and deteriorates with advancing age and Alzheimer's disease. Thus, it is a priority to examine whether improving sleep modifies Alzheimer's disease pathophysiology and cognitive function. Extant research suggests that deeper, more consolidated sleep is positively associated with memory and executive functions and networks that underlie these processes. Preliminary studies confirm that time-in-bed restriction interventions increase sleep efficiency and non-rapid eye movement slow-wave activity (SWA) and suggest that increases in SWA are associated with improved cognitive function. SWA reflects synaptic downscaling predominantly among prefrontal connections. Downscaling of prefrontal connections with the hippocampus during sleep may help to preserve the long-range connections that support memory and cognitive function. In pre-clinical Alzheimer's disease, hyperactivation of the hippocampus is thought to be excitotoxic and is shown to leave neurons vulnerable to further amyloid deposition. Synaptic downscaling through SWA may mitigate the progression of Alzheimer's disease through these pathways. The proposed study will behaviorally increase sleep depth (SWA) through four weeks of time-in-bed restriction in older adults characterized on amyloid deposition and multiple factors associated with Alzheimer's disease risk. This study will examine whether behaviorally enhanced SWA reduces hippocampal hyperactivation, leading to improved task-related prefrontal-hippocampal connectivity, plasma amyloid levels, and cognitive function. This research addresses whether a simple, feasible, and scalable behavioral sleep intervention improves functional neuroimaging indices of excitotoxicity, Alzheimer's pathophysiology, and cognitive performance.",[69,32,70,71,30],"Alzheimer Disease, Late Onset","Sleep","Cognitive Change","2025-12-17",{"date":74,"type":44},"2025-12-19",{"date":76,"type":44},"2022-01-03",{"date":78,"type":21},"2026-05-31",{"name":80,"class":81},"University of Pittsburgh","OTHER",1,{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":61,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":113},"100610813","18fft8-pet-imaging-in-immunoglobulin-light-chain-amyloidosis-100610813","NCT07232459","[18F]FT8 PET Imaging in Immunoglobulin Light Chain Amyloidosis","Clinical Study of [18F]FT8 PET\u002FCT in Evaluating Amyloidosis","1. Subject Recruitment Participants will be recruited from outpatients and\u002For inpatient populations of the Hematology Department at Tianjin Medical University General Hospital. The principal investigator and collaborating hematologists will ensure consistent application of diagnosis and enrollment criteria based on standardized guidelines. The planned enrollment includes 20 patients with systemic amyloidosis (including cardiac involvement) and 5 healthy volunteers.\n2. Amyloidosis Patients:\n\n2.1 Inclusion Criteria:\n\nSubjects must meet all of the following criteria:\n\n1. Adult patients (age ≥ 18 years);\n2. Suspected, newly diagnosed, or previously diagnosed with cardiac amyloidosis, with supporting evidence from one or more of the following: cardiac MRI, contrast-enhanced CT, serum biomarkers (e.g., NT-proBNP, Troponin), or histopathological confirmation of amyloidosis.\n3. Scheduled to undergo a clinical Pan-Amyloid PET\u002FCT scan as part of standard care or clinical evaluation.\n4. Able to understand the study procedures and provide written informed consent. 2.2 Exclusion Criteria\n\nSubjects will be excluded based on any of the following:\n\n1. Confirmed non-cardiac amyloidosis or other non-amyloid cardiac pathologies that could confound image interpretation.\n2. Pregnancy or breastfeeding.\n3. Any medical, psychological, or social condition that, in the opinion of the investigator, would compromise the subject's ability to participate fully or complete the study follow-up.\n\n3\\. Healthy Volunteers: 3.1 Inclusion Criteria:\n\nSubjects must meet all of the following criteria:\n\n1. Adult subjects (age ≥ 18 years);\n2. No clinical evidence of active cardiac or systemic disease, as confirmed by medical history review, physical examination, and electrocardiogram (ECG).\n3. Able to understand the study procedures and provide written informed consent. 