Ignite Creation Date:
2025-12-24 @ 6:45 PM
Ignite Modification Date:
2025-12-27 @ 5:28 PM
Study NCT ID:
NCT00066157
Status:
COMPLETED
Last Update Posted:
2018-08-23
First Post:
2003-08-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Alzheimer's Disease: Therapeutic Potential of Estrogen
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': 'D015914', 'term': 'Estrogen Replacement Therapy'}, {'id': 'D008525', 'term': 'Medroxyprogesterone'}, {'id': 'D011374', 'term': 'Progesterone'}], 'ancestors': [{'id': 'D020249', 'term': 'Hormone Replacement Therapy'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006908', 'term': 'Hydroxyprogesterones'}, {'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D003339', 'term': 'Corpus Luteum Hormones'}, {'id': 'D042341', 'term': 'Gonadal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045167', 'term': 'Progesterone Congeners'}, {'id': 'D012739', 'term': 'Gonadal Steroid Hormones'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-08', 'completionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-08-22', 'studyFirstSubmitDate': '2003-08-04', 'studyFirstSubmitQcDate': '2003-08-04', 'lastUpdatePostDateStruct': {'date': '2018-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-08-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cognition: delayed recall on Buschke Selective Reminding Test; Stroop Interference condition--completion time and errors; Clinician-rated Interview Based Impression of Change', 'timeFrame': 'Baseline and 1, 3, 6, 12, and 15 months'}], 'secondaryOutcomes': [{'measure': 'Skills of Independent Living: Physical functioning Performance (PFP)', 'timeFrame': 'Baseline and 1, 3, 6, 12, and 15 months'}, {'measure': 'Bioassays (Estradiol, estrone, medroxyprogesterone, FSH, influence of ApoE genotype in responsivity to estrogen)', 'timeFrame': 'Baseline and 1, 3, 6, 12, and 15 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Alzheimer disease', 'Hormone replacement therapy', 'Postmenopausal women'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '12149049', 'type': 'BACKGROUND', 'citation': "Cholerton B, Gleason CE, Baker LD, Asthana S. Estrogen and Alzheimer's disease: the story so far. Drugs Aging. 2002;19(6):405-27. doi: 10.2165/00002512-200219060-00002."}, {'pmid': '11524467', 'type': 'BACKGROUND', 'citation': 'Asthana S, Baker LD, Craft S, Stanczyk FZ, Veith RC, Raskind MA, Plymate SR. High-dose estradiol improves cognition for women with AD: results of a randomized study. Neurology. 2001 Aug 28;57(4):605-12. doi: 10.1212/wnl.57.4.605.'}, {'pmid': '10399774', 'type': 'BACKGROUND', 'citation': "Asthana S, Craft S, Baker LD, Raskind MA, Birnbaum RS, Lofgreen CP, Veith RC, Plymate SR. Cognitive and neuroendocrine response to transdermal estrogen in postmenopausal women with Alzheimer's disease: results of a placebo-controlled, double-blind, pilot study. Psychoneuroendocrinology. 1999 Aug;24(6):657-77. doi: 10.1016/s0306-4530(99)00020-7."}]}, 'descriptionModule': {'briefSummary': "This is a 15-month study to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.", 'detailedDescription': "Estrogen is a naturally occurring hormone produced in a woman's body. The purpose of this 15-month study is to determine the effectiveness of hormone replacement therapy in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease and without other dementias.\n\nPatients who volunteer for this study will either receive a patch containing 17-ß-estradiol or will receive an inactive placebo patch. In addition, patients will be given either medroxyprogesterone or an inactive placebo pill. Neither the volunteers nor the study staff will know which type of patch or pill a patient receives. Patients must be generally healthy and have mild-to-moderate dementia. There must be a patient caregiver who can watch for side effects and ensure that the patient takes the study medications on schedule. Patients will undergo neuropsychological tests and an evaluation of the ability to live independently at each visit as well as laboratory evaluations, such as the taking of blood. Each visit will last approximately 3 hours. A total of 160 participants are being recruited."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)\n* Mini Mental State Examination score greater than 15/30\n\nExclusion Criteria:\n\n* History of cancer of reproductive tissues\n* History of deep vein thrombosis or blot clots\n* Diabetes\n* Heart disease or stroke\n* Liver problems including hepatitis\n* Severe vision or hearing problems\n* Tobacco use\n* Lack of an adequate caregiver\n* inability to perform psychometric testing"}, 'identificationModule': {'nctId': 'NCT00066157', 'briefTitle': "Alzheimer's Disease: Therapeutic Potential of Estrogen", 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': "Alzheimer's Disease: Therapeutic Potential of Estrogen", 'orgStudyIdInfo': {'id': '2001-477'}, 'secondaryIdInfos': [{'id': 'R01AG017196-03', 'link': 'https://reporter.nih.gov/quickSearch/R01AG017196-03', 'type': 'NIH'}, {'id': 'FDA IRB approval M1285'}, {'id': 'NIH grant AG17196-03'}, {'id': 'IA0048', 'type': 'OTHER', 'domain': 'Study Team'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'estradiol patch and medroxyprogesterone', 'interventionNames': ['Drug: Transdermal estradiol', 'Drug: Medroxyprogesterone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'estradiol patch and placebo pill', 'interventionNames': ['Drug: Transdermal estradiol', 'Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '3', 'description': 'placebo patch and medroxyprogesterone', 'interventionNames': ['Drug: Medroxyprogesterone', 'Drug: Placebo Patch']}, {'type': 'PLACEBO_COMPARATOR', 'label': '4', 'description': 'placebo patch and placebo pill', 'interventionNames': ['Drug: Placebo Patch', 'Drug: Placebo']}], 'interventions': [{'name': 'Transdermal estradiol', 'type': 'DRUG', 'otherNames': ['17 (beta) estradiol transdermal patch', 'Estrogen replacement therapy'], 'description': '50 micrograms (low-dose) or 100 micrograms (high-dose) transdermal 17-ß-estradiol patch, changed every 3 days, for 12 months', 'armGroupLabels': ['1', '2']}, {'name': 'Medroxyprogesterone', 'type': 'DRUG', 'otherNames': ['progesterone'], 'description': '2.5mg tablet daily for 12 months', 'armGroupLabels': ['1', '3']}, {'name': 'Placebo Patch', 'type': 'DRUG', 'description': 'Transdermal placebo patch, changed every 3 days, for 12 months', 'armGroupLabels': ['3', '4']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet daily for 12 months', 'armGroupLabels': ['2', '4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Memory Research Program', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Sanjay Asthana, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Wisconsin - Madison, William S. Middleton VA Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}