Ignite Creation Date:
2025-12-24 @ 12:57 PM
Ignite Modification Date:
2025-12-27 @ 9:23 PM
Study NCT ID:
NCT04924361
Status:
UNKNOWN
Last Update Posted:
2022-09-13
First Post:
2021-05-18
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}, {'id': 'D000093902', 'term': 'Mixed Dementias'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D020961', 'term': 'Lewy Body Disease'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-09-10', 'studyFirstSubmitDate': '2021-05-18', 'studyFirstSubmitQcDate': '2021-06-06', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incorporating age stratified biomarkers into the diagnosis of dementia', 'timeFrame': 'Through study completion,an average of 5 years', 'description': 'Comparing the relationships between biomarkers and clinical presentations as well as neuroimaging. Incorporate biomarkers into the accurate and early diagnosis of dementia'}], 'secondaryOutcomes': [{'measure': 'Establishing dementia cohort including detailed clinical information, fluid samples and brain bank', 'timeFrame': 'Through study completion,an average of 5 years', 'description': 'Detailed clinical information including demographic data, clinical history, past history and physical examination are collected. Formatted neuropsychological battery is used in all patients, including screening tests (MMSE, MoCA-PUMCH, ADL, HAD) and domain specific evaluation (Memory, executive function, visual spatial, calculation, language). Samples including serum, CSF, urine, skin, saliva are stored. Every patient is followed up every 6 months. Autopsy brain tissue will be collected if patients died after informed consent.'}, {'measure': 'Exploring 5-10 kinds of age stratified biomarkers, including neuropsychology, neuroimaging, fluid biomarkers and genetic biomarkers', 'timeFrame': 'Through study completion,an average of 5 years', 'description': 'Find out age stratified biomarkers with high sensitivity and specificity, including neuropsychology, Multi-model neuroimaging, Multi-omics fluid biomarkers and genetic biomarkers'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Biomarkers', 'Diagnosis'], 'conditions': ['Dementia', 'Dementia, Vascular', 'Dementia Frontal', 'Dementia, Mixed', 'Dementia Alzheimers', 'Dementia With Lewy Bodies']}, 'referencesModule': {'references': [{'pmid': '24234358', 'type': 'BACKGROUND', 'citation': 'Kuruppu DK, Matthews BR. Young-onset dementia. Semin Neurol. 2013 Sep;33(4):365-85. doi: 10.1055/s-0033-1359320. Epub 2013 Nov 14.'}, {'pmid': '30707185', 'type': 'BACKGROUND', 'citation': 'Rabinovici GD. Late-onset Alzheimer Disease. Continuum (Minneap Minn). 2019 Feb;25(1):14-33. doi: 10.1212/CON.0000000000000700.'}, {'pmid': '23732531', 'type': 'BACKGROUND', 'citation': 'Yang Z, Slavin MJ, Sachdev PS. Dementia in the oldest old. Nat Rev Neurol. 2013 Jul;9(7):382-93. doi: 10.1038/nrneurol.2013.105. Epub 2013 Jun 4.'}, {'pmid': '29653606', 'type': 'BACKGROUND', 'citation': "Jack CR Jr, Bennett DA, Blennow K, Carrillo MC, Dunn B, Haeberlein SB, Holtzman DM, Jagust W, Jessen F, Karlawish J, Liu E, Molinuevo JL, Montine T, Phelps C, Rankin KP, Rowe CC, Scheltens P, Siemers E, Snyder HM, Sperling R; Contributors. NIA-AA Research Framework: Toward a biological definition of Alzheimer's disease. Alzheimers Dement. 2018 Apr;14(4):535-562. doi: 10.1016/j.jalz.2018.02.018."}]}, 'descriptionModule': {'briefSummary': 'Biomarkers are important for early and precise diagnosis of dementia. However, the causes of dementia in different age are different. We designed an age stratified dementia cohort and tried to explore biomarkers of different groups of dementia, incorporating neuropsychology, multi-model neuroimaging, metabolics and proteomics based fluid biomarkers as well as genetic biomarkers. Autopsy after clinical follow up help to verify the biomarkers.', 'detailedDescription': 'Baseline data collection and cohort establishing: Detailed clinical information including demographic data, clinical history, past history and physical examination are collected. Formatted neuropsychological battery is used in all patients, including screening tests (MMSE, MoCA-PUMCH, ADL, HAD) and domain specific evaluation (Memory, executive function, visual spatial, calculation, language). Samples including serum, CSF, urine, skin, saliva are stored. Every patient is followed up every 6 months. Autopsy brain tissue will be collected if patients died.\n\nMulti-model neuroimaging evaluation: Structure and functional brain 3T-MRI; 7T-MRI； PET-CT including FDG, Aβ（18F-AV45）,tau（18F-THK5317, 18F-T807）; EEG\n\nMulti-omics biomarkers research:\n\nCSF AD biomarkers (Aβ40,42, ptau181, ttau, NfL, Neurogranin), comparison of different methods, including ELISA, Electrochemical, Mass Spectroscopy. The standardization of CSF biomarkers analysis in China.\n\nExploring new fluid biomarkers: CSF and Urine proteomics; CSF and serum glycomics and metabolomics. To explore new biomarkers in differentiation of different causes of dementia, age onset and prognosis of dementia.\n\nGenetic biomarkers evaluation: including pathogenic gene mutation panel examination and WES.\n\nData analysis and biomarkers evaluation: Dementia patients are stratified based on age onset, cause of dementia, cognition severity, effect of therapy, prognosis. Identify multi-omics biomarkers in different groups. Comparing the relationships between biomarkers and clinical presentations as well as neuroimaging. Autopsy based accurate diagnosis help further defining biomarkers.\n\nAcquiring stratified biomarkers with high sensitivity and specificity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'We included age stratified dementia (early onset, late onset, oldest old) , including AD, FTD,VaD, DLB and mixed dementia. Also we include cognitive normal controls.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neurodegenerative dementia diagnosis based on 2011 NIA-AA criteria of Dementia\n* Fixed care giver and can follow up regularly\n\nExclusion Criteria:\n\n* Not demented, including MCI\n* Systemic severe diseases and severe vision or hearing problem effecting follow up and neuropsychological evaluation\n* Without fixed care giver\n* Reject informed consent\n* Expected life shorter than 2 years'}, 'identificationModule': {'nctId': 'NCT04924361', 'briefTitle': 'Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort', 'organization': {'class': 'OTHER', 'fullName': 'Peking Union Medical College Hospital'}, 'officialTitle': 'Exploring Biomarkers in Age Stratified PUMCH Dementia Cohort', 'orgStudyIdInfo': {'id': 'PUMCH Dementia Cohort Research'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early onset dementia', 'description': 'Dementia patients with onset age lower than 65y/o'}, {'label': 'Late onset dementia', 'description': 'Dementia patients with onset age between 65y/o and 85y/o'}, {'label': 'Oldest old dementia', 'description': 'Dementia patients with onset age older than 85y/o'}, {'label': 'Cognitive normal control', 'description': 'cognitive normal control'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chenhui Mao, Doctor', 'role': 'CONTACT', 'email': 'maochenhui@pumch.cn'}, {'name': 'Jing Gao, Doctor', 'role': 'CONTACT', 'email': 'gj107@163.com'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Chenhui Mao, Doctor', 'role': 'CONTACT', 'email': 'maochenhui@pumch.cn', 'phone': '+86018611895308'}], 'overallOfficials': [{'name': 'Jing Gao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peking Union Medical College Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Department of Neurology', 'investigatorFullName': 'gaojing', 'investigatorAffiliation': 'Peking Union Medical College Hospital'}}}}