Ignite Creation Date:
2025-12-24 @ 5:58 PM
Ignite Modification Date:
2026-01-22 @ 7:25 AM
Study NCT ID:
NCT01754168
Status:
COMPLETED
Last Update Posted:
2018-03-08
First Post:
2012-12-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Amyloid Beta and Cognition in Parkinson Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva samples with DNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-07', 'studyFirstSubmitDate': '2012-12-13', 'studyFirstSubmitQcDate': '2012-12-20', 'lastUpdatePostDateStruct': {'date': '2018-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cholinergic innervation', 'timeFrame': 'Change from Baseline in cholinergic innervation at 2 years', 'description': 'FEOBV PET scan'}, {'measure': 'Cortical Amyloid Beta plaques', 'timeFrame': 'Change from Baseline in beta-amyloid deposition at 2 years', 'description': 'PIB PET scan'}, {'measure': 'Cognitive function', 'timeFrame': 'Change from Baseline in cognitive function at 2 years', 'description': 'Detailed neuropsychological test battery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Parkinson disease', 'Cognition'], 'conditions': ['Parkinson Disease', 'Neurological Disorders']}, 'descriptionModule': {'briefSummary': 'The investigators propose to study persons with Parkinson Disease (PD) with detailed clinical, cognitive and imaging at the time of study entry and repeat these assessments 2 years later. The study looks at how changes in activity of the neurotransmitter acetylcholine relates to changes in cognitive function and to see if there is presence or build up of amyloid protein.', 'detailedDescription': 'Participants with PD will be studied at initial visit assessing clinical, cognitive, and brain imaging. A one year and, if applicable, three year cognitive assessment will be done, and the entire/complete assessment (same as initial visit) will be repeated again at two years. There will be a maximum of three follow up visits. The imaging test battery will consist of amyloid and acetylcholine brain PET and MRI scans. The use of acetylcholine PET imaging will demonstrate how changes in activity of this neurotransmitter relate to changes in cognitive functions, such as memory and mental concentration. A key question will be whether persons with PD who not only are losing acetylcholine brain cells but also have the buildup of the Alzheimer amyloid protein have a more rapid progression with more severe cognitive decline and behavioral changes compared to persons who do not have the amyloid protein.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '65 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'UM and VA Movement Disorders Clinic\n\nPrimary Care Clinic\n\nCommunity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPD diagnosis according to the UK PD Society of Brain Bank research Center criteria PD subjects at risk for dementia Age 50 and above, male or female Absence of dementia confirmed by clinical and detailed neurological assessment -\n\nExclusion Criteria:\n\nSubjects with contra-indications to MR imaging Evidence of large vessel stroke or mass on on MRI Use of cholinergic or neuroleptic drugs at baseline Evidence of atypical parkinsonism on neurological exam Subjects limited by participation in research procedures involving ionizing radiation Pregnancy(test within 48 hours of each PET session) or breastfeeding\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01754168', 'briefTitle': 'Amyloid Beta and Cognition in Parkinson Disease', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'The Role of Amyloid Beta in the Progression of Cognitive Impairment in PD: A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'HUM00071121'}}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Nicolaas Bohnen, M.D., Phd', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Roger Albin, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}, {'name': 'Martijn Muller, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Radiology and Neurology', 'investigatorFullName': 'Nicolaas Bohnen, MD, PhD', 'investigatorAffiliation': 'University of Michigan'}}}}