[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cognitive-decline-mild\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cognitive-decline-mild":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100543963","phase-2-fasudil-trial-for-treatment-of-early-alzheimers-disease-fead-100543963",false,"NCT06362707","Fasudil Trial for Treatment of Early Alzheimer's Disease (FEAD)","A Placebo Controlled Randomized Double-blind Parallel Group 12-month Trial of Fasudil for the Treatment of Early Alzheimer's Disease (FEAD)","FEAD","Inclusion Criteria:\n\n* Early AD, eg Stage 3 MCI or Stage 4 (mild AD dementia), as recently defined by the FDA (2018; Figure 2)\n* A significant change on a validated AD amyloid or tau biomarker (as determined either by visual reading of amyloid PET scans using any of the approved ligands, or CSF Aβ 1-42 levels or blood p-tau 217 cut-offs as determined by the clinical research laboratory)\n* A CDR Global rating of 0.5 or 1.0 (Morris 1993) and have an MRI scan within the past two years that has no findings inconsistent with AD\n* Capacity to give informed consent based on the clinical judgement of an experienced clinician\n* The participant needs to have a reliable study partner with regular contact (a combination of face-to-face visits and telephone contact is acceptable) who has sufficient interaction with the participant to provide meaningful input into rating scales\n* Age from 50 years\n* Fluency in Norwegian and evidence of adequate premorbid intellectual functioning\n* Capable of participating in all scheduled evaluations and complete all required tests\n* Female participants must be of non-childbearing potential or have a negative serum pregnancy test within 14 days of baseline assessments and agree to the use of effective birth control throughout their participation in the study\n\nExclusion Criteria:\n\n* Significant cerebrovascular disease, as indicated by clinical history, neurological examination, or on MRI (including cortical infarction or deep white matter or periventricular white matter hyperintensities with a Fazekas scale score of 3 (Fazekas et al 1987).\n* A history of cerebrovascular bleeding or severe bleeding of the digestive tract, lungs, nose or skin\n* Severe renal impairment (GFR \\\u003C30) or serum creatinine or urea nitrogen values ≥3 times Upper normal limit (ULN) at screening or baseline\n* Moderate to severe hepatic impairment. Serum alanine transaminase (ALT) or aspartate transaminase levels ≥3 times ULN at screening or baseline\n* Currently poorly controlled diabetes as indicated by HbA1c values \\>9\n* White blood cell (WBC) values \\\u003C3.5 K\u002Fμl\n* History of paralytic ileus or current severe chronic constipation\n* Known allergy to fasudil or established systemic inflammatory disease or autoimmune disease.\n* Clinically significant hypotension defined by blood pressure values \\\u003C90\u002F60 mmHg, regardless of the individual's sitting or standing position and associated with relevant clinical symptoms (e.g., tachycardia, dizziness, syncope)\n* Current clinically significant depression or other mental disorder likely to affect cognition or interfere with study participation\n* Recent (within 3 months) relevant medication changes. Participants must have been on stable anti-dementia (cholinesterase inhibitors or memantine) or anti-depressive medications for at least three months before the study\n* Participants using sedating drugs, if unavoidable, will be excluded from the study. However, short-acting sleep medications can be used if taken as recommended and if the participant has maintained stability on them for a minimum of 3 months prior to the start of the study\n* Participation in other drug trials\n* Currently ongoing life-threatening disease, such as metastatic cancer, advanced cardiovascular disease, advanced respiratory disease, terminal kidney disease, or advanced stages of infectious diseases\n* Any current or past neurological disease unrelated to Alzheimer's disease with cognitive sequelae\n* A Corrected QT (QTc) interval ≥ 460 milliseconds for males or ≥ 470 milliseconds for females will be considered abnormal during the ECG assessments","ALL","50 Years","100 Years",{"count":21,"type":22},200,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","The goal of this placebo-controlled double-blind Phase 2 clinical trial is to test in people with early Alzheimer's Disease.