[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606678":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":26,"locations":31,"responsibleParty":65,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":26,"enrollmentInfo":80,"targetDuration":26,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":90,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"University of Saskatchewan","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NeuroEPO + standard of care","EXPERIMENTAL","NeuroEPO + standard of care for Alzheimer's Disease",[13],"Drug: NeuroEPO",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo + standard of care","PLACEBO_COMPARATOR","Placebo + standard of care for Alzheimer's disease",[19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","NeuroEPO","0.5 mg of NeuroEPO will be administered intranasally three times a week for 52 weeks.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Placebo","250 µL of placebo will be administered to intranasally to each nostril three times a week for 52 weeks.",[15],[32],{"facility":5,"status":26,"city":33,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"Saskatoon","Saskatchewan","S7N5E5","Canada","CA",{"type":39,"coordinates":40},"Point",[41,42],-106.66892,52.13238,{"lat":42,"lon":41},[45,50,53,56,58,60,62,64],{"name":46,"role":47,"phone":48,"phoneExt":26,"email":49},"C. Ron Geyer, PhD","CONTACT","3069662040","clg595@mail.usask.ca",{"name":51,"role":47,"phone":26,"phoneExt":26,"email":52},"Wendy Bernhard, PhD","wlb302@mail.usask.ca",{"name":54,"role":55,"phone":26,"phoneExt":26,"email":26},"Andrew Kirk, MD","PRINCIPAL_INVESTIGATOR",{"name":46,"role":57,"phone":26,"phoneExt":26,"email":26},"SUB_INVESTIGATOR",{"name":59,"role":57,"phone":26,"phoneExt":26,"email":26},"Krista Lagimodiere, MD",{"name":61,"role":57,"phone":26,"phoneExt":26,"email":26},"Megan Surkan, MD",{"name":63,"role":57,"phone":26,"phoneExt":26,"email":26},"Kris Barreto, PhD",{"name":51,"role":57,"phone":26,"phoneExt":26,"email":26},{"type":55,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Andrew Kirk","Principal Investigator",[69],{"name":70,"class":6},"Center of Molecular Immunology, Cuba","100606678","phase-2-evaluation-of-the-safety-and-efficacy-of-neuroepo-in-subjects-with-mild-to-moderate-alzheimers-disease-100606678",false,"NCT07178678","Evaluation of the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease","A Phase II, Blinded, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of NeuroEPO in Subjects With Mild to Moderate Alzheimer's Disease Who Are Receiving Standard of Care Treatment","Inclusion Criteria:\n\n* Patients \\>= 50 years of age, to reflect the population that will be treated and to avoid younger populations who may be suffering dementia from a cause other than Alzheimer's Disease.\n* Patients with Global Deterioration Scale (GDS) between 3 to 5 points (inclusive).\n* Clinical Dementia Rating (CDR) - GS score 1-2 at screening.\n* Patients with permeable airways.\n* Patients (or caregiver, if the patient cannot) grant consent to participate in the study by signing the informed consent form.\n* Patient with caregiver is physically and mentally willing to collaborate with the investigation.\n* Mini-Mental State Examination (MMSE) score between 14 and 26 (inclusive) at screening\n\nExclusion Criteria:\n\n* Evident mental disability or other limitation that prevents the patient or caregiver from administering the study evaluations.\n* Patients with neurological symptoms or signs that suggest another cause of dementia.\n* Skull trauma or recent intracranial surgery.\n* Known clotting disorders.\n* Use of anticoagulants, a medication to prevent harmful blood clots (warfarin, heparin or NOAC).\n* Patients where coexistence of another disease or condition that may lead to significant disability (cancer, septic embolism, endocarditis, myeloproliferative disease, creatinine\\> 3 mg \u002F dl (265µmol \u002F L), hyperkalemia \\> 5.0 mmol \u002F L, chronic\u002Fsevere liver or kidney or heart disorders.\n* Patients with a history of hypersensitivity to rhEPO.\n* Patients with known allergy to any ingredients of the product.\n* Patients who present nasal irritation (sneezing) or a runny nose before starting treatment.\n* Patients who present asthma attack at the beginning of the treatment.\n* Patients receiving treatment with AChE-I or Memantine who are not stable for 12-weeks prior to screening.\n* Patients receiving treatment with psychoactive that can compromise the clinical trial results or neuropsychological tests.\n* Patients with a history of alcoholism and\u002For drug dependence.\n* Patients with chronic rhinosinusitis.\n* Have a history of abnormal nasal or sinus symptoms.\n* Have prior skull fracture or abnormality (nasal defect, deviated septum).\n* Have recent nasal trauma (fracture in the last 2 months).\n* Have any prior sinus or nose surgery (rhinoplasty).\n* Have known bleeding problem (low platelets-thrombocytopenia), recurrent nose bleeds (\\>3 year).\n* Have acute inflammation inside the nose.\n* Congenital cranial facial disorders.","ALL","50 Years",{"count":81,"type":82},90,"ESTIMATED","INTERVENTIONAL",[85],"PHASE2","The goal of this clinical trial is to test if NeuroEPO improves or maintains cognition in adults with mild to moderate Alzheimer's Disease using a cannula attached to a syringe for delivery. It will also learn the safety of NeuroEPO. The main questions it aims to answer are:\n\nDoes NeuroEPO lower or maintain a person's cognition who has been diagnosed with Alzheimer's Disease? What medical problems do participants have when taking NeuroEPO?\n\nResearchers will compare NeuroEPO to a placebo (a look-alike substance that contains no drug) to see if NeuroEPO works to treat Alzheimer's Disease.\n\nParticipants will:\n\nTake NeuroEPO or a placebo three times a week for one year Visit the clinic to determine eligibility, for cognitive testing and blood tests at the start and end of the trial and at 1, 2, 6 and 12 months for check ups and blood collection",[88,89],"Mild Alzheimer's Disease","Moderate Alzheimer's Disease",[91,23,92,93],"Alzheimer's Disease","EPO","ADAS-cog13","NOT_YET_RECRUITING","2025-09-10",{"date":97,"type":98},"2025-09-17","ACTUAL",{"date":100,"type":82},"2025-11",{"date":102,"type":82},"2030-12",{"name":5,"class":6},1]