Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 5:36 AM
Study NCT ID:
NCT06448403
Status:
RECRUITING
Last Update Posted:
2025-08-07
First Post:
2024-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multimodal Assesment of Alzheimer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017286', 'term': 'Polysomnography'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D009483', 'term': 'Neuropsychological Tests'}], 'ancestors': [{'id': 'D008991', 'term': 'Monitoring, Physiologic'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011581', 'term': 'Psychological Tests'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-12-29', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-04', 'studyFirstSubmitDate': '2024-06-03', 'studyFirstSubmitQcDate': '2024-06-03', 'lastUpdatePostDateStruct': {'date': '2025-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'MCI-AD converters', 'timeFrame': '5 years', 'description': 'Identify biomarker profiles unique for patients with MCI that develop AD for earlier prediction.'}, {'measure': 'AD-subclassification', 'timeFrame': '5 years', 'description': 'Identify biomarker profiles that can assist in a more thorough AD-classification'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Alzheimer Disease (AD)', 'Mild cognitive impairment (MCI)', 'Brain Diseases', 'Nervous System Disorders', 'Neurodegenerative Diseases', 'Dementia', 'Cognitive impairment'], 'conditions': ['Mild Cognitive Impairment', 'Alzheimer Disease, Late Onset', 'Cognitive Impairment', 'Dementia']}, 'descriptionModule': {'briefSummary': "The goal of this study is to learn more about the changes in the brains of patients with cognitive impairment (MCI) and Alzheimer's Disease (AD).\n\nThe main questions the study aims to answer are:\n\n1. What findings can be used to earlier detect patients that will develop Alzheimers?\n2. Which differences are seen between healthy and cognitively impaired patients?\n3. Which differences are seen between patients with Alzheimers disease?\n\nParticipants will undergo:\n\n* Cognitive tests\n* Magnetic resonance imaging (MRI)\n* Electroencephalography (EEG)\n* Blood sample collection\n* Fecal sample collection\n* A randomized group will undergo polysomnography analysis.", 'detailedDescription': "The projects aims to map brain changes in patients with mild cognitive impairment (MCI) and Alzheimer's Disease (AD) by combining different assesment modalities.\n\nIn the MRI, researchers will get the opportunity to analyse both structural and functional brain changes. In the EEG, changes in elctrical activites will be measured. The blood samples allow researchers to analyse specific dementia and inflammation proteins, while fecal speciments can be used to assess bacterial composition. Additionally, the cognitive testing allow to assess the specific part of cognitive function which is affected."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is from Tronderlag in Norway, mainly in and around Trondheim city.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* MCI and AD according to relevant ICD-criterias.\n* Control cohort is age and gender matched with other cohorts.\n\nExclusion Criteria:\n\n* Uneligibility for any of the planned neuroimagery devices (MRI, EEG)\n* AD diagnosis before the age of 65 (Early-onset AD).\n* Brain tumor\n* Traumtic head injury\n* Earlier neurosurgery\n* Other neyrodegenerative diseases (i.e Parkinson and ALS)\n* Diseases related to inflammation and auto-immunity (i.e MS)'}, 'identificationModule': {'nctId': 'NCT06448403', 'acronym': 'MultiAD', 'briefTitle': 'Multimodal Assesment of Alzheimer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Norwegian University of Science and Technology'}, 'officialTitle': 'Multimodal Assessment of Cognitive Impairment in Alzheimer Patients', 'orgStudyIdInfo': {'id': '626476'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'MCI', 'description': 'Recruitment according to relevant clinical assessment and ICD-criterias.', 'interventionNames': ['Device: MRI Scanning', 'Device: 64-channel EEG', 'Device: Polysomnography', 'Biological: Blood samples', 'Biological: Fecal samples', 'Behavioral: Cognitive tests']}, {'label': 'Mild AD', 'description': 'Recruitment according to relevant clinical assessment and ICD-criterias.', 'interventionNames': ['Device: MRI Scanning', 'Device: 64-channel EEG', 'Device: Polysomnography', 'Biological: Blood samples', 'Biological: Fecal samples', 'Behavioral: Cognitive tests']}, {'label': 'Control', 'description': 'Equivalent number of research participants as in the MCI and mild AD group.', 'interventionNames': ['Device: MRI Scanning', 'Device: 64-channel EEG', 'Device: Polysomnography', 'Biological: Blood samples', 'Biological: Fecal samples', 'Behavioral: Cognitive tests']}], 'interventions': [{'name': 'MRI Scanning', 'type': 'DEVICE', 'description': 'MRI scanning with volumetric, resting and activity-based sequences.', 'armGroupLabels': ['Control', 'MCI', 'Mild AD']}, {'name': '64-channel EEG', 'type': 'DEVICE', 'description': 'EEG to quantifiy electric activity.', 'armGroupLabels': ['Control', 'MCI', 'Mild AD']}, {'name': 'Polysomnography', 'type': 'DEVICE', 'description': 'A randomized group will undergo polysomnography.', 'armGroupLabels': ['Control', 'MCI', 'Mild AD']}, {'name': 'Blood samples', 'type': 'BIOLOGICAL', 'description': 'Analysis of specific blood biomarkers.', 'armGroupLabels': ['Control', 'MCI', 'Mild AD']}, {'name': 'Fecal samples', 'type': 'BIOLOGICAL', 'description': 'Analysis of bacterial composition.', 'armGroupLabels': ['Control', 'MCI', 'Mild AD']}, {'name': 'Cognitive tests', 'type': 'BEHAVIORAL', 'description': 'Interview-based cognitive tests for assesment of cognitive levels.', 'armGroupLabels': ['Control', 'MCI', 'Mild AD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '7030', 'city': 'Trondheim', 'state': 'Trønderlag', 'status': 'RECRUITING', 'country': 'Norway', 'facility': 'Norwegian University of Sciene and Technology / Norges teknisk-naturvitenskapelige universitet (NTNU)', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'centralContacts': [{'name': 'Axel Sandvig, Prof., MD, PhD', 'role': 'CONTACT', 'email': 'axel.sandvig@ntnu.no', 'phone': '72 57 56 20'}], 'overallOfficials': [{'name': 'Axel Sandvig, Prof., MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Norwegian University of Science and Technology (NTNU) & St. Olavs Hospital, Trondheim University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}