Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2025-12-27 @ 3:51 AM
Study NCT ID:
NCT01574456
Status:
COMPLETED
Last Update Posted:
2013-12-10
First Post:
2012-04-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Blood-brain Barrier Permeability 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': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 39}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-12-09', 'studyFirstSubmitDate': '2012-04-05', 'studyFirstSubmitQcDate': '2012-04-09', 'lastUpdatePostDateStruct': {'date': '2013-12-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The main study measures are blood brain barrier permeability as measured by T1-weighted dynamic contrast MRI', 'timeFrame': '22 months'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': 'The main aim of the present study is to improve our understanding of the role of blood-brain barrier function in dementia of the Alzheimer\'s type. The investigators hypothesize that microvascular dysfunction - more specifically "cerebral perfusion and blood-brain barrier leakage" - is a determinant of cognitive decline and cortical atrophy in Alzheimer\'s disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Three groups of participants have been included: 7 patients diagnosed with dementia of the Alzheimer's type; 13 patients with mild cognitive impairment due to AD, which represents a preclinical stage of AD in which patients already have memory impairment and at least one AD biomarker (i.e. hippocampal atrophy or abnormal amyloid and tau protein content in the cerebrospinal fluid); and 19 healthy controls. Patients have been recruited from the memory clinics of the Maastricht University Medical Center and the Leiden University Medical Center.", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nPatients with AD:\n\n* Informed consent before participation in the study\n* Received standard diagnostic procedure according to the Parelsnoer Initiative procedure\n* Diagnosed with dementia of the Alzheimer's type\n* Clinical dementia rating (CDR) of 1, which means a mild to moderate stage of dementia\n* MMSE ≥ 20 and patients are mentally competent (in general, individuals with an MMSE ≥ 18 are considered mentally competent)\n\nPatients with prodromal AD:\n\n* Informed consent before participation in the study\n* Received standard diagnostic procedure according to the Parelsnoer Initiative procedure\n* Diagnosis of prodromal dementia according to the Dubois criteria (16)\n* CDR of 0.5, which suggests a very mild stage of dementia\n* Memory impairment defined as Delayed Recall on Verbal Learning Test (15 WLT) \\< 1.5 SD\n* MMSE ≥ 20 and patients are mentally competent.\n* Medial temporal lobe atrophy scale MTA ≥ 1 (17) OR abnormal levels of Aß42, t-tau or p-tau\n\nHealthy participants:\n\n* Informed consent before participation in the study\n* No Diagnosis of dementia, prodromal dementia, or mild cognitive impairment.\n* MMSE ≥ 26\n* No substantial memory complaints (according to participant)\n* Age, gender and education is matched to the patient groups.\n\nExclusion Criteria:\n\n* Contraindications for scanning (e.g. brain surgery, cardiac pacemaker, metal implants, claustrophobia, large body tattoos)\n* Contraindications for contrast agent Gadovist (renal failure) as determined by the estimated Glomular Filtration Rate eGFR \\< 30 mL/min.\n* Major vascular disorders (e.g. stroke, heart disease)\n* Psychiatric or neurological disorders: Major depression (\\< 12 months); history of schizophrenia; bipolar disorder; psychotic disorder NOS or treatment for a psychotic disorder (\\< 12 mnd); cognitive impairment due to alcohol abuse; epilepsy; Parkinson's disease; MS; brain surgery; brain trauma; electroshock therapy; kidney dialysis; Meniere's disease; and brain infections.\n* Structural abnormalities of the brain\n* Cognitive impairment due to alcohol/drug abuse\n* Absence of reliable informant (for patient groups)"}, 'identificationModule': {'nctId': 'NCT01574456', 'briefTitle': "Blood-brain Barrier Permeability in Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'orgStudyIdInfo': {'id': 'NL36156.068.11'}}, 'armsInterventionsModule': {'armGroups': [{'label': "7 patients diagnosed with dementia of the Alzheimer's type"}, {'label': '13 patients with mild cognitive impairment'}, {'label': '19 healthy controls'}]}, 'contactsLocationsModule': {'locations': [{'zip': '2333 ZA', 'city': 'Leiden', 'country': 'Netherlands', 'facility': 'Leids University Medical Center', 'geoPoint': {'lat': 52.15833, 'lon': 4.49306}}, {'zip': '6229 ET', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'Maastricht University Hospital', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}