Ignite Creation Date:
2025-12-25 @ 2:06 AM
Ignite Modification Date:
2025-12-27 @ 10:50 PM
Study NCT ID:
NCT04522960
Status:
UNKNOWN
Last Update Posted:
2022-05-18
First Post:
2020-08-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Melatonin in Alzheimer's Disease: Effect on Disease Progression and Epileptiform Activity.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013129', 'term': 'Spinal Puncture'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}], 'ancestors': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003943', 'term': 'Diagnostic Techniques, Neurological'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-17', 'studyFirstSubmitDate': '2020-08-13', 'studyFirstSubmitQcDate': '2020-08-18', 'lastUpdatePostDateStruct': {'date': '2022-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'CSF and blood melatonin levels in patients with AD dementia, MCI due to AD and healthy volunteers', 'timeFrame': '24 hours', 'description': 'Comparison of CSF and blood melatonin levels between patients with MCI and dementia due to AD and healthy volunteers.'}, {'measure': 'Blood, saliva and urine melatonin correlations', 'timeFrame': '24 hours', 'description': 'Correlation between blood melatonin and urinary and salivary melatonin in the AD continuum'}, {'measure': 'Melatonin influence on cognition', 'timeFrame': '2 years', 'description': 'Correlations between melatonin levels and cognitive performance over a 2 year time frame. This will be assessed by use of neuropsychological testing including MMSE, MoCA, RBANS, VAT, ...'}, {'measure': 'Melatonin influence on epileptiform activity', 'timeFrame': '8 weeks', 'description': 'Correlations between melatonin levels and (subclinical) epileptiform activity. Over a time frame of 8 weeks patients will undergo neuropsychological testing (with MMSE, MoCA, RBANS, VAT...), LTM-EEG monitoring (during 24 hours), MEG + hdEEG.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This is a long-term, prospective, observational study to investigate and compare the levels and rhythm of melatonin in patients with AD dementia, mild cognitive impairment due to AD and healthy volunteers. The investigators would like to validate the use of salivary and urine melatonin measurements as an alternative for blood/CSF melatonin. Furthermore, the investigators would like to assess the effects of melatonin levels on cognition by correlating the levels and changes on cognitive tasks over a two year time frame. The investigators will also investigate whether these effects could be due to its anticonvulsive properties.', 'detailedDescription': "Melatonin production gets disrupted in AD, as shown in post-mortem pineal glands and CSF of AD patients. CSF melatonin levels are known to significantly drop in patients with Alzheimer's dementia. It is known that CSF melatonin levels are much higher than blood melatonin levels, due to melatonin secretion from the pineal recess directly into the third ventricle. It has never been investigated whether blood melatonin accurately correlates with CSF melatonin in AD, nor whether saliva or urine melatonin levels accurately reflect blood/CSF melatonin in the AD continuum. The investigators want to validate the use of blood, saliva and urine melatonin levels as alternative for CSF melatonin in the AD continuum to pave the way for further use of less invasive collection techniques (blood, saliva, urine instead of CSF) and to possibly study circadian rhythm in a less disrupting, in home environment (saliva, urine).\n\nFurhtermore, melatonin exerts several potential anti-AD properties, including anti-inflammatory, anti-oxidant, tilting APP processing towards the non-amyloidogenic pathway, exerting positive effects on sleep and so on. In vivo studies furthermore point to anticonvulsive and antiepileptic effects of melatonin in a whole range of rodent models. Some evidence exists for a role of melatonin in prevention of epileptic seizures in humans.\n\nThe investigators want to investigate influence of melatonin on changes in cognition in a longitudinal way, and investigate influence on (sub)clinical epileptiform activity."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Dementia due to AD, according to National Institute on Aging-Alzheimer's Association (NIA-AA) criteria\n2. MCI due to AD, according to NIA-AA criteria\n3. Healthy controls: Age- and gender matched healthy controls\n\nExclusion Criteria:\n\nPatients (AD dementia, MCI)\n\n* Age \\< 18 years old\n* Pregnancy\n* Expected death due to illness within 2 years\n* Pacemaker or other ferrromagnetic material that is not MRI compatible\n* Other neurodegenerative or cerebrovascular disease\n* Pattern compatible with NPH (clinically, imaging)\n* Epilepsy\n* Multiple sclerosis or other demyelinating disease\n* Depression, psychosis or other mental disease\n* Use of anti-epileptic drugs\n* Alcohol or substance abuse\n* Korsakoff syndrome\n* Symptomatic liver disease\n* Uncontrolled thyroid disorders\n* Untreated HIV or syphilis\n* Clinically significant vitamin B12 deficiency\n* Severe systemic medical illness (eg end-stage cardiac disease, …)\n* Use of melatonin, agomelatine, or other sleep medications\n* Night worker\n* REM sleep behavior disorder, OSAS\n\nHealthy controls\n\n* Age \\< 18 years old\n* Pregnancy\n* Pacemaker or other ferromagnetic material that is not MRI compatible\n* Mild cognitive impairment or dementia of any cause\n* Epilepsy\n* Multiple sclerosis or other demyelinating disease\n* Depression, psychosis or other mental disease\n* Use of anti-epileptic drugs\n* Alcohol or substance abuse\n* Symptomatic liver disease\n* Uncontrolled thyroid disorders\n* Untreated HIV or syphilis\n* Clinically significant vitamin B12 deficiency\n* Severe systemic medical illness (eg end-stage cardiac disease, …)\n* Use of melatonin, agomelatine, or other sleep medications\n* Night worker\n* REM sleep behavior disorder, OSAS"}, 'identificationModule': {'nctId': 'NCT04522960', 'acronym': 'MADE', 'briefTitle': "Melatonin in Alzheimer's Disease: Effect on Disease Progression and Epileptiform Activity.", 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': "Melatonin in Alzheimer's Disease: Effect on Disease Progression and Epileptiform Activity.", 'orgStudyIdInfo': {'id': 'UZB-NEU-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with dementia or mild cognitive impairment due to AD', 'description': 'Dementia or MCI due to AD according to NIA-AA research criteria.', 'interventionNames': ['Diagnostic Test: MEG+hdEEG+MRI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteers', 'description': 'Age-and-gender matched healthy controls.', 'interventionNames': ['Diagnostic Test: MEG+hdEEG+MRI']}], 'interventions': [{'name': 'MEG+hdEEG+MRI', 'type': 'DIAGNOSTIC_TEST', 'otherNames': ['Lumbar puncture', 'Long-term EEG monitoring', 'Blood sampling', 'Saliva collection', 'Urine collection', 'Neuropsychological examination'], 'description': 'We will perform several tests:\n\n* Neuropsychological testing to evaluate evolution of cognition during our study.\n* Lumbar puncture, blood sampling, saliva and urine collection to assess melatonin levels at several timepoints within these biological fluids.\n* MEG+hdEEG and MRI (to project MEG information) ; LTM-EEG to detect epileptiform activity in patients and healthy controls', 'armGroupLabels': ['Healthy volunteers', 'Patients with dementia or mild cognitive impairment due to AD']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'state': 'Jette', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Amber Nous, MD', 'role': 'CONTACT', 'email': 'amber.nous@uzbrussel.be', 'phone': '+322 474 94 38'}], 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Sebastiaan Engelborghs, MD, PHD', 'role': 'CONTACT', 'email': 'sebastiaan.engelborghs@uzbrussel.be', 'phone': '02 477 64 10'}, {'name': 'Amber Nous, MD', 'role': 'CONTACT', 'email': 'amber.nous@uzbrussel.be', 'phone': '0479477937'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}