Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2026-04-18 @ 12:27 AM
Study NCT ID:
NCT02928692
Status:
UNKNOWN
Last Update Posted:
2020-01-28
First Post:
2016-10-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D002292', 'term': 'Carcinoma, Renal Cell'}, {'id': 'C562573', 'term': 'cyclopia sequence'}, {'id': 'D000079690', 'term': 'Postoperative Cognitive Complications'}, {'id': 'D000071257', 'term': 'Emergence Delirium'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D007680', 'term': 'Kidney Neoplasms'}, {'id': 'D014571', 'term': 'Urologic Neoplasms'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003693', 'term': 'Delirium'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 750}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-25', 'studyFirstSubmitDate': '2016-10-05', 'studyFirstSubmitQcDate': '2016-10-06', 'lastUpdatePostDateStruct': {'date': '2020-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-10-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'POCD incidence 7 days (or before leaving hospital) after surgery', 'timeFrame': '7 days (or before leaving hospital)'}, {'measure': 'POD incidence', 'timeFrame': '1 to 5 days after surgery'}], 'secondaryOutcomes': [{'measure': 'POCD incidence 2 months after surgery', 'timeFrame': '2 months after surgery'}]}, 'conditionsModule': {'keywords': ['Minocycline', 'Postoperative cognitive dysfunction', 'Postoperative delirium'], 'conditions': ['Prostate Cancer', 'Carcinoma of the Rectum', 'Colon Cancer', 'Renal Carcinoma']}, 'referencesModule': {'references': [{'pmid': '23153950', 'type': 'BACKGROUND', 'citation': 'Large MC, Reichard C, Williams JT, Chang C, Prasad S, Leung Y, DuBeau C, Bales GT, Steinberg GD. Incidence, risk factors, and complications of postoperative delirium in elderly patients undergoing radical cystectomy. Urology. 2013 Jan;81(1):123-8. doi: 10.1016/j.urology.2012.07.086. Epub 2012 Nov 13.'}, {'pmid': '25017770', 'type': 'BACKGROUND', 'citation': 'Pol RA, van Leeuwen BL, Izaks GJ, Reijnen MM, Visser L, Tielliu IF, Zeebregts CJ. C-reactive protein predicts postoperative delirium following vascular surgery. Ann Vasc Surg. 2014 Nov;28(8):1923-30. doi: 10.1016/j.avsg.2014.07.004. Epub 2014 Jul 10.'}, {'pmid': '24384981', 'type': 'BACKGROUND', 'citation': 'Nadelson MR, Sanders RD, Avidan MS. Perioperative cognitive trajectory in adults. Br J Anaesth. 2014 Mar;112(3):440-51. doi: 10.1093/bja/aet420. Epub 2014 Jan 2.'}, {'pmid': '24093540', 'type': 'BACKGROUND', 'citation': 'Westhoff D, Witlox J, Koenderman L, Kalisvaart KJ, de Jonghe JF, van Stijn MF, Houdijk AP, Hoogland IC, Maclullich AM, van Westerloo DJ, van de Beek D, Eikelenboom P, van Gool WA. Preoperative cerebrospinal fluid cytokine levels and the risk of postoperative delirium in elderly hip fracture patients. J Neuroinflammation. 2013 Oct 7;10:122. doi: 10.1186/1742-2094-10-122.'}, {'pmid': '23040284', 'type': 'BACKGROUND', 'citation': 'Shim JJ, Leung JM. An update on delirium in the postoperative setting: prevention, diagnosis and management. Best Pract Res Clin Anaesthesiol. 2012 Sep;26(3):327-43. doi: 10.1016/j.bpa.2012.08.003.'}, {'pmid': '25516034', 'type': 'BACKGROUND', 'citation': 'van Meenen LC, van Meenen DM, de Rooij SE, ter Riet G. Risk prediction models for postoperative delirium: a systematic review and meta-analysis. J Am Geriatr Soc. 2014 Dec;62(12):2383-90. doi: 10.1111/jgs.13138.'}, {'pmid': '25535170', 'type': 'BACKGROUND', 'citation': 'American Geriatrics Society Expert Panel on Postoperative Delirium in Older Adults. Postoperative delirium in older adults: best practice statement from the American Geriatrics Society. J Am Coll Surg. 2015 Feb;220(2):136-48.e1. doi: 10.1016/j.jamcollsurg.2014.10.019. Epub 2014 Nov 14. No abstract available.'}, {'pmid': '24890941', 'type': 'BACKGROUND', 'citation': 'Bellelli G, Mazzola P, Morandi A, Bruni A, Carnevali L, Corsi M, Zatti G, Zambon A, Corrao G, Olofsson B, Gustafson Y, Annoni G. Duration of postoperative delirium is an independent predictor of 6-month mortality in older adults after hip fracture. J Am Geriatr Soc. 2014 Jul;62(7):1335-40. doi: 10.1111/jgs.12885. Epub 2014 Jun 2.'}, {'pmid': '19825488', 'type': 'BACKGROUND', 'citation': 'Ramaiah R, Lam AM. Postoperative cognitive dysfunction in the elderly. Anesthesiol Clin. 2009 Sep;27(3):485-96, table of contents. doi: 10.1016/j.anclin.2009.07.011.'