[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556114":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":47,"responsibleParty":66,"collaborators":33,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":75,"eligibilityCriteria":76,"healthyVolunteers":71,"sex":77,"minAge":78,"maxAge":33,"enrollmentInfo":79,"targetDuration":33,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":50,"whyStopped":33,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"Distribuidora Biolife SA de CV","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"NANO-PSO","EXPERIMENTAL","640 mg of NANO-PSO (pomegranate seed oil)",[13],"Dietary Supplement: NANO-PSO (pomegranate seed oil)",{"label":15,"type":16,"description":17,"interventionNames":18},"Mineral oil","PLACEBO_COMPARATOR","640 mg of mineral oil",[19],"Dietary Supplement: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","NANO-PSO (pomegranate seed oil)","NANO-PSO administered orally, 2 capsules, equivalent to 640 mg of pomegranate seed oil, every 24 hours in the morning with food.",[9],[27,28],"Granagard","Omega 5",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Placebo administered orally, 2 capsules, equivalent to 640 mg of mineral oil, every 24 hours in the morning with food.",[15],null,[35],{"name":36,"affiliation":37,"role":38},"Alejandro Padilla Isassi, Geriatrician and researcher","Distribuidora Biolife S.A. de C.V.","PRINCIPAL_INVESTIGATOR",[40,44],{"name":36,"role":41,"phone":42,"phoneExt":33,"email":43},"CONTACT","+525589510727","alejandropadillaisassi@gmail.com",{"name":45,"role":41,"phone":42,"phoneExt":33,"email":46},"Abraham Samra Saad, Geriatrician and researcher","abrahamsamra@gmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Hospital Español. Av Ejercito Nacional 613, Miguel Hidalgo, CDMX, 11520","RECRUITING","Miguel Hidalgo","Mexico City","11520","Mexico","MX",{"type":57,"coordinates":58},"Point",[59,60],-99.20024,19.43411,{"lat":60,"lon":59},[63],{"name":64,"role":41,"phone":65,"phoneExt":33,"email":43},"Alejandro Padilla Isassi, Geriatrician","5625592234",{"type":38,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Alejandro Padilla Isassi","Principal researcher of the geriatrics area","100556114","phase-2-impact-of-nano-pso-on-cognition-in-older-adults-with-mild-to-moderate-cognitive-impairment-100556114",false,"NCT06520878","Impact of NANO-PSO on Cognition in Older Adults with Mild to Moderate Cognitive Impairment","Impact of NANO-PSO (omega 5) Supplementation on Cognitive Abilities of Older Adults with Mild to Moderate Non-vascular Cognitive Impairment","COGMEG5","Inclusion Criteria:\n\n* Patients attended at the Hospital Español.\n* Patients of any gender who are 60 years or older.\n* Patients presenting with mild to moderate cognitive impairment.\n* Meet the diagnostic criteria for \\"probable dementia\\" of the National Institute on Aging and the Alzheimer's Association (NIA-AA) (2011).\n* Meet the criteria for the typical variant of Alzheimer's disease, specifically a specific clinical phenotype.\n* Progressive and gradual change in memory functions reported by the patient or the informant for at least 6 months.\n* Objective evidence of a hippocampal-type amnesic syndrome, based on significant impairment in the performance of episodic memory tests with established specificity for AD.\n* Subjects are primary and secondary school graduates and have the ability to complete cognitive capacity tests and other specified tests in the program.\n* Total score on the Hachinski Ischemic Scale (HIS) ≤ 4.\n* Patients who sign the informed consent.\n\nExclusion Criteria:\n\n* Patients with known allergy to any component of the NANO-PSO capsule (e.g., fish).\n* Patients with short bowel syndrome, bariatric surgery, or gluten reaction that may affect intestinal absorption.\n* Patients in palliative care with a life expectancy of less than 6 months according to the NECPAL scale.\n* Patients with terminality criteria established in the comprehensive palliative care management guide of Mexico.","ALL","60 Years",{"count":80,"type":81},60,"ESTIMATED","INTERVENTIONAL",[84],"PHASE2","The objective of this randomized, triple-blind, placebo-controlled clinical trial is to compare NANO-PSO therapy against placebo in improving cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment. The primary questions it aims to answer are:\n\n• Does NANO-PSO therapy improve cognitive abilities in older adults with mild to moderate non-vascular cognitive impairment over six months of treatment compared to placebo?\n\nThe researchers will compare NANO-PSO therapy against placebo to see if it benefits the cognitive abilities of geriatric patients.\n\nParticipants will be required to:\n\n* Consume two capsules of NANO-PSO or placebo daily in the morning for six months.\n* Be evaluated monthly by phone to identify potential risks and ensure adherence to the treatment.\n* Be evaluated in person at 90 and 180 days of treatment.\n* The patient or primary caregiver must maintain a log to confirm daily dose consumption and will have a direct communication line with the attending physicians in case of questions about ingestion or possible adverse reactions.\n* At the end of the final patient evaluation, a quality questionnaire will be administered.",[87],"Cognition",[9,28,89,90,91],"Supplementation","Cognitive impairment","Antioxidants","2025-02-03",{"date":94,"type":95},"2025-02-06","ACTUAL",{"date":97,"type":81},"2025-02-12",{"date":99,"type":81},"2025-12-01",{"name":5,"class":6},1]