Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:47 AM
Study NCT ID:
NCT00151502
Status:
COMPLETED
Last Update Posted:
2021-02-18
First Post:
2005-09-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.
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': 'D000069059', 'term': 'Atorvastatin'}], 'ancestors': [{'id': 'D011758', 'term': 'Pyrroles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006538', 'term': 'Heptanoic Acids'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2007-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-17', 'studyFirstSubmitDate': '2005-09-06', 'studyFirstSubmitQcDate': '2005-09-08', 'lastUpdatePostDateStruct': {'date': '2021-02-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2005-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "If the results of this study demonstrate efficacy and lead to the approval by the FDA of atorvastatin for use in humans for the treatment of Alzheimer's disease, this would be available as an additional treatment option for patients."}], 'secondaryOutcomes': [{'measure': 'If the results of this study demonstrate efficacy and lead to the approval by the Food and Drug Administration of atorvastatin for use in humans, subject activities of daily living are being assessed.'}]}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A2581078&StudyName=To%20Evaluate%20the%20Safety%20and%20Effectiveness%20of%20Atorvastatin%20Plus%20a%20Cholinesterase%20Inhibitor%20in%20AD%20Patients.', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to find out if atovastatin, when taken with a cholinesterase inhibitor, is effective for treating Alzheimer's disease."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnostic evidence of probable Alzheimer's disease consistent with NINCDS/ADRDA and DSM IV criteria.\n* Subject's Mini-Mental Status Examination Score (MMSE) must be in the range of 13 - 25 (inclusive) at Screening.\n\nExclusion Criteria:\n\n* Subjects with dementia due to causes other than Alzheimer's disease.\n* Any condition, which, in the investigator's judgment might increase the risk to the subject or decrease the reliability of the data required to meet the objectives of the study."}, 'identificationModule': {'nctId': 'NCT00151502', 'briefTitle': 'To Evaluate the Safety and Effectiveness of Atorvastatin Plus a Cholinesterase Inhibitor in AD Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': "An 80-Week, Randomized, Multi-Center, Parallel-Group, Double-Blind Study of the Efficacy and Safety of Atorvastatin 80 MG Plus an 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