Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2026-01-13 @ 3:07 PM
Study NCT ID:
NCT05443308
Status:
UNKNOWN
Last Update Posted:
2022-07-05
First Post:
2022-06-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D015140', 'term': 'Dementia, Vascular'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'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': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D002537', 'term': 'Intracranial Arteriosclerosis'}, {'id': 'D020765', 'term': 'Intracranial Arterial Diseases'}, {'id': 'D056784', 'term': 'Leukoencephalopathies'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2023-04-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-29', 'studyFirstSubmitDate': '2022-06-23', 'studyFirstSubmitQcDate': '2022-06-29', 'lastUpdatePostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular reserve perfusion', 'timeFrame': '20 min after diamox infusion', 'description': 'Brain perfusion after diamox infusion (mL / min / 100 g tissue)'}, {'measure': 'Vascular reserve change', 'timeFrame': '20 min after diamox infusion', 'description': 'Change in Brain perfusion after diamox infusion (mL / min / 100 g tissue and %) compared to before diamox infusion'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Positron-Emission Tomography', 'Perfusion'], 'conditions': ['Alzheimer Disease', 'Dementia, Vascular']}, 'descriptionModule': {'briefSummary': 'Alzheimers disease and cerebral small vessel disease have a considerably overlap in patients and have common risk factors. The diseases are difficult to separate in individual patients and we hypothesize that a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease.\n\nPatients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative \\[15O\\]H2O positron emission tomography (PET) for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional \\[15O\\]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.', 'detailedDescription': 'Alzheimers disease and cerebral small vessel disease are increasingly common in the elderly population and constitute around 90% of new dementia cases in Denmark. The diseases have a considerably overlap in patients and have common risk factors. The cause of dementia can be difficult to separate in individual patients but a reduced cerebral vascular reserve may be a measurement of small vessel disease independent of Alzheimers disease. We hypothesized that patient with small vessel disease have reduced increase in brain perfusion after medical brain vessel dilatation. While Alzheimer patients may have reduced perfusion in rest but normal increase after medical brain vessel dilatation as compared to healthy subjects.\n\nPatients with presumed Alzheimers disease (n=20), cerebral small vessel disease (n=20) and healthy age-matched subjects (n=15) are examined with quantitative \\[15O\\]H2O PET for measurements of brain perfusion before and after diamox infusion that dilates cerebral vessels. Additional \\[15O\\]H2O PET scans of the heart allows for a non-invasive input function so the cerebral vascular reserve can be measured quantitatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Recruited from Department of Neurology, and Department of Geriatric and Palliative Medicine at Bispebjerg Hospital, Copenhagen, Denmark.\n\nHealthy subjects are recruited from internet advertisments.', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* presumed Alzheimer's Disease (group 1)\n* diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction (group 2)\n\nExclusion Criteria:\n\n* major claustrophobia\n* major psychiatric diseases\n* other major somatic diseases\n* allergy to diamox"}, 'identificationModule': {'nctId': 'NCT05443308', 'briefTitle': 'Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease', 'organization': {'class': 'OTHER', 'fullName': 'Bispebjerg Hospital'}, 'officialTitle': 'Cerebral Vascular Reserve in Small Vessel Disease and Alzheimers Disease', 'orgStudyIdInfo': {'id': 'H-21076058'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alzheimer Disease', 'description': 'patients with presumed Alzheimer disease and no known vascular, psychiatric or other major diseases age \\> 60 years', 'interventionNames': ['Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion']}, {'label': 'Small vessel disease', 'description': 'patients diagnosed with small vessel disease of the brain by MRI and presumed cognitive dysfunction and no other known psychiatric or other major diseases.\n\nage \\> 60 years', 'interventionNames': ['Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion']}, {'label': 'Healthy subjects', 'description': 'Age-matched subjects with no known vascular, psychiatric or other major diseases.\n\nage \\> 60 years', 'interventionNames': ['Diagnostic Test: Cerebral [15O]H2O PET before and after diamox infusion']}], 'interventions': [{'name': 'Cerebral [15O]H2O PET before and after diamox infusion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cerebral \\[15O\\]H2O PET before and after diamox infusion', 'armGroupLabels': ['Alzheimer Disease', 'Healthy subjects', 'Small vessel disease']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2400', 'city': 'Copenhagen', 'state': 'Copenhagen NV', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lisbeth Marner', 'role': 'CONTACT', 'email': 'lisbeth.marner@regionh.dk', 'phone': '+4591171938'}], 'facility': 'Department of Clinical Physiology and Nuclear Medicine, Copenhagen University Hospital Bispebjerg', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Lisbeth Marner, MD, PhD', 'role': 'CONTACT', 'email': 'lisbeth.marner@regionh.dk', 'phone': '+4591171938'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Data will be available at reasonable request following Danish laws on personal data regulations.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bispebjerg Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Associate professor', 'investigatorFullName': 'Lisbeth Marner', 'investigatorAffiliation': 'Bispebjerg Hospital'}}}}