Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2026-04-02 @ 12:23 PM
Study NCT ID:
NCT05402566
Status:
COMPLETED
Last Update Posted:
2023-12-01
First Post:
2022-05-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], '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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-30', 'studyFirstSubmitDate': '2022-05-25', 'studyFirstSubmitQcDate': '2022-05-30', 'lastUpdatePostDateStruct': {'date': '2023-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Deuterium Metabolic Imaging', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Glucose concentration in whole-brain referenced to baseline scan (sub-study 1).'}, {'measure': 'Deuterium Metabolic Imaging', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Lactate concentrations in whole-brain referenced to baseline scan (sub-study 1).'}, {'measure': 'Deuterium Metabolic Imaging', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Glx concentrations in whole-brain referenced to baseline scan (sub-study 1).'}, {'measure': 'Deuterium Metabolic Imaging', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Lactate/glx ratio in the tempo-parietal cortex (sub-study 2).'}, {'measure': 'Deuterium Metabolic Imaging', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Lactate/glx ratio in the hippocampus (sub-study 2).'}, {'measure': 'Deuterium Metabolic Imaging', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Lactate/glx ratio in the posterior cingulum (sub-study 2).'}], 'secondaryOutcomes': [{'measure': 'Deuterium Metabolic Imaging', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Simpler DMI quantifications, including reference to external phantoms and internal reference, in the same regions defined in primary outcomes.'}, {'measure': 'Blood samples', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': 'Glucose'}, {'measure': 'Blood samples', 'timeFrame': 'Up to 150 mins after 2H-glucose ingestion', 'description': '2H-enrichment'}, {'measure': 'FDG-PET from the records (sub study 2)', 'timeFrame': 'At time of Deuterium Metabolic Imaging', 'description': 'Brain glucose uptake'}, {'measure': 'Cognitive tests from the records (sub study 2)', 'timeFrame': 'At time of Deuterium Metabolic Imaging', 'description': 'The Mini-Mental State Exam (0-30, 30 is best)'}, {'measure': 'Cognitive tests from the records (sub study 2)', 'timeFrame': 'At time of Deuterium Metabolic Imaging', 'description': "Addenbrooke's Cognitive Examination (0-100, 100 is best)"}, {'measure': 'Cerebrospinal fluid biochemistry from the records (sub study 2)', 'timeFrame': 'At time of Deuterium Metabolic Imaging', 'description': 'Total tau protein'}, {'measure': 'Cerebrospinal fluid biochemistry from the records (sub study 2)', 'timeFrame': 'At time of Deuterium Metabolic Imaging', 'description': 'Phosphorylated tau'}, {'measure': 'Cerebrospinal fluid biochemistry from the records (sub study 2)', 'timeFrame': 'At time of Deuterium Metabolic Imaging', 'description': 'Amyloid'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '38472611', 'type': 'DERIVED', 'citation': 'Bogh N, Vaeggemose M, Schulte RF, Hansen ESS, Laustsen C. Repeatability of deuterium metabolic imaging of healthy volunteers at 3 T. Eur Radiol Exp. 2024 Mar 13;8(1):44. doi: 10.1186/s41747-024-00426-4.'}]}, 'descriptionModule': {'briefSummary': "Diseases of dementia are chronic, untreatable, and cause a massive burden of morbidity. In this proposal, we seek to tackle the problem of better, earlier, and more efficient diagnosis using deuterium metabolic imaging (DMI). The study is divided in two sub-studies: 1) optimization and simplification of DMI protocols, and 2) a cross-sectional study of DMI in Alzheimer's patients and healthy controls."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "In sub-study 1, the population is composed of healthy volunteers. In sub-study 2, patients with Alzheimer's disease and healthy age-matched controls are recruited.", 'eligibilityCriteria': 'Inclusion criteria:\n\nAD-patients:\n\n* Aged 55-85 years.\n* Male or female.\n* AD diagnosis by the NIA-AA 2011 research criteria.8\n* Able to give written informed consent.\n* Mini-mental state examination (MMSE) equal to or above 18.9\n* Brain FDG-PET performed at Aarhus University Hospital consistent with AD.\n\nHealthy participants:\n\n* Aged 18-85 years.\n* Male or female.\n\nExclusion criteria:\n\nAll participants:\n\n* Diabetes or any other metabolic disease.\n* Other significant brain disease:\n\n * Strokes.\n * Tumors.\n * Chronic small vessel disease (clinically suspected, or Fazekas ≥ 2 if clinical MRI is available).\n * Epilepsy.\n * Other neurodegenerative or -inflammatory disease.\n* Contraindications for MRI:\n\n * Pacemaker, neurostimulator or cochlear implant.\n * Metal foreign bodies such as fragments and irremovable piercings.\n * Unsafe medical implants (safety of heart valves, hips and the like must be confirmed).\n * Claustrophobia.\n * Largest circumference including arms \\> 160 cm.\n* Pregnant - women must be post-menopausal or confirmed non-pregnant by an onsite test.'}, 'identificationModule': {'nctId': 'NCT05402566', 'briefTitle': "MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': "MRI Assessment of Impaired Glucose Metabolism in Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'DMI-AD'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Healhy volunteers', 'description': 'Repeated MRI and DMI for simplification of protocols. Repeated within 6 +/- 2 weeks.', 'interventionNames': ['Diagnostic Test: Deuterium metabolic imaging']}, {'label': "Alzheimer's disease patients", 'description': 'MRI and DMI to assess cerebral glucose metabolism. Single examination. Compared with PET.', 'interventionNames': ['Diagnostic Test: Deuterium metabolic imaging']}, {'label': 'Healthy controls', 'description': 'MRI and DMI for comparison with AD patients.', 'interventionNames': ['Diagnostic Test: Deuterium metabolic imaging']}], 'interventions': [{'name': 'Deuterium metabolic imaging', 'type': 'DIAGNOSTIC_TEST', 'description': "MRI after oral administration of 75g of \\[6,6'-2H2\\]glucose.", 'armGroupLabels': ["Alzheimer's disease patients", 'Healhy volunteers', 'Healthy controls']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8200', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'After study is completed.', 'ipdSharing': 'YES', 'description': 'Data will be shared after study completion and full anonymization.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aarhus University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}