Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2026-02-23 @ 8:09 PM
Study NCT ID:
NCT02640092
Status:
COMPLETED
Last Update Posted:
2019-12-23
First Post:
2015-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000710691', 'term': '(18F)GTP1'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-19', 'studyFirstSubmitDate': '2015-12-15', 'studyFirstSubmitQcDate': '2015-12-21', 'lastUpdatePostDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-06-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Standardized Uptake Value Ratio (SUVR) as Measured by [18F]GTP1', 'timeFrame': 'From Baseline to 18 months'}], 'secondaryOutcomes': [{'measure': "Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog)13", 'timeFrame': 'From Baseline to 18 months'}, {'measure': 'Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Volumetric Magnetic Resonance Imaging (MRI) Measures', 'timeFrame': 'From Baseline to 18 months'}, {'measure': 'Correlation Coefficient Between Change in SUVR (as Measured by [18F]GTP1) and Change in Cerebrospinal Fluid (CSF) Markers', 'timeFrame': 'From Baseline to 18 months'}, {'measure': 'Percentage of Participants With Adverse Events (AEs)', 'timeFrame': 'From Baseline to 18 months'}, {'measure': 'Test-Retest Variability Based on [18F]GTP1 PET Scans', 'timeFrame': 'From date of test scan to 7-21 days after test scan'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '38606196', 'type': 'DERIVED', 'citation': "Sanabria Bohorquez SM, Baker S, Manser PT, Tonietto M, Galli C, Wildsmith KR, Zou Y, Kerchner GA, Weimer R, Teng E. Evaluation of partial volume correction and analysis of longitudinal [18F]GTP1 tau PET imaging in Alzheimer's disease using linear mixed-effects models. Front Neuroimaging. 2024 Mar 28;3:1355402. doi: 10.3389/fnimg.2024.1355402. eCollection 2024."}, {'pmid': '34852837', 'type': 'DERIVED', 'citation': "Teng E, Manser PT, Sanabria Bohorquez S, Wildsmith KR, Pickthorn K, Baker SL, Ward M, Kerchner GA, Weimer RM. Baseline [18F]GTP1 tau PET imaging is associated with subsequent cognitive decline in Alzheimer's disease. Alzheimers Res Ther. 2021 Dec 1;13(1):196. doi: 10.1186/s13195-021-00937-x."}, {'pmid': '31834365', 'type': 'DERIVED', 'citation': 'Blennow K, Chen C, Cicognola C, Wildsmith KR, Manser PT, Bohorquez SMS, Zhang Z, Xie B, Peng J, Hansson O, Kvartsberg H, Portelius E, Zetterberg H, Lashley T, Brinkmalm G, Kerchner GA, Weimer RM, Ye K, Hoglund K. Cerebrospinal fluid tau fragment correlates with tau PET: a candidate biomarker for tangle pathology. Brain. 2020 Feb 1;143(2):650-660. doi: 10.1093/brain/awz346.'}]}, 'descriptionModule': {'briefSummary': "This is an open-label, longitudinal observational study evaluating the imaging characteristics of the tau positron-emission tomography (PET) radioligand \\[18F\\] Genentech Tau Probe 1 (GTP1) in the brain of participants with prodromal, mild, and moderate Alzheimer's disease (AD) compared to healthy participants. The overall goal of this protocol is to evaluate the longitudinal change in tau burden using \\[18F\\]GTP1, a tau targeted radiopharmaceutical."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nFor All Participants:\n\n\\- Availability of a study partner who, in the investigator's judgment, has frequent and sufficient contact with the participant and is able to provide accurate information regarding the participant's cognitive and functional abilities, agrees to accompany the participant and provide information at visits\n\nFor Healthy Participants:\n\n* Healthy with no clinically relevant finding on physical examination at screening and upon reporting for the Baseline \\[18F\\]GTP1 imaging visit\n* Have no cognitive complaint\n* Have a Clinical Dementia Rating Scale (CDR) global score = 0\n* Have a Mini-Mental State Examination (MMSE) score of 28-30\n\nFor Participants With a Diagnosis of AD:\n\n* Participants with mild or moderate AD must meet National Institute on Aging - Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia, with an amnestic presentation\n* Participants with prodromal AD must meet NIA-AA core clinical criteria for mild cognitive impairment (MCI)\n* Have screening \\[18F\\]florbetapir PET imaging demonstrating amyloid binding based on qualitative visual read\n* A brain MRI consistent with a diagnosis of AD, with no evidence of non-AD disease to account for dementia or MRI exclusion criteria\n* Medications taken for symptomatic treatment of AD must remain stable for at least 30 days prior to screening visit\n* Satisfy one of the following subgroups: Approximately 20 prodromal AD (MMSE 24-30, CDR = 0.5); Approximately 