Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 1:14 AM
Study NCT ID:
NCT07154394
Status:
RECRUITING
Last Update Posted:
2025-09-04
First Post:
2025-05-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cardiac Amyloid Deposits and Heart Dysfunction in Alzheimer's Disease
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': 'D028227', 'term': 'Amyloid Neuropathies, Familial'}], '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': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D017772', 'term': 'Amyloid Neuropathies'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D028226', 'term': 'Amyloidosis, Familial'}, {'id': 'D008661', 'term': 'Metabolism, Inborn Errors'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D000686', 'term': 'Amyloidosis'}, {'id': 'D057165', 'term': 'Proteostasis Deficiencies'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2025-09-14', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2025-05-20', 'studyFirstSubmitQcDate': '2025-08-26', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Frequency of occurrence of cardiac amyloid deposits in patients with a diagnosis of Alzheimer's disease (overall)", 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Frequency of occurrence of cardiac amyloid deposits in relation to different disease manifestations (subdivided, for example, by clinical assessment of disease stage)', 'timeFrame': 'through study completion, an average of 1 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia, Alzheimer Type', 'Mild Cognitive Impairment', 'Cardiac Amyloidosis']}, 'descriptionModule': {'briefSummary': "This study seeks to explore the possible common pathogenesis of both cardiac amyloidosis and Alzheimer's disease, which can both be associated with amyloid deposits. Using Positron Emission Tomography (PET) scans with amyloid tracers - a conventional tool for non-invasively imaging amyloid deposits in Alzheimer's disease - the research will extend this imaging methodology to the heart.\n\nThe study will conduct additional PET/MRI scans of the heart in patients undergoing amyloid tracer PET scans for Alzheimer's evaluations. Each participant will also undergo an echocardiogram and a clinical examination of dementia.\n\nThis could potentially enhance diagnostic practices in both cardiac amyloidosis and Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "The study population consists of patients who have been clinically referred for a cerebral amyloid PET examination to clarify a diagnosis of Alzheimer's disease.\n\nThe study aims to recruit a diverse group of patients, aged 50-90 years, with a minimum of 7 years of education and good knowledge of the German language. Patients will be accompanied by a companion during the study.\n\nExcluded from the study will be patients with vascular dementia or other confirmed causes of dementia, such as stroke, vitamin deficiency, thyroid insufficiency, or toxic causes like alcohol. Additionally, patients with pronounced cardiac preconditions, pregnant women, and breastfeeding women will be excluded.\n\nThe study population will be recruited from a clinical setting, where patients are undergoing routine diagnostic tests for Alzheimer's disease.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients undergoing cerebral amyloid PET examination for clinical indication to clarify Alzheimer's disease\n* No contraindications to undergo an MRI examination\n* No contraindications to undergo an Amyloid PET scan\n\nExclusion Criteria:\n\n* Patients with vascular dementia and confirmed other causes of dementia (e.g. stroke, vitamin deficiency, thyroid insufficiency, toxic causes such as alcohol)\n* Patients with pronounced cardiac preconditions\n* Pregnant and breastfeeding women"}, 'identificationModule': {'nctId': 'NCT07154394', 'briefTitle': "Cardiac Amyloid Deposits and Heart Dysfunction in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Essen'}, 'officialTitle': "Investigation of Cardiac Amyloid Deposits as a Cause of Cardiac Dysfunction in Alzheimer's Disease (Untersuchung Von Kardialen Amyloidablagerungen Als Ursache Einer Funktionseinschränkung Des Herzens Bei Alzheimer Demenz)", 'orgStudyIdInfo': {'id': '20-9291-BO'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Patients referred for cerebral amyloid PET to clarify Alzheimer's disease", 'description': "The study population consists of patients who have been clinically referred for a cerebral amyloid PET examination to clarify a diagnosis of Alzheimer's disease.\n\nThe study population will undergo a comprehensive diagnostic evaluation, which includes:\n\n* An extension of the amyloid PET examination to include cardiac PET/MRI imaging. No additional substances are applied and there is no additional radiation exposure.\n* A transthoracic echocardiogram, including strain analysis\n* A 12-lead electrocardiogram (EKG)"}]}, 'contactsLocationsModule': {'locations': [{'zip': '45147', 'city': 'Essen', 'state': 'North Rhine-Westphalia', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'David Kersting, MD PhD', 'role': 'CONTACT', 'email': 'david.kersting@uk-essen.de', 'phone': '+49-201-723-2073'}], 'facility': 'University Hospital Essen', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}], 'centralContacts': [{'name': 'David Kersting, MD PhD', 'role': 'CONTACT', 'email': 'david.kersting@uk-essen.de', 'phone': '+49-201-723-2073'}, {'name': 'Stephan Settelmeier, MD', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Essen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}