Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
3 other identifiers
interventional
20
1 country
1
Brief Summary
The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication approved by the Food and Drug Administration for the treatment of osteoporosis, in improving memory and the ability to live independently in postmenopausal women with Alzheimer's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 alzheimer-disease
Started Sep 2001
Typical duration for phase_2 alzheimer-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2001
CompletedFirst Submitted
Initial submission to the registry
July 31, 2003
CompletedFirst Posted
Study publicly available on registry
August 4, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2005
CompletedOctober 5, 2015
September 1, 2010
3.5 years
July 31, 2003
October 1, 2015
Conditions
Keywords
Interventions
Eligibility Criteria
You may qualify if:
- Postmenopausal women with Alzheimer's disease and without other dementias (diagnosed by study staff or from an outside clinic)
- Mini Mental Status Exam score greater than 15/30
You may not qualify if:
- History of deep vein thrombosis or blot clots
- Diabetes
- Active heart disease or stroke
- Liver problems including hepatitis
- Severe vision or hearing problems
- Tobacco use
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Memory Research Program
Madison, Wisconsin, 53705, United States
Related Publications (3)
Birge SJ, McEwen BS, Wise PM. Effects of estrogen deficiency on brain function. Implications for the treatment of postmenopausal women. Postgrad Med. 2001 Mar;Spec No:11-6.
PMID: 11296734BACKGROUNDZec RF, Trivedi MA. The effects of estrogen replacement therapy on neuropsychological functioning in postmenopausal women with and without dementia: a critical and theoretical review. Neuropsychol Rev. 2002 Jun;12(2):65-109. doi: 10.1023/a:1016880127635.
PMID: 12371603BACKGROUNDYaffe K. Estrogens, selective estrogen receptor modulators, and dementia: what is the evidence? Ann N Y Acad Sci. 2001 Dec;949:215-22. doi: 10.1111/j.1749-6632.2001.tb04024.x.
PMID: 11795356BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sanjay Asthana, MD
William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 31, 2003
First Posted
August 4, 2003
Study Start
September 1, 2001
Primary Completion
March 1, 2005
Study Completion
March 1, 2005
Last Updated
October 5, 2015
Record last verified: 2010-09