[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammation-brain\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammation-brain":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,53],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":41,"whyStopped":4,"lastUpdateSubmitDate":42,"lastUpdatePostDateStruct":43,"startDateStruct":46,"completionDateStruct":48,"leadSponsor":50,"locationsCount":4},"100529688","phase-2-mclena-2-a-phase-ii-clinical-trial-for-the-assessment-of-lenalidomide-in-patients-with-mild-cognitive-impairment-100529688",false,"NCT06177028","MCLENA-2: A Phase II Clinical Trial for the Assessment of Lenalidomide in Patients With Mild Cognitive Impairment","MCLENA-2: A Phase II Clinical Trial for the Assessment of Biomarker Trajectory in Patients With Mild Cognitive Impairment Due to Alzheimer's Disease Treated With Lenalidomide (Amendment to IND # 142121)","In order to be eligible for this study, subjects must meet the following inclusion criteria:\n\nInclusion Criteria:\n\n1. Male or female outpatients.\n2. At least 50 years of age, but less than 90 (89 at time of screening)\n3. Females must be surgically sterile (bilateral tubal ligation, oophorectomy, or hysterectomy) or postmenopausal for 2 years (no women at risk of pregnancy will be accepted in this study).\n4. Must have been diagnosed with amnestic MCI based on the most recent NIA-AA criteria (Albert et al., 2011), i.e. at both the screening and baseline visits (visits 1 and 2) have a documented Mini Mental State Exam (MMSE) score between 22-28.\n5. CT or MRI scan of the brain obtained during the course of the dementia must be consistent with the diagnosis and show no evidence of significant focal lesions or of pathology which could contribute to dementia. If neither a CT nor an MRI scan is available from the past 12 months, a CT scan fulfilling the requirements must be obtained before randomization.\n6. Vision and hearing must be sufficient to comply with study procedures.\n7. Be able to take oral medications.\n8. Hachinski ischemic score must be ≤ 4.\n9. Geriatric depression scale must be ≤ 10.\n10. Can be on stable doses of a cholinesterase inhibitor and\u002For memantine as long as it is stable for at least 90 days before screening and is expected to remain on a stable dose for the remainder of the study period; or have demonstrated intolerance to or lack of efficacy from these medications.\n11. Must have a collateral informant\u002Fstudy partner who has significant direct contact with the patient at least 10 hours per week and who is willing to accompany the patient to specified clinic visits, supervise administration of all study medication, and be available for telephone visits\u002Finterviews.\n12. If the patient has a legally authorized representative (LAR), the LAR must review and sign the informed consent form. If the patient does not have an LAR, the patient must appear able to provide informed consent and must review and sign the informed consent form. In addition, the patient's informant\u002Fstudy partner (as defined above) must sign an informed consent form. If the LAR and the patient's informant \u002Fstudy partner is the same individual, he\u002Fshe should sign under both designations.\n13. Must reside in the community.\n14. Patients with stable prostate cancer may be included at the discretion of the Medical Monitor.\n15. Positivity for amyloid brain scan: Amyloid PET positive at SUVr of 1.05\n\nExclusion Criteria:\n\nSubjects will be excluded if they have any of the condition listed below:\n\n1. Current evidence or history within the last 3 years of a neurological or psychiatric illness that could contribute to dementia, including (but not limited to) epilepsy, focal brain lesion, Parkinson's disease, seizure disorder, head injury with loss of consciousness\n2. DSM IV criteria for any major psychiatric disorder including psychosis, major depression and bipolar disorder.\n3. Unwilling or unable to undergo a Lumbar Puncture.\n4. Known history or self-reported alcohol or substance abuse.\n5. Living alone.\n6. Poorly controlled hypertension. 7 .History of myocardial infarction or signs or symptoms of unstable coronary artery disease within the last year (including revascularization procedure\u002Fangioplasty).\n\n8\\. Severe pulmonary disease (including chronic obstructive pulmonary disease) requiring more than 2 hospitalizations within the past year.\n\n9\\. Untreated sleep apnea. 10. Any thyroid disease (unless euthyroid on treatment for at least 6 months prior to screening).\n\n11\\. Active neoplastic disease (except for skin tumors other than melanoma) within five years.\n\n12\\. History of multiple myeloma. 13. Absolute neutropenia of \\\u003C750\u002Fmm3, or a history of neutropenia. 14. History of or current thromboembolism (including deep venous thrombosis). 