}, {'pmid': '19444566', 'type': 'BACKGROUND', 'citation': 'Sauer AM, Kalkman C, van Dijk D. Postoperative cognitive decline. J Anesth. 2009;23(2):256-9. doi: 10.1007/s00540-009-0744-5. Epub 2009 May 15.'}, {'pmid': '9525362', 'type': 'BACKGROUND', 'citation': 'Moller JT, Cluitmans P, Rasmussen LS, Houx P, Rasmussen H, Canet J, Rabbitt P, Jolles J, Larsen K, Hanning CD, Langeron O, Johnson T, Lauven PM, Kristensen PA, Biedler A, van Beem H, Fraidakis O, Silverstein JH, Beneken JE, Gravenstein JS. Long-term postoperative cognitive dysfunction in the elderly ISPOCD1 study. ISPOCD investigators. International Study of Post-Operative Cognitive Dysfunction. Lancet. 1998 Mar 21;351(9106):857-61. doi: 10.1016/s0140-6736(97)07382-0.'}, {'pmid': '18156878', 'type': 'BACKGROUND', 'citation': 'Monk TG, Weldon BC, Garvan CW, Dede DE, van der Aa MT, Heilman KM, Gravenstein JS. Predictors of cognitive dysfunction after major noncardiac surgery. Anesthesiology. 2008 Jan;108(1):18-30. doi: 10.1097/01.anes.0000296071.19434.1e.'}, {'pmid': '19225398', 'type': 'BACKGROUND', 'citation': 'Steinmetz J, Christensen KB, Lund T, Lohse N, Rasmussen LS; ISPOCD Group. Long-term consequences of postoperative cognitive dysfunction. Anesthesiology. 2009 Mar;110(3):548-55. doi: 10.1097/ALN.0b013e318195b569.'}, {'pmid': '23558082', 'type': 'BACKGROUND', 'citation': 'Vacas S, Degos V, Feng X, Maze M. The neuroinflammatory response of postoperative cognitive decline. Br Med Bull. 2013;106(1):161-78. doi: 10.1093/bmb/ldt006. Epub 2013 Apr 4.'}, {'pmid': '17325501', 'type': 'BACKGROUND', 'citation': 'Wan Y, Xu J, Ma D, Zeng Y, Cibelli M, Maze M. Postoperative impairment of cognitive function in rats: a possible role for cytokine-mediated inflammation in the hippocampus. Anesthesiology. 2007 Mar;106(3):436-43. doi: 10.1097/00000542-200703000-00007.'}, {'pmid': '21575676', 'type': 'BACKGROUND', 'citation': 'Fidalgo AR, Cibelli M, White JP, Nagy I, Maze M, Ma D. Systemic inflammation enhances surgery-induced cognitive dysfunction in mice. Neurosci Lett. 2011 Jul 1;498(1):63-6. doi: 10.1016/j.neulet.2011.04.063. Epub 2011 May 6.'}, {'pmid': '20818791', 'type': 'BACKGROUND', 'citation': 'Cibelli M, Fidalgo AR, Terrando N, Ma D, Monaco C, Feldmann M, Takata M, Lever IJ, Nanchahal J, Fanselow MS, Maze M. Role of interleukin-1beta in postoperative cognitive dysfunction. Ann Neurol. 2010 Sep;68(3):360-8. doi: 10.1002/ana.22082.'}, {'pmid': '22190370', 'type': 'BACKGROUND', 'citation': 'Terrando N, Eriksson LI, Ryu JK, Yang T, Monaco C, Feldmann M, Jonsson Fagerlund M, Charo IF, Akassoglou K, Maze M. Resolving postoperative neuroinflammation and cognitive decline. Ann Neurol. 2011 Dec;70(6):986-995. doi: 10.1002/ana.22664.'}, {'pmid': '24162463', 'type': 'BACKGROUND', 'citation': 'Vacas S, Degos V, Tracey KJ, Maze M. High-mobility group box 1 protein initiates postoperative cognitive decline by engaging bone marrow-derived macrophages. Anesthesiology. 2014 May;120(5):1160-7. doi: 10.1097/ALN.0000000000000045.'}, {'pmid': '20711073', 'type': 'BACKGROUND', 'citation': 'Wan Y, Xu J, Meng F, Bao Y, Ge Y, Lobo N, Vizcaychipi MP, Zhang D, Gentleman SM, Maze M, Ma D. Cognitive decline following major surgery is associated with gliosis, beta-amyloid accumulation, and tau phosphorylation in old mice. Crit Care Med. 2010 Nov;38(11):2190-8. doi: 10.1097/CCM.0b013e3181f17bcb.'}, {'pmid': '23296426', 'type': 'BACKGROUND', 'citation': 'Su X, Feng X, Terrando N, Yan Y, Chawla A, Koch LG, Britton SL, Matthay MA, Maze M. Dysfunction of inflammation-resolving pathways is associated with exaggerated postoperative cognitive decline in a rat model of the metabolic syndrome. Mol Med. 2013 Feb 8;18(1):1481-90. doi: 10.2119/molmed.2012.00351.'}]}, 'descriptionModule': {'briefSummary': "Postoperative cognitive dysfunction (POCD) and postoperative delirium occurs mainly in aged patients. POCD and POD may increase the mortality and morbidity. However, the mechanism of POCD is not clear yet and no effective therapy method was proved. According to previous study, the neuroinflammation is the main reason both for POCD and POD. Minocycline is a tetracycline derivative. Due to it's lipophilic structure, it is easy to pass through blood brain barrier and attenuate neuroinflammation. It's neuroprotective effects has been proven in many experimental animal models such as Alzheimer's disease, Huntington's disease and Parkinson's syndrome. In present study, the investigators hypothesized that minocycline would attenuate the incidence of POCD and POD in the aged patients."