Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Primary Purpose
Alzheimer Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Raloxifene
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer disease, Postmenopausal women, Hormone therapy
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Sites / Locations
- University of Wisconsin Memory Research Program
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00065767
First Posted
July 31, 2003
Last Updated
October 1, 2015
Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT00065767
Brief Title
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Official Title
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
March 2005 (Actual)
Study Completion Date
March 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Wisconsin, Madison
Collaborators
National Institute on Aging (NIA)
4. Oversight
5. Study Description
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.
Detailed Description
The aim of this study is to determine the effectiveness of treatment with raloxifene, an estrogen-like medication (classified as Selective Estrogen Receptor Modulators (SER's)) 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. Patients who volunteer for this study will need to visit the clinic 7 times (participate) over a period of five months and will receive either raloxifene or a harmless, inactive pill called a placebo. Neither the volunteers nor the study staff will know which type of 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 pills on schedule over a period of three months.
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 20 patients is being recruited to participate in this study at the University of Wisconsin.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
Alzheimer disease, Postmenopausal women, Hormone therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Raloxifene
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Asthana, MD
Organizational Affiliation
William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Wisconsin Memory Research Program
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
11296734
Citation
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.
Results Reference
background
PubMed Identifier
12371603
Citation
Zec 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.
Results Reference
background
PubMed Identifier
11795356
Citation
Yaffe 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.
Results Reference
background
Learn more about this trial
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
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