Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-01-02 @ 1:27 AM
Study NCT ID:
NCT03846232
Status:
COMPLETED
Last Update Posted:
2023-03-31
First Post:
2019-02-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2019-02-18', 'studyFirstSubmitQcDate': '2019-02-18', 'lastUpdatePostDateStruct': {'date': '2023-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detection of abnormal cerebral protein levels', 'timeFrame': 'at inclusion', 'description': 'Discriminant capacity to detect abnormal cerebral protein levels in 3 age-matched groups: cognitively normal subjects without (CN) and with abnormal biomarker levels (PreAD), and Alzheimer Disease patients (AD).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'The main goal of the T1rho/BBRC2017 study is to assess the capability of the MRI sequences T1rho + multicomponent T2 relaxation analysis of detecting abnormal cerebral protein deposition in AD patients in comparison with an age-matched cognitively healthy control group. Both the AD and control groups will had previously undergone amyloid PET imaging to confirm/discard cerebral proteinopathy in the context of other research studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participating subjects are (1) patients with AD with typical presentation for which an amyloid PET is already available or (2) age-matched cognitively healthy adults that, similarly, have available amyloid PET imaging information.\n\nSpecifically, a subsample of 40 cognitively healthy adult participants from the ALFA study \\[25\\] (http://clinicaltrials.gov/ct2/show/NCT01835717; Estudi 45-65 FPM/2012) will be selected to undergo the present study on the basis of their cerebral amyloidosis as assessed by PET in the context of the PET FLUTEMETAMOL-FDG/BBRC2015 study (20 negative and 20 positive). AD patients (n=20) will be recruited from collaborating institutions.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 60 years\n* Informed, written consent form\n* To fully satisfy the criteria for one of the two following 2 groups:\n\n 1. for the AD group:\n\n * Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers): Light to mild AD defined by Mini-Mental State Examination (MMSE) score between 15 and 27 (included).\n * Documented positive visual read (as per EMA-approved procedures for each respective tracer) of an amyloid PET scan, which in the opinion of the principal investigator is consistent with a diagnosis of AD in the last 24 months.\n * Lumbar puncture with core AD CSF biomarkers available in the last 24 months.\n 2. For the cognitively health group:\n\n * Normal cognition as defined by the ALFA study cognitive workup (Molinuevo et al. 2016).\n\nCONFIDENTIAL 17\n\n* \\[18F\\]-Flutemetamol PET scan performed in the context of the PET FLUTEMETAMOL-FDG/BBRC2015 study in the last 24 months.\n* Lumbar puncture with core AD CSF biomarkers preferably available in the last 24 months.\n\nExclusion Criteria:\n\n* Past or present history of major brain disorders other than MCI or AD.\n* Contraindication to MRI scanning or conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).\n* Participation in a clinical trial for a disease modifying drug for AD.\n* Hypoperfusion pattern not consistent with AD diagnosis, as assessed by ASL.'}, 'identificationModule': {'nctId': 'NCT03846232', 'acronym': 'T1rho', 'briefTitle': "Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging", 'organization': {'class': 'OTHER', 'fullName': 'Barcelonabeta Brain Research Center, Pasqual Maragall Foundation'}, 'officialTitle': "T1rho: Detection of Cerebral Proteinopathy in Alzheimer's Disease Through Magnetic Resonance Imaging", 'orgStudyIdInfo': {'id': 'T1rho/BBRC2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Cognitive impairment. Alzheimer's disease", 'description': 'Diagnosed with AD as defined per the International Working Group IWG 2 criteria (fulfilling core clinical criteria plus positive core AD CSF biomarkers)', 'interventionNames': ['Other: No intervention']}, {'label': "Cognitively unimpaired, preclinical Alzheimer's disease", 'description': 'Normal cognition as defined by the ALFA study cognitive workup Positive amyloid PET in the last 30 months', 'interventionNames': ['Other: No intervention']}, {'label': 'Cognitively unimpaired, control', 'description': 'Normal cognition as defined by the ALFA study cognitive workup Negative amyloid PET in the last 30 months', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'No intervention', 'armGroupLabels': ["Cognitive impairment. Alzheimer's disease", 'Cognitively unimpaired, control', "Cognitively unimpaired, preclinical Alzheimer's disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '08005', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Barcelonabeta Brain Research Center', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Barcelonabeta Brain Research Center, Pasqual Maragall Foundation', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hospital Clinic of Barcelona', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}