3.2 Exclusion Criteria:\n\nSubjects will be excluded based on any of the following:\n\n1. History or current diagnosis of any significant cardiac, hepatic, renal, or neurological disorder.\n2. Pregnancy or breastfeeding.\n3. Any condition that, in the opinion of the investigator, could pose an increased risk from the study procedure or interfere with the interpretation of study data.","18 Years",{"count":92,"type":21},25,"7 Days","OBSERVATIONAL","\\[18F\\]FT8, a derivative of 1-(4-pyridyl)-4-piperazinyl arene (\\[18F\\]TPZA), exhibits high affinity for AL amyloid in myocardial tissue sections and shows no significant binding to transthyretin amyloid. By comparing its diagnostic performance against established clinical methods, including echocardiography, contrast-enhanced MRI, and relevant laboratory tests, this study aims to establish \\[18F\\]FT8 as the basis for a robust PET protocol for the direct visualization and differential diagnosis of AL amyloidosis . The study preimarily evaluates the safety and diagnostic efficacy of \\[18F\\]FT8 PET imaging in human subjects.",[30,97,98,99],"Cardiac Amyloidosis","Amyloidosis","Healthy Subjects",[101,102,103],"PET\u002FCT","Cardiac amyloidosis","immunoglobulin light chain","2025-11-15",{"date":106,"type":44},"2025-11-18",{"date":108,"type":44},"2025-07-21",{"date":110,"type":21},"2028-12-20",{"name":112,"class":81},"Tianjin Medical University",2,{"id":115,"slug":116,"hasResults":11,"nctId":117,"briefTitle":118,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":61,"sex":16,"minAge":90,"maxAge":120,"enrollmentInfo":121,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":123,"conditions":124,"keywords":125,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":131,"completionDateStruct":133,"leadSponsor":135,"locationsCount":113},"100602980","pan-amyloid-petct-in-various-amyloid-related-disease-100602980","NCT07130565","Pan-Amyloid PET\u002FCT in Various Amyloid-Related Disease","Inclusion Criteria:\n\n\\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated cardiac amyloidosis (supporting evidence may include MRI, CT, serum markers and pathology report); (iii) patients who had scheduled Pan-Amyloid PET\u002FCT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n\\- (i) patients with non-CA lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.","80 Years",{"count":122,"type":21},500,"To evaluate the potential usefulness of 18F-92\u002FAV45\u002FTPZA\u002FFT8, 11C-PIB positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for the diagnosis of primary and metastatic lesions in various Pan-Amyloid-related disease patients.",[30,97,98],[101,126,127],"MRI","Pan-Amyloid","2025-08-12",{"date":130,"type":44},"2025-08-19",{"date":132,"type":44},"2023-11-01",{"date":134,"type":21},"2028-11-01",{"name":112,"class":81},{"id":137,"slug":138,"hasResults":11,"nctId":139,"briefTitle":140,"officialTitle":140,"acronym":4,"eligibilityCriteria":141,"healthyVolunteers":61,"sex":16,"minAge":90,"maxAge":120,"enrollmentInfo":142,"targetDuration":93,"studyType":94,"phases":4,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":40,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":155},"100571857","beta-amyloid-petct-in-various-a-related-disease-100571857","NCT06725706","Beta Amyloid PET\u002FCT in Various Aβ-Related Disease","Inclusion Criteria:\n\n\\- (i) adult patients (aged 18 years or order); (ii) patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); (iii) patients who had scheduled Aβ PET\u002FCT scan; (iv) patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.\n\nExclusion Criteria:\n\n\\- (i) patients with non-malignant lesions; (ii) patients with pregnancy; (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.",{"count":122,"type":21},"To evaluate the potential usefulness of 18F-92\u002FAV45, 11C-PIB positron emission tomography\u002Fcomputed tomography (PET\u002FCT) for the diagnosis of primary and metastatic lesions in various Tau-related disease patients.",[30,145,36],"Beta-Amyloid",[101,126,145],"2025-06-03",{"date":149,"type":44},"2025-06-04",{"date":151,"type":44},"2012-09-01",{"date":153,"type":21},"2027-12-01",{"name":112,"class":81},3]