Ignite Creation Date:
2025-12-25 @ 4:25 AM
Ignite Modification Date:
2025-12-26 @ 3:28 AM
Study NCT ID:
NCT01421420
Status:
UNKNOWN
Last Update Posted:
2015-06-12
First Post:
2011-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Alzheimer's Disease Core Center
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'blood, saliva, brain tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 900}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-06-10', 'studyFirstSubmitDate': '2011-07-25', 'studyFirstSubmitQcDate': '2011-08-19', 'lastUpdatePostDateStruct': {'date': '2015-06-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-08-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neuropsychological Test Scores', 'timeFrame': 'Up to 20 years', 'description': 'Cognitive function will be evaluated on a yearly basis using a battery of neuropsychological tests, which will then be scored and normed according to established guidelines.'}], 'secondaryOutcomes': [{'measure': 'Neurological Exam', 'timeFrame': 'Up to 20 Years', 'description': 'A thorough neurological exam will be performed once per year to evaluate neurological function.'}, {'measure': 'Brain Tissue', 'timeFrame': 'From date of entry until date of death assessed up to 20 years', 'description': "A brain autopsy will be performed upon the participant's death to establish histological diagnosis."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's", 'Dementia', 'Mild Cognitive Impairment'], 'conditions': ["Alzheimer's Disease", 'Mild Cognitive Impairment', 'Age-Related Memory Disorders']}, 'descriptionModule': {'briefSummary': "The main objective of this research project is to provide a comprehensive clinical database of patients with Alzheimer's disease (AD) and other forms of dementia, individuals with mild cognitive impairment (MCI), and age-matched normal controls. The study will also attempt to identify cognitively normal individuals at genetically defined risk for Alzheimer's disease through genetic screening.\n\nAll participants are seen annually. Autopsies to establish diagnoses in patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.", 'detailedDescription': 'All participants are seen annually. In addition to a detailed neurological examination, participants will receive a standardized battery of neuropsychological tests and will undergo genetic testing. The investigators will provide standardized periodic longitudinal assessment of the research participants. Autopsies to establish neurohistopathological diagnoses in clinically well-characterized patients with dementia, patients with mild MCI, and cognitively normal elderly control subjects will also be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Individuals with Alzheimer's disease, mild cognitive impairment, other forms of dementia, and normal elderly individuals.", 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients with MCI, or dementia, the presence of cognitive deficits including memory, language, and executive function.\n\nExclusion Criteria:\n\nPresence of non-neurological medical conditions interfering with cognition.'}, 'identificationModule': {'nctId': 'NCT01421420', 'acronym': 'ADCC', 'briefTitle': "Alzheimer's Disease Core Center", 'organization': {'class': 'OTHER', 'fullName': 'University of Arizona'}, 'officialTitle': "Arizona Alzheimer's Disease Core Center", 'orgStudyIdInfo': {'id': 'P30AG019610', 'link': 'https://reporter.nih.gov/quickSearch/P30AG019610', 'type': 'NIH'}, 'secondaryIdInfos': [{'id': 'P30AG019610', 'link': 'https://reporter.nih.gov/quickSearch/P30AG019610', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Alzheimer's Disease"}, {'label': 'Mild Cognitive Impairment'}, {'label': 'Other forms of Dementia, not AD'}, {'label': 'Normal Elderly Individuals'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Kim Corley, B.A.', 'role': 'CONTACT', 'email': 'kgcorley@email.arizona.edu', 'phone': '520-626-3746'}, {'name': 'Steven Z Rapcsak, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Arizona, University Medical Center', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}], 'overallOfficials': [{'name': 'Steven Z Rapcsak, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Arizona'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Arizona', 'class': 'OTHER'}, 'collaborators': [{'name': 'Banner Health', 'class': 'OTHER'}, {'name': 'Barrow Neurological Foundation', 'class': 'OTHER'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}, {'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}