Ignite Creation Date:
2025-12-24 @ 4:05 PM
Ignite Modification Date:
2026-01-01 @ 7:16 PM
Study NCT ID:
NCT03746366
Status:
COMPLETED
Last Update Posted:
2024-12-13
First Post:
2018-11-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
[C-11]PiB PET Imaging in Alcohol Use Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000437', 'term': 'Alcoholism'}], 'ancestors': [{'id': 'D019973', 'term': 'Alcohol-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045002', 'term': '3-alpha-Hydroxysteroid Dehydrogenase (B-Specific)'}, {'id': 'C475519', 'term': "2-(4'-(methylamino)phenyl)-6-hydroxybenzothiazole"}], 'ancestors': [{'id': 'D015096', 'term': '3-Hydroxysteroid Dehydrogenases'}, {'id': 'D006913', 'term': 'Hydroxysteroid Dehydrogenases'}, {'id': 'D000429', 'term': 'Alcohol Oxidoreductases'}, {'id': 'D010088', 'term': 'Oxidoreductases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D064430', 'term': 'NAD (+) and NADP (+) Dependent Alcohol Oxidoreductases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '\\[C-11\\]PiB'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-09', 'studyFirstSubmitDate': '2018-11-16', 'studyFirstSubmitQcDate': '2018-11-16', 'lastUpdatePostDateStruct': {'date': '2024-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '[C-11]PIB +', 'timeFrame': 'Baseline', 'description': 'positive/negative'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alcohol Use Disorder']}, 'referencesModule': {'references': [{'pmid': '33934110', 'type': 'DERIVED', 'citation': 'Flanigan MR, Royse SK, Cenkner DP, Kozinski KM, Stoughton CJ, Himes ML, Minhas DS, Lopresti B, Butters MA, Narendran R. Imaging beta-amyloid (Abeta) burden in the brains of middle-aged individuals with alcohol-use disorders: a [11C]PIB PET study. Transl Psychiatry. 2021 May 1;11(1):257. doi: 10.1038/s41398-021-01374-y.'}]}, 'descriptionModule': {'briefSummary': 'To determine whether alcoholics (AUD) have a greater rate of amyloid positivity (ABeta+) compared to an age-matched cognitively normal control group (HC).', 'detailedDescription': 'There is a long-established relationship between alcohol use disorders (AUD), cognitive impairments, and the development of dementia. Some, but not all basic data suggest that alcohol abuse can alter the expression of amyloid precursor protein, and the enzymes that process it. Thus, there is a need for in vivo PET studies to further investigate the relationship between AUD and AD and the mechanism through which alcohol abuse exerts its effect on this type of dementia. Here, we propose to use the amyloid Beta (ABeta) radiotracer carbon-11 labeled Pittsburgh Compound-B (\\[C-11\\]PiB) and PET (Klunk et al., 2004) to determine whether AUD increase the risk to be brain ABeta+ in middle aged adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "\\[A\\] Alcohol Use Disorder Subjects (AUD)\n\nInclusion Criteria:\n\n1. Males or females between 40 and 65 years old\n2. Fulfill DSM-5 criteria for alcohol use disorder of at least moderate severity\n3. Current heavy drinking as defined in SAMHSA criteria (i.e., drinking 5 or more drinks on the same occasion on each of 5 or more days in the past 30 days)\n\nExclusion Criteria:\n\n1. DSM-5 schizophrenia, schizoaffective disorder, bipolar disorder (SCID-5) and prior history of developmental disorders, such as Autism, Down's Syndrome, Intellectual disability.\n2. A positive urine drug screen at screening for amphetamines, cocaine, methamphetamine, opioids, barbituates and PCP\n3. History of severe unstable medical or neurological illnesses that could affect neuropsychological testing\n4. History of cancer (other than skin or in situ prostate cancer) within the previous 5 years\n5. Currently pregnant or breastfeeding\n6. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year\n7. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan\n8. No first-degree relative with Alzheimer's disease or related dementias\n\n(B) Healthy Control Subjects (HC)\n\nInclusion Criteria:\n\n(1) Males or females between 40 and 65 years old\n\nExclusion criteria:\n\n1. Current or past DSM-5 psychiatric and/or addictive disorders\n2. Current heavy drinking as defined in SAMHSA criteria\n3. History of severe unstable medical or neurological illnesses that could affect neuropsychological testing\n4. History of cancer (other than skin or in situ prostate cancer) within the previous 5 years\n5. Currently pregnant or breastfeeding\n6. Currently employed as radiation worker; or participation in radioactive drug research protocols within the previous year\n7. Metal implants or paramagnetic objects contained within the body which may interfere with the MRI scan\n8. No first-degree relative with Alzheimer's disease or related dementias"}, 'identificationModule': {'nctId': 'NCT03746366', 'briefTitle': '[C-11]PiB PET Imaging in Alcohol Use Disorders', 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': "Imaging Beta-amyloid in Middle Age Alcoholics As a Mechanism That Increases Their Risk for Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'PRO18080481'}, 'secondaryIdInfos': [{'id': 'R01AA025247', 'link': 'https://reporter.nih.gov/quickSearch/R01AA025247', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alcohol use disorders', 'description': '\\[C-11\\]Pittsburgh Compound B (PiB) PET scan', 'interventionNames': ['Radiation: [C-11]', 'Drug: Pittsburgh Compound B']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy controls', 'description': '\\[C-11\\]Pittsburgh Compound B (PiB) PET scan', 'interventionNames': ['Radiation: [C-11]', 'Drug: Pittsburgh Compound B']}], 'interventions': [{'name': '[C-11]', 'type': 'RADIATION', 'description': 'Radiolabel', 'armGroupLabels': ['Alcohol use disorders', 'Healthy controls']}, {'name': 'Pittsburgh Compound B', 'type': 'DRUG', 'description': 'Tracer', 'armGroupLabels': ['Alcohol use disorders', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsbyurgh PET Facility', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Alcohol Abuse and Alcoholism (NIAAA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology and Psychiatry', 'investigatorFullName': 'Rajesh Narendran', 'investigatorAffiliation': 'University of Pittsburgh'}}}}