Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2026-01-22 @ 1:58 AM
Study NCT ID:
NCT01642420
Status:
UNKNOWN
Last Update Posted:
2012-09-13
First Post:
2012-04-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-expensive and Widely Available Tests as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Cerebrospinalfluid (CSF) CSF is analysed to find Alzheimer Disease biomarkers'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2012-09-12', 'studyFirstSubmitDate': '2012-04-13', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2012-09-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Conversion from Mild Cognitive Impairment to Alzheimers disease', 'timeFrame': 'Every year in totally of 3 years', 'description': 'The primary outcome measure is progression of clinical symptoms to an extent where the formal NINCDS-ADRDA criteria for dementia is meet. The progression is based upon clinical symptoms as well as explorative determinants in form of clinical tests, CSF analysis and qEEG analysis.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Alzheimers Disease', 'Mild Cognitive Impairment']}, 'descriptionModule': {'briefSummary': 'Alzheimers disease (AD) is the most common course of cognitive decline and thereby the course of more than half of all cases of dementia. A proper AD diagnosis is rested on a number of examinations and tests, which combined can make AD diagnosis likely. But no single test or examination can unambiguous determine whether the patient has AD or not. Comparatively no examination or test can with accuracy predict whether a healthy person or a person with only mild cognitive (MCI)impairment in time will evolve AD.\n\nQuantitative Electroencephalography (qEEG), cerebrospinal fluid (CSF) biomarkers, linear CT analyses and Timed Up and Go - Dual Task (TUG-DT) are relatively inexpensive and and widely available diagnostic methods, which have the potential to diagnose AD at an early stage in a reliable accurate way. But they also have the potential to predict which patients diagnosed with MCI have particular risk of developing dementia.\n\nThe purpose of the study is to investigate the relations between qEEG, CSF biomarkers, CT analyses and TUG-DT outcome and clinical features in healthy persons as well as patients with MCI and AD Furthermore to investigate whether qEEG or CSF biomarkers can predict which patients with MCI will in time evolve AD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with MCI and AD will be recruitted among consectutively refered patients in a memory clinic. Participation is voluntary Healthy control persons will be recuitted by posters and notices', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor patients:\n\n* age 50 to 90\n* diagnosed with MCI or AD\n* cerebrospinal fluid examination and EEG performed at baseline\n\nFor control persons:\n\n* age 50 to 90\n* MMSE score equal or above 26\n* ACE score equal or above 85\n* Normal physical examination, including normal blood samples, CT of cerebrum and EEG examination\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* psychiatric disease, former depression is allowed if antidepressive treatment has been initiated of a leat 3 months duration\n* Neurologic or somatic disease, including former severe head trauma or neuroinfection\n* Antipsychotic treatment\n* Former severe abuse of alcohol, medication or drugs\n* ECT treatment or anaesthesia within the last 3 months\n* no closely related person to assist the patient\n\nAdditionally exclusion criteria for healthy control persons:\n\n* meet the diagnostic criteria for MCI or AD'}, 'identificationModule': {'nctId': 'NCT01642420', 'acronym': 'DEMPROG', 'briefTitle': 'Non-expensive and Widely Available Tests as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression', 'organization': {'class': 'OTHER', 'fullName': 'Zealand University Hospital'}, 'officialTitle': 'Quantitative Electroencephalography, Cerebrospinal Fluid Biomarkers, Linear CT Analyses and Timed Up and GO Dual Task as Diagnostic Tools in Dementia and Their Ability to Predict Disease Progression.', 'orgStudyIdInfo': {'id': 'DEMPROG 2012'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Mild cognitive impairment', 'description': 'Patients diagnosed with mild cognitive impairment'}, {'label': 'Alzheimers disease', 'description': 'Patients diagnosed with mild Alzheimers disease'}, {'label': 'Healthy control persons', 'description': 'Age matched healthy persons'}]}, 'contactsLocationsModule': {'locations': [{'zip': '4000', 'city': 'Roskilde', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Malene S Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Neurologisk Afd, Roskilde Sygehus', 'geoPoint': {'lat': 55.64152, 'lon': 12.08035}}], 'centralContacts': [{'name': 'Malene s Nielsen, MD', 'role': 'CONTACT', 'email': 'malni@regionsjaelland.dk', 'phone': '0045 2868 0034'}, {'name': 'Peter Høgh, MD, Ph.D', 'role': 'CONTACT', 'email': 'phh@regionsjaelland.dk', 'phone': '0045 4732 2809'}], 'overallOfficials': [{'name': 'Malene S Nielsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Roskilde Hospital, Department of Neurology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zealand University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD student', 'investigatorFullName': 'Malene Schjønning Nielsen', 'investigatorAffiliation': 'Zealand University Hospital'}}}}