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'For the placebo and minocycline group;\n\nInclusion Criteria:\n\n1. Elder than 65 years old\n2. Speak Chinese Mandarin\n3. Those who will undergo major general surgery like colorectal cancer excision, major urinary surgery like radical prostatectomy and radical nephrectomy\n4. Signed the inform consent\n5. American Society of Anesthesiologists classification I to III\n\nExclusion Criteria:\n\n1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;\n2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;\n3. Severe audition or vision disorder;\n4. Unwillingness to comply with the protocol or procedures.\n5. Cannot communicated with Chinese Mandarin\n6. With severe skin disease\n7. Serious heart or liver or renal insufficiency patients\n8. Had surgery in the past 30 days\n9. Allergy to tetracycline or minocycline\n\nFor the health volunteers;\n\nInclusion Criteria:\n\n1. Elder than 65 years old\n2. Speak Chinese Mandarin\n3. Signed the inform consent\n4. No major disease health people\n\nExclusion Criteria:\n\n1. Existing cerebral disease, or have a history of neurological and psychiatric diseases including Alzheimer Disease, stroke, epilepsy and psychosis;\n2. Existing cognitive impairment as evidenced by Mini-Mental State Examination scores below 24;\n3. Severe audition or vision disorder;\n4. Unwillingness to comply with the protocol or procedures.\n5. Cannot communicated with Chinese Mandarin\n6. Drug abuse, alcoholism\n7. Serious heart or liver or renal insufficiency patients\n8. Had surgery in the past 30 days\n9. Plan to undergo surgery in the following 3 months.'}, 'identificationModule': {'nctId': 'NCT02928692', 'acronym': 'MAPOCD', 'briefTitle': 'Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium', 'organization': {'class': 'OTHER', 'fullName': 'RenJi Hospital'}, 'officialTitle': 'Minocycline Attenuate Postoperative Cognitive Dysfunction and Delirium: A Multicenter, Randomized, Double-Blind Clinical Trail', 'orgStudyIdInfo': {'id': '20158202'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administered before surgery', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Minocycline', 'description': 'Minocycline was administrated before surgery', 'interventionNames': ['Drug: Minocycline']}, {'type': 'NO_INTERVENTION', 'label': 'Volunteers', 'description': 'Health people for calculate the incidence of POCD'}], 'interventions': [{'name': 'Minocycline', 'type': 'DRUG', 'armGroupLabels': ['Minocycline']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200127', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Diansan Su, Dr.', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '18616514088'}, {'name': 'Hui Li, M.S.', 'role': 'CONTACT', 'email': '56428923@qq.com', 'phone': '15216711923'}, {'name': 'Diansan Su, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Hui Li, M.S.', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Scales', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hongwei Duan', 'role': 'CONTACT', 'phone': '189-1879-0035'}], 'facility': 'Shanghai Pudong Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shifen Zhang', 'role': 'CONTACT', 'phone': '13916517543'}], 'facility': 'Shanghai Pudong New Area Dongming Community Health Care Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Lizhi Li, M.D.', 'role': 'CONTACT', 'email': 'Fmlilizhi@sina.com.cn', 'phone': '139-1768-2738'}], 'facility': "Shanghai Pudong New Area people's Hopsital", 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shukun Fu, M.D.', 'role': 'CONTACT', 'email': 'shukunfu@163.com', 'phone': '13816343916'}], 'facility': 'Shanghai Tenth Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Diansan Su, Doctor', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '18616514088'}, {'name': 'Hui Li, Master Degree Candidate', 'role': 'CONTACT', 'email': '56428923@qq.com', 'phone': '15216711923'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RenJi Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': "Shanghai 10th People's Hospital", 'class': 'OTHER'}, {'name': "Pudong New Area People's Hospital", 'class': 'UNKNOWN'}, {'name': 'Shanghai Pudong Hospital', 'class': 'OTHER'}, {'name': 'Shanghai Pudong New Aera Dongming Community Health Care Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'diansan su', 'investigatorAffiliation': 'RenJi Hospital'}}}}