Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-04-14 @ 1:03 PM
Study NCT ID:
NCT01303133
Status:
COMPLETED
Last Update Posted:
2019-01-09
First Post:
2011-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Natural History of Amyloid Deposition in Adults With Down Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004314', 'term': 'Down Syndrome'}, {'id': 'D058225', 'term': 'Plaque, Amyloid'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D008607', 'term': 'Intellectual Disability'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000015', 'term': 'Abnormalities, Multiple'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D025063', 'term': 'Chromosome Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Trisomy 21 ApoE'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-07', 'studyFirstSubmitDate': '2011-02-22', 'studyFirstSubmitQcDate': '2011-02-22', 'lastUpdatePostDateStruct': {'date': '2019-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Amyloid deposition', 'timeFrame': 'every 36 months for 9 years', 'description': 'Obtained via PiB PET scan'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ["beta amyloid, Down Syndrome, Alzheimer's Disease"], 'conditions': ['Down Syndrome']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to assess the presence of amyloid in non-demented/functionally stable adults with DS as a function of age, dividing the sample into amyloid-positive and amyloid-negative groups. We will also obtain baseline cognitive measures across a range of areas that are often affected by AD.', 'detailedDescription': 'Specific Aim 1: To assess and compare amyloid deposition (with PiB PET) in non-demented/functionally stable adults with DS across three age cohorts (30-39, 40-49, and \\>50 years of age).\n\nPrimary Hypothesis 1: At initial assessment, there will be a significantly higher prevalence of amyloid-positive (PiB+) subjects in each succeeding age cohort.\n\nIn addition, we will test the following secondary hypothesis:\n\nSecondary Aim 1: To compare the presence or absence of the apolipoprotein-E4 allele to the retention of PiB in various brain areas of the DS subjects.\n\nSecondary Hypothesis 1: At baseline, subjects who carry at least one Apolipoprotein-E4 (ApoE4) allele will show a higher prevalence of being PiB+.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Non-Demented Adults with Down Syndrome, ages 30 and above', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Participant IQ at least 47 (based upon Stanford-Binet V Abbrev. Test Battery)\n2. Participant at least 30 years of age\n3. DSDS score indicating participant is asymptomatic for AD\n4. Reliable caregiver who is capable of providing correct information about the participant\'s clinical symptoms and history\n5. Agreement of caregiver and clinician that participant is able to cooperate with the protocol tasks\n6. Participant has provided assent (or consent) and/or parent/caregiver has provided informed consent\n\nExclusion Criteria:\n\n1. Participant is non-verbal or has extremely limited language skills\n2. Score within the "symptomatic" range on the DSDS\n3. Any significant disease or unstable medical condition that could affect neuropsychological testing\n4. Any problems with vision or hearing that could affect neuropsychological testing\n5. Participants in whom MRI is contraindicated\n6. Claustrophobia or prior failed experiences of completing MRI scans or blood draws\n7. Participant is pregnant or breast feeding\n8. History or other evidence of severe illness or other condition that would make the participant, in the opinion of the investigator, unsuitable for the study?'}, 'identificationModule': {'nctId': 'NCT01303133', 'briefTitle': 'Natural History of Amyloid Deposition in Adults With Down Syndrome', 'nctIdAliases': ['NCT01412255'], 'organization': {'class': 'OTHER', 'fullName': 'University of Pittsburgh'}, 'officialTitle': 'Natural History of Amyloid Deposition in Adults With Down Syndrome', 'orgStudyIdInfo': {'id': 'PRO09080266'}, 'secondaryIdInfos': [{'id': '2R01AG031110-03A1', 'link': 'https://reporter.nih.gov/quickSearch/2R01AG031110-03A1', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with Down Syndrome ages 30+ (PiB-/-)', 'description': 'We will be recruiting healthy adults with Down syndrome ages 30 and over. Participants cannot have a diagnosis of dementia.'}, {'label': 'Adults with Down Syndrome ages 30+ (PiB-/+)'}, {'label': 'Adults with Down Syndrome ages 30+ (PiB+/+)'}]}, 'contactsLocationsModule': {'locations': [{'zip': '15203', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh and University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Waisman Center at the University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Benjamin Handen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pittsburgh'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pittsburgh', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Benjamin L Handen, PhD, BCBA-D', 'investigatorAffiliation': 'University of Pittsburgh'}}}}