\n\nThe main questions it aims to answer are:\n\n* Does treatment with fasudil, a ROCK-inhibitor, lead to significant improvement in working memory (based on computer-based working memory composite scores) compared to placebo in individuals with early Alzheimer's disease (AD) over 12 months?\n* What is the effect of fasudil treatment for 12 months on other cognitive functions, brain metabolism measured by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET), and other relevant clinical functions and biomarkers in individuals with early Alzheimer's disease (AD)?\n* Treatment will be escalated to a maintenance dose of 120 mg total daily dose for up to 50 weeks, with regular clinic visits for efficacy and safety evaluations.\n* Assessments will include cognitive tests, FDG-PET scans, and biomarker analyses, with follow-up by the Data and Safety Monitoring Board for ongoing safety review.\n\nThe study will compare participants receiving fasudil with those receiving placebo to see if fasudil treatment leads to improvements in cognitive functions, brain metabolism measured by FDG-PET.",[28,29],"Cognitive Decline, Mild","Alzheimer Disease",[29,31,32],"Mild Cognitive Decline","Fasudil","RECRUITING","2026-04-28",{"date":36,"type":37},"2026-05-04","ACTUAL",{"date":39,"type":37},"2024-08-01",{"date":41,"type":22},"2028-01-01",{"name":43,"class":44},"Helse Stavanger HF","OTHER_GOV",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":60,"conditions":61,"keywords":62,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100554138","cognition-flavonoids-exercise-gut-microbiome-100554138","NCT06495190","Cognition, Flavonoids, Exercise, Gut Microbiome","Age-related Cognitive Changes: Effects of Combined Flavonoid Intake and Physical Exertion Mediated by the Gut Microbiome","Inclusion Criteria:\n\n* Score on the Montreal Cognitive Assessment (MoCA test) of 24.1-25.2 that indicates mild cognitive decline. The MoCA test score ranges from 0 to 30, with higher scores from 26 to 30 considered normal.\n* Healthy, non-smoking male or female participants 65 to 85 years of age.\n* Capable of engaging in a supervised 12-week exercise training program (brisk walking or stretching).\n* Physically inactive (defined as less than 150 min\u002Fweek moderate or less than 75 minutes vigorous aerobic and\u002For resistance exercise during the past 4 weeks).\n* Willingness to be randomized to one of four groups.\n* Willingness to provide blood, urine, and fecal samples (3 each),\n* Willingness to avoid blueberry intake during the 12-weeks study (other than what is provided through the study).\n* Willingness to maintain current diet and physical activity patterns during the study (other than what is prescribed as a part of the study), and make no formal attempts to lose or gain body weight.\n* Willingness to be a participant in this study only and not enter any other studies.\n\nExclusion Criteria:\n\n* Allergy to blueberries.\n* Diagnosis of Type I or Type 2 diabetes.\n* Chronic cardiovascular, metabolic, or renal condition that is uncontrolled (controlled defined as stable for 6 months or more).\n* History of signs or symptoms during rest or physical activity such as chest discomfort, unreasonable breathlessness, dizziness, fainting, or blackouts.\n* Use of any prescription or over-the-counter drug intended to support cognition or with known cognitive side effects.\n* Any other concurrent condition or use of medications or supplements which, in the opinion of the study clinician would preclude participation in this study.\n* Diagnosis of dementia.",true,"65 Years","85 Years",{"count":57,"type":22},240,[59],"NA","This NIH project will examine the effects of routine flavonoid-rich blueberry intake (12-weeks), combined with or in the absence of regular moderate exercise, on cognitive function in a clinical population of older participants identified as experiencing age-related cognitive changes. This project's hypothesis is that the combination of flavonoid-rich diet and routine physical activity may potentiate cognitive benefits and reduce cognitive decline in an aging population, via mechanisms mediated by the gut microbiome.",[28],[63,64,65,66],"aging","flavonoids","exercise","gut microbiome","2025-03-07",{"date":69,"type":37},"2025-03-12",{"date":71,"type":37},"2025-01-01",{"date":73,"type":22},"2028-12-31",{"name":75,"class":76},"Appalachian State University","OTHER",1]