Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease

Phase 2

Completed

• Conditions: Alzheimer Disease

• Registration Number: NCT00065767
• Lead Sponsor: University of Wisconsin, Madison

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.

Study Timeline

• Study Start: 2001-09
• Study First Submitted: 2003-07-31
• Study First Submitted QC: 2003-08-01
• Study First Posted: 2003-08-04
• Primary Completion: 2005-03
• Study Completion: 2005-03
• Status Verified: 2010-09
• Last Update Submitted: 2015-10-01
• Last Update Posted: 2015-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Trial Locations

Locations (1)

University of Wisconsin Memory Research Program; 🇺🇸 Madison, Wisconsin, United States