Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease|
|Study Start Date:||September 2001|
|Study Completion Date:||March 2005|
|Primary Completion Date:||March 2005 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065767
|United States, Wisconsin|
|University of Wisconsin Memory Research Program|
|Madison, Wisconsin, United States, 53705|
|Principal Investigator:||Sanjay Asthana, MD||William S. Middleton VA Hospital, University of Wisconsin Memory Research Program|