15. Any clinically significant hepatic or renal disease (including presence of Hepatitis B or C antigen\u002Fantibody or an elevated transaminase levels of greater than two times the upper limit of normal (ULN) or creatinine greater than 1.5 x ULN).\n\n16\\. Clinically significant hematologic or coagulation disorder including any unexplained anemia or a platelet count less than 100,000\u002FμL at screening.\n\n17\\. Use of any investigational drug within 30 days or within five half-lives of the investigational agent, whichever is longer.\n\n18\\. Use any investigational medical device within two weeks before screening or after end of the present study.\n\n19\\. Females who are at risk of pregnancy or are of child bearing age. 20. Unwilling or unable to undergo MRI and PET imaging. 21. Cardiac pacemaker or defibrillator or other implanted device. 22. In the opinion of the investigator, participation would not be in the best interest of the subject",true,"ALL","50 Years","90 Years",{"count":21,"type":22},45,"ESTIMATED","INTERVENTIONAL",[25],"PHASE2","This is a randomized, double-blind, placebo-controlled, parallel group study. The use of placebo is appropriate to minimize bias related to treatment expectations of the subject, study partner, and site investigator, as well as to changes in the relationship between the subject and study partner that might occur with the initiation of treatment and expectation of improvement in motor symptoms or cognition. Changes in subject\u002Fstudy partner interactions can impact subject mood and might introduce biases that cannot be quantified. The double-blind use of placebo will also prevent bias in the clinical and scientific assessments.",[28,29,30,31,32],"Cognitive Impairment, Mild","Cognitive Dysfunction","Amyloid Plaque","Neurodegenerative Disease, Hereditary","Inflammation, Brain",[34,35,36,37,38,39,40],"Alzheimer's disease","CSF","Biomarkers","Brain Imaging","Brain Amyloid","Memory Loss","Immunomodulation","NOT_YET_RECRUITING","2025-05-14",{"date":44,"type":45},"2025-05-18","ACTUAL",{"date":47,"type":22},"2025-06-01",{"date":49,"type":22},"2027-01-02",{"name":51,"class":52},"St. Joseph's Hospital and Medical Center, Phoenix","OTHER",{"id":54,"slug":55,"hasResults":11,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":16,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":66,"studyType":67,"phases":4,"briefSummary":68,"conditions":69,"keywords":4,"overallStatus":71,"whyStopped":4,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":81},"100581622","predictive-biomarkers-of-altered-neurological-trajectories-consequent-to-prenatal-inflammatory-insults-100581622","NCT06852703","Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL InflammatorY Insults","Predictive BioMArkers of AlTERed NeurologicAL Trajectories Consequent to PrenataL","MATERNALLY","Inclusion Criteria:\n\nAge between 18 and 40 years. BMI between 18 kg\u002Fm2 and 25 kg\u002Fm2. Negative remote medical history for chronic conditions (rheumatological, immunological, endocrinological).\n\nNegative obstetric history for significant pathologies (pre-eclampsia, gestational diabetes, preterm birth).\n\nReassuring combined test\n\nExclusion Criteria:\n\n* Pre-gestational diabetes\n* Multiple pregnancy\n* Threatened preterm labor and\u002For premature rupture of membranes\n* Pre-eclampsia\n* Intrauterine growth restriction (IUGR)\n* Fetal macrosomia (biometrics \\>90th percentile)\n* Chromosomal syndromes, genetic conditions, or multiple fetal malformations or major fetal malformations\n* Withdrawal of informed consent\n* Smoking patients are not excluded from the study, nor are patients who develop gestational diabetes during pregnancy.","FEMALE","18 Years","40 Years",{"count":65,"type":22},300,"3 Years","OBSERVATIONAL","Inflammation during pregnancy represents an important risk factor for the development of neuropsychiatric disorders in the offspring. Despite clear epidemiological data supporting this association, translational studies aimed at identifying early predictive biomarkers and possible interventional strategies for this pathological condition are still missing. The MATERNALLY proposal aims to assess in a large patient cohort a novel multiparametric approach for the identification of predictive postnatal behavioral and circulating biomarkers. In parallel, a controlled mouse model for maternal immune activation will be exploited to understand the basic molecular mechanism that links inflammation with aberrant neural circuit formation and to unveil possible therapeutic targets. The integration of the two approaches will allow identifying early predictive biomarkers and proof of principle interventional strategies for this condition of high practical relevance to the neonatologist community",[36,70,32],"Neurodevelopmental Disorders","RECRUITING","2025-02-24",{"date":74,"type":45},"2025-02-28",{"date":76,"type":45},"2021-09-01",{"date":78,"type":22},"2025-08-31",{"name":80,"class":52},"Istituto Clinico Humanitas",1]