Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-03-01 @ 9:59 AM
Study NCT ID:
NCT02059356
Status:
TERMINATED
Last Update Posted:
2015-03-17
First Post:
2014-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ammonia Levels and Cognitive Impairment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D007859', 'term': 'Learning Disabilities'}, {'id': 'D008569', 'term': 'Memory Disorders'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D022124', 'term': 'Hyperammonemia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D003147', 'term': 'Communication 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'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 17}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Low patient recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'lastUpdateSubmitDate': '2015-03-13', 'studyFirstSubmitDate': '2014-01-06', 'studyFirstSubmitQcDate': '2014-02-07', 'lastUpdatePostDateStruct': {'date': '2015-03-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood ammonia level', 'timeFrame': 'Baseline, Pretreatment and 3 months after treatment'}], 'secondaryOutcomes': [{'measure': 'Change in mini-status examination', 'timeFrame': 'Prior to treatment and 3 months after treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Dementia', "Alzheimer's", 'Alzheimers', 'Cognitive decline', 'Cognitive impairment', 'Memory loss', 'Memory disorder', 'Forgetfulness', 'Confusion', 'Senile', 'Demented', 'Developmental delay', 'Portal systemic shunting', 'High ammonia level', 'Elevated ammonia level'], 'conditions': ['Dementia', 'Cognitive Decline', 'Cognitive Impairment', 'Developmental Delay']}, 'descriptionModule': {'briefSummary': "The purpose and objective of this study is to determine the prevalence of elevated ammonia levels in subjects with cognitive impairment, and to observe if treating the cause of the elevated ammonia level improves mental status. This study does not include any imaging, treatment,or interventions, other than the blood draws. The blood draws will be taken to assess blood ammonia level and liver function. If the the ammonia level is not elevated, no further lab draws will occur. If the ammonia level is elevated, liver function is normal, and a cause for the high ammonia level is revealed with a plan for clinical treatment by the subjects' physician, then two more blood draws will occur; one prior to treatment, and one 3 months after treatment. The main risk to subjects is related to the blood draw (i.e. momentary discomfort, bruising, infection, bleeding, clotting or fainting), and there is a potential loss of confidentiality. A paired student t test will be done with the two later blood to compare objective data."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Residents of assisted living center or the general public', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* cognitive decline (suspected or documented)\n* able to get blood drawn\n\nExclusion Criteria:\n\n* liver disease/cirrhosis'}, 'identificationModule': {'nctId': 'NCT02059356', 'briefTitle': 'Ammonia Levels and Cognitive Impairment', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Prevalence of High Ammonia Levels in Patients With Cognitive Impairment. Does Treatment Help?', 'orgStudyIdInfo': {'id': 'Pro00048143'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Non-cirrhotic patients with cognitive impairment'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Hospital', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}