Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00065767|
Recruitment Status : Completed
First Posted : August 4, 2003
Last Update Posted : October 5, 2015
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer Disease||Drug: Raloxifene||Phase 2 Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Cognitive and Neurophysiological Effects of Raloxifene in Alzheimer's Disease|
|Study Start Date :||September 2001|
|Actual Primary Completion Date :||March 2005|
|Actual Study Completion Date :||March 2005|
U.S. FDA Resources
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|