20 mild AD (MMSE 22-30, CDR = 0.5 or 1); Approximately 20 moderate AD (MMSE 16-21, CDR = 0.5 or 1 or 2)\n\nExclusion Criteria:\n\n* Current or prior history of any drug or alcohol abuse\n* Participants with any significant psychiatric, neurological, or unstable medical disorder expected to interfere with the study\n* Participants unable to undergo MRI and PET scan\n* For participants contributing CSF samples, any contraindication to lumbar puncture\n* Prior participation in other research protocols or clinical care in the last year such a radiation exposure combined with that from the present study exceeds an effective dose of 50 millisievert (mSV), the allowable annual limit for research participants as stipulated by the Food and Drug Administration (FDA)"}, 'identificationModule': {'nctId': 'NCT02640092', 'briefTitle': "Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Participants With Alzheimer's Disease Compared to Healthy Participants", 'organization': {'class': 'INDUSTRY', 'fullName': 'Genentech, Inc.'}, 'officialTitle': "Longitudinal Evaluation of [18F]GTP1 as a PET Radioligand for Imaging Tau in the Brain of Patients With Prodromal, Mild, and Moderate Alzheimer's Disease Compared to Healthy Volunteers", 'orgStudyIdInfo': {'id': 'GN30009'}, 'secondaryIdInfos': [{'id': 'G0097', 'type': 'OTHER', 'domain': 'InVicro'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]GTP1', 'description': 'Participants will complete \\[18F\\]GTP1 PET imaging at four time points: Baseline, 6 months, 12 months and 18 months. For each \\[18F\\]GTP1 imaging session, the following procedure will be performed: a catheter will be placed for intravenous (IV) administration of \\[18F\\]GTP1. Participants will receive an IV bolus injection of up to 370 megabecquerel (MBq) (10 millicurie \\[mCi\\]) of \\[18F\\]GTP1.', 'interventionNames': ['Drug: [18F]GTP1']}], 'interventions': [{'name': '[18F]GTP1', 'type': 'DRUG', 'otherNames': ['[18F]G02941054', '[18F]MNI-798', '[18F]RO6880276'], 'description': 'Participants will receive \\[18F\\]GTP1 as per the schedule specified in the arm description.', 'armGroupLabels': ['[18F]GTP1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Molecular NeuroImaging', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '06905', 'city': 'Stamford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'KI Health Partners, LLC; New England Institute for Clinical Research', 'geoPoint': {'lat': 41.05343, 'lon': -73.53873}}, {'zip': '33912', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Neuropsychiatric Research; Center of Southwest Florida', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33137', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Miami Jewish Health Systems', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Bioclinica Research', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '30303', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30033', 'city': 'Decatur', 'state': 'Georgia', 'country': 'United States', 'facility': 'NeuroStudies.net, LLC', 'geoPoint': {'lat': 33.77483, 'lon': -84.29631}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': "Acadia Clinical Research; Dr. Henderson's Office", 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '02360', 'city': 'Plymouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Donald S. Marks, M.D., P.C.; Medical Center', 'geoPoint': {'lat': 41.95844, 'lon': -70.66726}}, {'zip': '02169', 'city': 'Quincy', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Alzheimers Disease Center', 'geoPoint': {'lat': 42.25288, 'lon': -71.00227}}, {'zip': '07856', 'city': 'Mount Arlington', 'state': 'New Jersey', 'country': 'United States', 'facility': 'NeuroCognitive Institute', 'geoPoint': {'lat': 40.92593, 'lon': -74.63488}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Bio Behavioral Health', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Advanced Medical Research', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '18104', 'city': 'Allentown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Lehigh Center Clinical Research', 'geoPoint': {'lat': 40.60843, 'lon': -75.49018}}, {'zip': '02914', 'city': 'East Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Rhode Island Mood & Memory Research Institute', 'geoPoint': {'lat': 41.81371, 'lon': -71.37005}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Butler Hospital', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}], 'overallOfficials': [{'name': 'Clinical Trials', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hoffmann-La Roche'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}