Ignite Creation Date:
2025-12-25 @ 12:55 AM
Ignite Modification Date:
2026-02-03 @ 7:30 AM
Study NCT ID:
NCT00505167
Status:
COMPLETED
Last Update Posted:
2008-12-29
First Post:
2007-07-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Memantine Versus Donepezil in Early Stages of 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008559', 'term': 'Memantine'}, {'id': 'D000077265', 'term': 'Donepezil'}], 'ancestors': [{'id': 'D000547', 'term': 'Amantadine'}, {'id': 'D000218', 'term': 'Adamantane'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D007189', 'term': 'Indans'}, {'id': 'D007192', 'term': 'Indenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-12', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-12-26', 'studyFirstSubmitDate': '2007-07-20', 'studyFirstSubmitQcDate': '2007-07-20', 'lastUpdatePostDateStruct': {'date': '2008-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in the Levels of the metabolite N-acetyl-aspartate in several areas of the brain.', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Changes in the clinical scales observed after treatment', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'Memantine', 'Donepezil', 'Magnetic resonance Spectroscopy', 'randomized trial'], 'conditions': ['Dementia, Alzheimer Type']}, 'referencesModule': {'references': [{'pmid': '19874395', 'type': 'DERIVED', 'citation': "Modrego PJ, Fayed N, Errea JM, Rios C, Pina MA, Sarasa M. Memantine versus donepezil in mild to moderate Alzheimer's disease: a randomized trial with magnetic resonance spectroscopy. Eur J Neurol. 2010 Mar;17(3):405-12. doi: 10.1111/j.1468-1331.2009.02816.x. Epub 2009 Oct 28."}]}, 'descriptionModule': {'briefSummary': "It is well known that in the brain of the patients with Alzheimer's disease there is a glutamatergic hyperstimulation leading to neuronal death. Memantine is a low affinity antagonist of NMDA glutamate receptors. The use of this drug in the early phases of the disease could provide neuroprotective effects and delay of progression. The effects of memantine should be compared to those of donepezil, which is the most prescribed anticholinesterase drug.", 'detailedDescription': "On the basis of the excess of glutamatergic stimulation, our objective is to demonstrate whether memantine could have a neuroprotective effect in Alzheimer's disease when administered in the early stages and in comparison to donepezil. The patients would be randomized to receive one of these drugs. At baseline we would evaluate the patients from a clinical standpoint with the ADAS-cog, the neuropsychiatric Inventory and a scale of daily living activities.We also would carry out Magnetic Resonance Spectroscopy in several areas of the brain (medial temporal lobe, prefrontal region, cingulate gyrus and occipital lobe) so as to measure the concentration of N-acetyl-aspartate which is a marker of neuronal density.Then we treat the patients with either memantine or denepezil and after 6 months we would repeat the same procedures as we did at baseline."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical criteria of probable Alzheimer's disease in the stages mild-to-moderate with a Mini-Mental score higher than 15 points.\n\nExclusion Criteria:\n\n* Previous treatment with anticholinesterase drugs or memantine.\n* Advanced stages of the disease\n* Lack of a reliable caregiver.\n* Dementias other than Alzheimer's disease"}, 'identificationModule': {'nctId': 'NCT00505167', 'briefTitle': "Memantine Versus Donepezil in Early Stages of Alzheimer's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Hospital Miguel Servet'}, 'officialTitle': "Memantine Versus Donepezil in Mild to Moderate Alzheimer's Disease. A Randomized Trial With Magnetic Resonance Spectroscopy.", 'orgStudyIdInfo': {'id': '0910-0459'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Patients randomized to receive memantine', 'interventionNames': ['Drug: Memantine']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'Patients randomized to receive donepezil', 'interventionNames': ['Drug: Donepezil']}], 'interventions': [{'name': 'Memantine', 'type': 'DRUG', 'otherNames': ['Ebixa (Memantine)'], 'description': 'Patients randomized to receive either memantine or donepezil', 'armGroupLabels': ['1']}, {'name': 'Donepezil', 'type': 'DRUG', 'otherNames': ['Aricept (Donepezil)'], 'description': 'Patients randomized to receive either memantine or donepezil', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50508', 'city': 'Barbastro', 'state': 'Huesca', 'country': 'Spain', 'facility': 'Hospital de Barbastro', 'geoPoint': {'lat': 42.03565, 'lon': 0.12686}}, {'zip': '50008', 'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Cenro de especialidades San José. Hospital Miguel Servet', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}, {'city': 'Zaragoza', 'country': 'Spain', 'facility': 'Hospital Royo Villanova', 'geoPoint': {'lat': 41.65606, 'lon': -0.87734}}], 'overallOfficials': [{'name': 'Pedro J Modrego, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Neurology. Hospital Miguel Servet. Zaragoza. Spain'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Miguel Servet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Clinica Quiron de Zaragoza', 'class': 'UNKNOWN'}, {'name': 'Universidad de Zaragoza', 'class': 'OTHER'}, {'name': 'Hospital de Barbastro', 'class': 'UNKNOWN'}, {'name': 'Hospital Royo Villanova', 'class': 'UNKNOWN'}], 'responsibleParty': {'oldNameTitle': 'Dr Pedro J Modrego', 'oldOrganization': 'Department of Neurology. hospital Miguel Servet. Zaragoza. Spain'}}}}