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Home > "C" Clinical Trials Conditions > Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease  Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
For Condition: Alzheimer Disease
Status: Recruiting
Sponsor(s): University of Wisconsin ,
Synopsis: 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.
Details: 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:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: 55 Years/90 Years
Genders: Female
Protocol Entry 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
Total Enrollment: 20
Location and Contact Information:
Overall Study Official:
SanjayAsthana, Principal Investigator, William S. Middleton VA Hospital, University of Wisconsin Memory Research Program
University of Wisconsin Memory Research Program *Recruiting*
Madison, Wisconsin, 53705
United States
Recruiting Memory Program Study Coordinator 866-636-7764
Additional Information:
Study ID Numbers: IA0049; IRB M1285
Study Start Date: September 2001
Record last reviewed: July 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00065767
Other Alzheimer Disease Studies:
1. Investigation into Delay to Diagnosis of Alzheimer's Disease with Exelon (InDDEx)
2. Memory Impairment Study (Mild Cognitive Impairment Study)
3. Study of Aripiprazole in the Treatment of Patients with Psychosis Associated with Dementia of the Alzheimer's Type
4. Bathing persons with Alzheimer's disease aT Home (The BATH Study)
5. Study of Melatonin: Sleep Problems in Alzheimer's Disease
Related Studies:
Other Alzheimer Disease Clinical Trials
Other Wisconsin Clinical Trials
Other Madison Clinical Trials
Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
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