Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Information source: National Institute on Aging (NIA)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Alzheimer Disease
Intervention: Raloxifene (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: University of Wisconsin, Madison Official(s) and/or principal investigator(s):
Sanjay Asthana, MD, Principal Investigator, Affiliation: William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
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.
Clinical Details
Official title: Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
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.
Eligibility
Minimum age: 55 Years.
Maximum age: 90 Years.
Gender(s): Female.
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
Locations and Contacts
University of Wisconsin Memory Research Program, Madison, Wisconsin 53705, United States
Additional Information
University of Wisconsin Memory Research Program
Related publications: 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. Review. 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. Review. Yaffe K. Estrogens, selective estrogen receptor modulators, and dementia: what is the evidence? Ann N Y Acad Sci. 2001 Dec;949:215-22. Review.
Starting date: September 2001
Ending date: December 2004
Last updated: March 23, 2006
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